AzTrials
AzTrials

Heart FailureERFOCARDNCT07118410

Resistance Exercise With Blood Flow Restriction by Vascular Occlusion on Myocardial Function in Heart Failure With Reduced Ejection Fraction

A study testing Application of a vascular restriction device during resistance training in people with Heart Failure and Ventricular Function, Left, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Exercise is essential in cardiac rehabilitation for heart failure patients.Aerobic training and resistance training are both recommended. Resistance training improves muscle mass and strength and also improves the remodeling of cardiac function, thus reducing exercise intolerance in these patients. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Heart Failure, Ventricular Function, Left
What is being tested?
Application of a vascular restriction device during resistance training
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteFrance
Study dates
5 Dec 2025to 5 Jan 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • LVEF ≤ 50%
  • Patients with an indication for cardiovascular rehabilitation in the first stay or not (according to national recommendations, as soon as possible after an exacerbation or at any time in a patient with chronic heart failure) (Bigot et al., 2024)
  • No medical contraindication to physical activity
  • Patient has given free and informed consent and signed the consent form
  • Patient affiliated with or benefiting from a health insurance scheme

Who cannot join

  • Patient participating in another Category I interventional study, or having participated in another interventional study in the last month
  • Patient in an exclusion period determined by a previous study
  • Patient under court protection, guardianship or curatorship
  • Unable to provide informed consent, or patient refuses to sign consent form
  • Pregnant, parturient or breast-feeding patient
  • Moderate to severe peripheral arterial disease. Arterial Doppler scan for arterial stenosis, with measurement of femoral and distal flows.
Show all 10Show fewer
  • Active or recent deep vein thrombosis. Check with venous Doppler ultrasound, looking for venous compressibility at the roots of the thighs, and 4-point venous ultrasound.
  • Medication known to alter the effects of ischemic conditioning (cyclosporine, glibenclamide).
  • Uncontrolled arterial hypertension
  • Severe valvular disease

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Clarisse BELVISI contact

+33466683459

clarisse.belvisi@chu-nimes.fr

Anissa MEGZARI contact

0466684236

drc@chu-nimes.fr

France1 site, 1 recruiting

  • Nîmes University Hospital

    Nîmes, Gard, 30029

    Recruiting

Other trials in France

About this study

Official title: Effect of Resistance Exercise With Blood Flow Restriction by Vascular Occlusion on Myocardial Function in Heart Failure With Reduced Ejection Fraction

Exercise is essential in cardiac rehabilitation for heart failure patients.Aerobic training and resistance training are both recommended. Resistance training improves muscle mass and strength and also improves the remodeling of cardiac function, thus reducing exercise intolerance in these patients. However, to obtain these adaptations, resistance training must be done at moderate to high intensities, which cannot always be sustained by the most fragile and deconditioned patients, such as those with reduced ejection fraction (Heart failure with reduced Ejection Fraction).

Blood flow restriction (BFR) by vascular occlusion training is an interesting alternative to conventional resistance training for these deconditioned patients. Preclinical and clinical studies have shown that, for low-intensity regimens, resistance training and blood flow restriction by vascular occlusion improves muscle strength and left ventricular function, unlike resistance training alone. Tissue hypoxemia, initiated by vascular occlusion and exacerbated by maintenance of exercise, is a key element in the peripheral adaptations documented in blood flow restriction, triggering a cascade of signaling pathways involving neurohumoral factors in particular, with effects both locally (i.e. striated skeletal muscle) and remotely, on the myocardium among others. The feasibility and safety of blood flow restriction in heart failure patients has been well demonstrated. Left ventricle ejection fraction remains a very global functional index, with poor reproducibility influenced by cardiac load conditions, making it impossible to draw any conclusions as to possible improvements in myocardial function, linked to changes in intrinsic tissue decontractility/relaxation properties. New cardiac imaging techniques like Speckle Tracking Echography have made it possible to assess the effects of blood flow resistance on myocardial function but so far no studies have used these tools to compare the effects of BFR+resistance training and resistance training alone on myocardial function in heart failure patients. It is suggested that resistance training combined with blood flow resistance could further improve cardiac and muscular function compared with resistance training alone, by activating neurohumoral mediators, like certain micro ribonucleic acids.

Read the detailed description

Physical exercise is an essential part of cardiac rehabilitation for heart failure patients. In addition to aerobic training, resistance training is now recommended by scientific societies. Clinical studies report that resistance training contributes not only to peripheral reconditioning, with improved muscle mass and strength, but also to central reconditioning, with improved remodeling and cardiac function, thus reducing the exercise intolerance of heart failure patients. These favorable adaptations are achieved, however, on condition that RT is performed at moderate to high intensities (e.g. >75-80% of maximal repetition), intensities that cannot always be sustained by the most fragile and deconditioned patients, such as those with heart failure with reduced ejection fraction. The guidelines recommend intensities of 40% or less of repetition maximum.

Blood flow restriction (BFR) by vascular occlusion training is an interesting alternative to conventional resistance training, particularly for these most deconditioned patients. Preclinical and clinical studies have clearly established that for low-intensity regimens (around 40% of maximal repetition, an intensity well tolerated by the most fragile patients), resistance training+BFR improves muscle strength and left ventricular function, unlike resistance training alone. Tissue hypoxemia, initiated by vascular occlusion and exacerbated by maintenance of exercise, is a key element in the peripheral adaptations documented in BFR, triggering the activation of a cascade of signaling pathways involving neurohumoral factors in particular, with effects both locally (i.e. striated skeletal muscle) and remotely, on the myocardium among others. The feasibility and safety (i.e. no reported adverse events) of BFR in heart failure patients has been well demonstrated.

Left ventricular ejection fraction remains a very global functional index, with poor reproducibility and influenced by cardiac load conditions, making it impossible to draw any conclusions as to possible improvements in myocardial function, linked to changes in intrinsic tissue decontractility/relaxation properties. Innovative cardiac imaging techniques, such as Speckle Tracking Echography, now enable a detailed assessment of the effects of BFR on myocardial function. However, no study has yet used these tools to compare the effects of BFR+resistance training and resistance training alone on myocardial function in heart failure with reduced ejection patients. It is hypothetically suggested that resistance training combined with BFR could further improve cardiac and muscular function compared with resistance training alone, thanks to the activation of neurohumoral mediators, such as certain micro ribonucleic acids.

Being tested
Application of a vascular restriction device during resistance training
Keywords
Cardiac rehabilitation, Resistance training, Blood flow restriction, Cardiac function, Speckle tracking echography, Heart failure with reduced ejection fraction
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Application of a vascular restriction device during resistance trainingDevice

    Also called Resistance training

    In the BFR-RT group, sessions will consist of 30 repetitions, followed by 3 sets of 15 repetitions at 40% 1-MR (maximal repetition), interspersed with 60 sec of recovery. An arterial occlusion pressure of 50% of systolic pressure will be maintained constant using a digital tourniquet. The cuff will be deflated during the recovery phases.

    In the control group (RT group) it will be the same intervention with same intensities but without using BFR.

Study groups in NCT07118410
Study groupRoleWhat they receive
RT control groupNo interventionPatients on resistance training only. Patients in this group will receive 4 weeks of cardiac rehabilitation with 6 sessions/week, 2 sessions of aerobic training on a cycloergometer and 4 sessions of resistance training
RT+BFR groupExperimentalPatients on resistance training combined with blood flow restriction. Sessions will consist of 30 repetitions, followed by 3 sets of 15 repetitions at 40% 1-MR (maximal repetition), interspersed with 60 sec of recovery. An arterial occlusion pressure of 50% of systolic pressure will be maintained constant using a digital tourniquet. The cuff will be deflated during the recovery phases.
Receives: Device: Application of a vascular restriction device during resistance training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. RT control group

    Left ventricular global longitudinal strain (GLS), calculated from segmental longitudinal strains on apical 4-, 3-, and 2-chamber views using an 18-segment model (Voigt et al 2015).

    Measured: Baseline

  2. BFR+RT group

    Left ventricular global longitudinal strain (GLS), calculated from segmental longitudinal strains on apical 4-, 3-, and 2-chamber views using an 18-segment model (Voigt et al 2015).

    Measured: Baseline

  3. RT control group

    Left ventricular global longitudinal strain (GLS), calculated from segmental longitudinal strains on apical 4-, 3-, and 2-chamber views using an 18-segment model (Voigt et al 2015).

    Measured: After 4 weeks of rehabilitation

  4. BFR+RT group

    Left ventricular global longitudinal strain (GLS), calculated from segmental longitudinal strains on apical 4-, 3-, and 2-chamber views using an 18-segment model (Voigt et al 2015).

    Measured: After 4 weeks of rehabilitation

Secondary outcomes (144)

  1. (A) other parameters of left ventricular and atrial myocardial function in the control group: Myocardial work

    The global index (constructive work, lost work, and efficiency) will be measured in mmHg%

    Measured: Baseline

  2. (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Myocardial work

    The global index (constructive work, lost work, and efficiency) will be measured in mmHg%

    Measured: Baseline

  3. (A) other parameters of left ventricular and atrial myocardial function in the control group: Myocardial work

    The global index (constructive work, lost work, and efficiency) will be measured in mmHg%

    Measured: After 4 weeks of rehabilitation

  4. (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Myocardial work

    The global index (constructive work, lost work, and efficiency) will be measured in mmHg%

    Measured: After 4 weeks of rehabilitation

  5. (A) other parameters of left ventricular and atrial myocardial function in the control group: Left atrial deformities

    Left atrial deformities will be measured in %

    Measured: Baseline

  6. (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Left atrial deformities

    Left atrial deformities will be measured in %

    Measured: Baseline

  7. (A) other parameters of left ventricular and atrial myocardial function in the control group: Left atrial deformities

    Left atrial deformities will be measured in %

    Measured: After 4 weeks of rehabilitation

  8. (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Left atrial deformities

    Left atrial deformities will be measured in %

    Measured: After 4 weeks of rehabilitation

  9. (A) other parameters of left ventricular and atrial myocardial function in the control group: Mechanical dispersion

    Post-systolic contractions will be measured in mmHg%

    Measured: Baseline

  10. (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Mechanical dispersion

    Post-systolic contractions will be measured in mmHg%

    Measured: Baseline

  11. (A) other parameters of left ventricular and atrial myocardial function in the control group: Mechanical dispersion

    Post-systolic contractions will be measured in mmHg%

    Measured: After 4 weeks of rehabilitation

  12. (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Mechanical dispersion

    Post-systolic contractions will be measured in mmHg%

    Measured: After 4 weeks of rehabilitation

  13. (A) other parameters of left ventricular and atrial myocardial function in the control group: Left ventricle ejection fraction

    Left ventricle ejection fraction will be measured in %

    Measured: Baseline

  14. (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Left ventricle ejection fraction

    Left ventricle ejection fraction will be measured in %

    Measured: Baseline

  15. (A) other parameters of left ventricular and atrial myocardial function in the control group: Left ventricle ejection fraction

    Left ventricle ejection fraction will be measured in %

    Measured: After 4 weeks of rehabilitation

  16. (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Left ventricle ejection fraction

    Left ventricle ejection fraction will be measured in %

    Measured: After 4 weeks of rehabilitation

  17. (A) other parameters of left ventricular and atrial myocardial function in the control group: E/E' and E/A ratio

    E/E' and E/A ratio will be measured

    Measured: Baseline

  18. (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: E/E' and E/A ratio

    E/E' and E/A ratio will be measured

    Measured: Baseline

  19. (A) other parameters of left ventricular and atrial myocardial function in the control group: E/E' and E/A ratio

    E/E' and E/A ratio will be measured

    Measured: After 4 weeks of rehabilitation

  20. (A) other parameters of left ventricular and atrial myocardial function in the BFR+RTgroup: E/E' and E/A ratio

    E/E' and E/A ratio will be measured

    Measured: After 4 weeks of rehabilitation

  21. (A) other parameters of left ventricular and atrial myocardial function in the control group: Cardiac index

    Cardiac index will be measured in L/min/m2

    Measured: Baseline

  22. (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Cardiac index

    Cardiac index will be measured in L/min/m2

    Measured: Baseline

  23. (A) other parameters of left ventricular and atrial myocardial function in the control group: Cardiac index

    Cardiac index will be measured in L/min/m2

    Measured: After 4 weeks of rehabilitation

  24. (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Cardiac index

    Cardiac index will be measured in L/min/m2

    Measured: After 4 weeks of rehabilitation

  25. (A) other parameters of left ventricular and atrial myocardial function in the control group: Tricuspid regurgitation flow

    Tricuspid regurgitation flow will be measured in m/sec

    Measured: Baseline

  26. (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Tricuspid regurgitation flow

    Tricuspid regurgitation flow will be measured in m/sec

    Measured: Baseline

  27. (A) other parameters of left ventricular and atrial myocardial function in the control group: Tricuspid regurgitation flow

    Tricuspid regurgitation flow will be measured in m/sec

    Measured: After 4 weeks of rehabilitation

  28. (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Tricuspid regurgitation flow

    Tricuspid regurgitation flow will be measured in m/sec

    Measured: After 4 weeks of rehabilitation

  29. (A) other parameters of left ventricular and atrial myocardial function in the control group: systolic pulmonary arterial pressure

    Systolic pulmonary arterial pressure will be measured in mmHg

    Measured: Baseline

  30. (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: systolic pulmonary arterial pressure

    Systolic pulmonary arterial pressure will be measured in mmHg

    Measured: Baseline

  31. (A) other parameters of left ventricular and atrial myocardial function in the control group: systolic pulmonary arterial pressure (mmHg)

    Systolic pulmonary arterial pressure will be measured in mmHg

    Measured: After 4 weeks of rehabilitation

  32. (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: systolic pulmonary arterial pressure (mmHg)

    Systolic pulmonary arterial pressure will be measured in mmHg

    Measured: After 4 weeks of rehabilitation

  33. (A) other parameters of left ventricular and atrial myocardial function in the control group: Vmax IT

    Vmax IT will be measured in m/sec

    Measured: Baseline

  34. (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Vmax IT

    Vmax IT will be measured in m/sec

    Measured: Baseline

  35. (A) other parameters of left ventricular and atrial myocardial function in the control group: Vmax IT

    Vmax IT will be measured in m/sec

    Measured: After 4 weeks of rehabilitation

  36. (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Vmax IT

    Vmax IT will be measured in m/sec

    Measured: After 4 weeks of rehabilitation

  37. (A) other parameters of left ventricular and atrial myocardial function in the control group: Left ventricular volume

    Left ventricular telesystolic and telediastolic volumes will be measured

    Measured: Baseline

  38. (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Left ventricular volume

    Left ventricular telesystolic and telediastolic volumes will be measured

    Measured: Baseline

  39. (A) other parameters of left ventricular and atrial myocardial function in the control group: Left ventricular volume

    Left ventricular telesystolic and telediastolic volumes will be measured

    Measured: After 4 weeks of rehabilitation

  40. (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Left ventricular volume

    Left ventricular telesystolic and telediastolic volumes will be measured

    Measured: After 4 weeks of rehabilitation

  41. (A) other parameters of left ventricular and atrial myocardial function in the control group: Atrial volume

    Atrial telesystolic and telediastolic volumes will be measured

    Measured: Baseline

  42. (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Atrial volume

    Atrial telesystolic and telediastolic volumes will be measured

    Measured: Baseline

  43. (A) other parameters of left ventricular and atrial myocardial function in the control group: Atrial volume

    Atrial telesystolic and telediastolic volumes will be measured

    Measured: After 4 weeks of rehabilitation

  44. (A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Atrial volume

    Atrial telesystolic and telediastolic volumes will be measured

    Measured: After 4 weeks of rehabilitation

  45. (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Myocardial work

    The global index (constructive work, lost work, and efficiency) will be measured in mmHg%

    Measured: Baseline

  46. (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Myocardial work

    The global index (constructive work, lost work, and efficiency) will be measured in mmHg%

    Measured: Baseline

  47. (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Myocardial work

    The global index (constructive work, lost work, and efficiency) will be measured in mmHg%

    Measured: After 4 weeks of rehabilitation

  48. (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Myocardial work

    The global index (constructive work, lost work, and efficiency) will be measured in mmHg%

    Measured: After 4 weeks of rehabilitation

  49. (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Left atrial deformities

    Left atrial deformities will be measured in %

    Measured: Baseline

  50. (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Left atrial deformities

    Left atrial deformities will be measured in %

    Measured: Baseline

  51. (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Left atrial deformities

    Left atrial deformities will be measured in %

    Measured: After 4 weeks of rehabilitation

  52. (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Left atrial deformities

    Left atrial deformities will be measured in %

    Measured: After 4 weeks of rehabilitation

  53. (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Mechanical dispersion

    Post-systolic contractions will be measured in mmHg%

    Measured: Baseline

  54. (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Mechanical dispersion

    Post-systolic contractions will be measured in mmHg%

    Measured: Baseline

  55. (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Mechanical dispersion

    Post-systolic contractions will be measured in mmHg%

    Measured: After 4 weeks of rehabilitation

  56. (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Mechanical dispersion

    Post-systolic contractions will be measured in mmHg%

    Measured: After 4 weeks of rehabilitation

  57. (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Left ventricle ejection fraction

    The left ventricle ejection fraction will be measured as a percentage

    Measured: Baseline

  58. (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Left ventricle ejection fraction

    The left ventricle ejection fraction will be measured as a percentage

    Measured: Baseline

  59. (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Left ventricle ejection fraction

    The left ventricle ejection fraction will be measured as a percentage

    Measured: After 4 weeks of rehabilitation

  60. (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Left ventricle ejection fraction

    The left ventricle ejection fraction will be measured as a percentage

    Measured: After 4 weeks of rehabilitation

  61. (B) Left cardiac remodeling (left ventricle and atrium) in the control group: E/E' and E/A ratio

    The E/E' and E/A ratio will be measured

    Measured: Baseline

  62. (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: E/E' and E/A ratio

    The E/E' and E/A ratio will be measured

    Measured: Baseline

  63. (B) Left cardiac remodeling (left ventricle and atrium) in the control group: E/E' and E/A ratio

    The E/E' and E/A ratio will be measured

    Measured: After 4 weeks of rehabilitation

  64. (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: E/E' and E/A ratio

    The E/E' and E/A ratio will be measured

    Measured: After 4 weeks of rehabilitation

  65. (B) Left cardiac remodeling (left ventricle and atrium) in the control group: cardiac index

    Cardiac index will be measured in L/min/m2

    Measured: Baseline

  66. (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: cardiac index

    Cardiac index will be measured in L/min/m2

    Measured: Baseline

  67. (B) Left cardiac remodeling (left ventricle and atrium) in the control group: cardiac index

    Cardiac index will be measured in L/min/m2

    Measured: After 4 weeks of rehabilitation

  68. (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: cardiac index

    Cardiac index will be measured in L/min/m2

    Measured: After 4 weeks of rehabilitation

  69. (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Tricuspid regurgitation flow

    Tricuspid regurgitation flow will be measured in m/sec

    Measured: Baseline

  70. (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Tricuspid regurgitation flow

    Tricuspid regurgitation flow will be measured in m/sec

    Measured: Baseline

  71. (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Tricuspid regurgitation flow

    Tricuspid regurgitation flow will be measured in m/sec

    Measured: After 4 weeks of rehabilitation

  72. (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Tricuspid regurgitation flow

    Tricuspid regurgitation flow will be measured in m/sec

    Measured: After 4 weeks of rehabilitation

  73. (B) Left cardiac remodeling (left ventricle and atrium) in the control group: systolic pulmonary arterial pressure

    Systolic pulmonary arterial pressure will be measured in mmHg

    Measured: Baseline

  74. (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: systolic pulmonary arterial pressure

    Systolic pulmonary arterial pressure will be measured in mmHg

    Measured: Baseline

  75. (B) Left cardiac remodeling (left ventricle and atrium) in the control group: systolic pulmonary arterial pressure

    Systolic pulmonary arterial pressure will be measured in mmHg

    Measured: After 4 weeks of rehabilitation

  76. (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: systolic pulmonary arterial pressure

    Systolic pulmonary arterial pressure will be measured in mmHg

    Measured: After 4 weeks of rehabilitation

  77. (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Vmax IT

    Vmax IT will be measured in m/sec

    Measured: Baseline

  78. (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Vmax IT

    Vmax IT will be measured in m/sec

    Measured: Baseline

  79. (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Vmax IT

    Vmax IT will be measured in m/sec

    Measured: After 4 weeks of rehabilitation

  80. (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Vmax IT

    Vmax IT will be measured in m/sec

    Measured: After 4 weeks of rehabilitation

  81. (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Atrial volume

    Atrial telesystolic and telediastolic volumes will be measured

    Measured: Baseline

  82. (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Atrial volume

    Atrial telesystolic and telediastolic volumes will be measured

    Measured: Baseline

  83. (B) Left cardiac remodeling (left ventricle and atrium) in the control group: Atrial volume

    Atrial telesystolic and telediastolic volumes will be measured

    Measured: After 4 weeks of rehabilitation

  84. (B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Atrial volume

    Atrial telesystolic and telediastolic volumes will be measured

    Measured: After 4 weeks of rehabilitation

  85. (C) Stress test measurement in controls : peak oxygen consumption

    Peak oxygen consumption (VO2pic) will be measured in mL/min/kg

    Measured: Baseline

  86. (C) Stress test measurement in the BFR+RT group : peak oxygen consumption

    Peak oxygen consumption (VO2pic) will be measured in mL/min/kg

    Measured: Baseline

  87. (C) Stress test measurement in controls : peak oxygen consumption

    Peak oxygen consumption (VO2pic) will be measured in mL/min/kg

    Measured: After 4 weeks of rehabilitation

  88. (C) Stress test measurement in the BFR+RT group: peak oxygen consumption

    Peak oxygen consumption (VO2pic) will be measured in mL/min/kg

    Measured: After 4 weeks of rehabilitation

  89. (C) Stress test measurement in controls : Maximum aerobic power

    Maximum aerobic power will be measured in Watts

    • First ventilatory threshold (SV1) mL/min/kg

    Measured: Baseline

  90. (C) Stress test measurement in the BFR+RT group : Maximum aerobic power

    Maximum aerobic power will be measured in Watts

    • First ventilatory threshold (SV1) mL/min/kg

    Measured: Baseline

  91. (C) Stress test measurement in controls : Maximum aerobic power

    Maximum aerobic power will be measured in Watts

    • First ventilatory threshold (SV1) mL/min/kg

    Measured: After 4 weeks of rehabilitation

  92. (C) Stress test measurement in the BFR+RT group : Maximum aerobic power

    Maximum aerobic power will be measured in Watts

    • First ventilatory threshold (SV1) mL/min/kg

    Measured: After 4 weeks of rehabilitation

  93. (C) Stress test measurement in controls : First ventilatory threshold

    First ventilatory threshold will be measured in mL/min/kg

    Measured: Baseline

  94. (C) Stress test measurement in the BFR+RT group : First ventilatory threshold

    First ventilatory threshold will be measured in mL/min/kg

    Measured: Baseline

  95. (C) Stress test measurement in controls : First ventilatory threshold

    First ventilatory threshold will be measured in mL/min/kg

    Measured: After 4 weeks of rehabilitation

  96. (C) Stress test measurement in the BFR+RT group : First ventilatory threshold

    First ventilatory threshold will be measured in mL/min/kg

    Measured: After 4 weeks of rehabilitation

  97. (C) Muscular evaluation in controls: Peak torque

    Peak torque will be measured in Nm

    Measured: Baseline

  98. (C) Muscular evaluation in the BFR+RT group: Peak torque

    Peak torque will be measured in Nm

    Measured: Baseline

  99. (C) Muscular evaluation in controls: Peak torque

    Peak torque will be measured in Nm

    Measured: After 4 weeks of rehabilitation

  100. (C) Muscular evaluation in the BFR+RT group: Peak torque

    Peak torque will be measured in Nm

    Measured: After 4 weeks of rehabilitation

  101. (C) Muscular evaluation in controls: Maximum repetition

    Maximum repetition will be measured in kilograms

    Measured: Baseline

  102. (C) Muscular evaluation in the BFR+RT group: Maximum repetition

    Maximum repetition will be measured in kilograms

    Measured: Baseline

  103. (C) Muscular evaluation in controls: Maximum repetition

    Maximum repetition will be measured in kilograms

    Measured: After 4 weeks of rehabilitation

  104. (C) Muscular evaluation in the BFR+RT group: Maximum repetition

    Maximum repetition will be measured in kilograms

    Measured: After 4 weeks of rehabilitation

  105. (D) Clinical and biological measurement in controls: Body mass index

    Body mass index will be measured in Kg/m2

    Measured: Baseline

  106. (D) Clinical and biological measurement in the BFR+RT group: Body mass index

    Body mass index will be measured in Kg/m2

    Measured: Baseline

  107. (D) Clinical and biological measurement in controls: Body mass index

    Body mass index will be measured in Kg/m2

    Measured: After 4 weeks of rehabilitation

  108. (D) Clinical and biological measurement in the BFR+RT group: Body mass index

    Body mass index will be measured in Kg/m2

    Measured: After 4 weeks of rehabilitation

  109. (D) Clinical and biological measurement in controls: Waist circumference

    Waist circumference will be measured in cm

    Measured: Baseline

  110. (D) Clinical and biological measurement in the BFR+RT group: Waist circumference

    Waist circumference will be measured in cm

    Measured: Baseline

  111. (D) Clinical and biological measurement in controls: Waist circumference

    Waist circumference will be measured in cm

    Measured: After 4 weeks of rehabilitation

  112. (D) Clinical and biological measurement in the BFR+RT group: Waist circumference

    Waist circumference will be measured in cm

    Measured: After 4 weeks of rehabilitation

  113. (D) Clinical and biological measurement in controls: Lipid profile

    Lipids will be measured in mmol/L

    Measured: Baseline

  114. (D) Clinical and biological measurement in the BFR+RT group: Lipid profile

    Lipids will be measured in mmol/L

    Measured: Baseline

  115. (D) Clinical and biological measurement in controls: Lipid profile

    Lipids will be measured in mmol/L

    Measured: After 4 weeks of rehabilitation

  116. (D) Clinical and biological measurement in the BFR+RT group: Lipid profile

    Lipids will be measured in mmol/L

    Measured: After 4 weeks of rehabilitation

  117. (D) Clinical and biological measurement in controls: Glycated hemoglobin

    Glycated hemoglobin will be measured as a %

    Measured: Baseline

  118. (D) Clinical and biological measurement in the BFR+RT group: Glycated hemoglobin

    Glycated hemoglobin will be measured as a %

    Measured: Baseline

  119. (D) Clinical and biological measurement in controls: Glycated hemoglobin

    Glycated hemoglobin will be measured as a %

    Measured: After 4 weeks of rehabilitation

  120. (D) Clinical and biological measurement in the BFR+RT group: Glycated hemoglobin

    Glycated hemoglobin will be measured as a %

    Measured: After 4 weeks of rehabilitation

  121. (D) Clinical and biological measurement in controls: Fasting blood glucose

    Fasting blood glucose will be measured in g/L

    Measured: Baseline

  122. (D) Clinical and biological measurement in the BFR+RT group: Fasting blood glucose

    Fasting blood glucose will be measured in g/L

    Measured: Baseline

  123. (D) Clinical and biological measurement in controls: Fasting blood glucose

    Fasting blood glucose will be measured in g/L

    Measured: After 4 weeks of rehabilitation

  124. (D) Clinical and biological measurement in the BFR+RT group: Fasting blood glucose

    Fasting blood glucose will be measured in g/L

    Measured: After 4 weeks of rehabilitation

  125. (D) Clinical and biological measurement in controls: Pro-Brain Natriuretic Peptide

    Pro-Brain Natriuretic Peptide will be measured in ng/L

    Measured: Baseline

  126. (D) Clinical and biological measurement in the BFR+RT group: Pro-Brain Natriuretic Peptide

    Pro-Brain Natriuretic Peptide will be measured in ng/L

    Measured: Baseline

  127. (D) Clinical and biological measurement in controls: Pro-Brain Natriuretic Peptide

    Pro-Brain Natriuretic Peptide will be measured in ng/L

    Measured: After 4 weeks of rehabilitation

  128. (D) Clinical and biological measurement in the BFR+RT group: Pro-Brain Natriuretic Peptide

    Pro-Brain Natriuretic Peptide will be measured in ng/L

    Measured: After 4 weeks of rehabilitation

  129. (D) Clinical and biological measurement in controls: C-reactive protein

    C-reactive protein will be measured in mg/L

    Measured: Baseline

  130. (D) Clinical and biological measurement in the BFR+RT group: C-reactive protein

    C-reactive protein will be measured in mg/L

    Measured: Baseline

  131. (D) Clinical and biological measurement in controls: C-reactive protein

    C-reactive protein will be measured in mg/L

    Measured: After 4 weeks of rehabilitation

  132. (D) Clinical and biological measurement in the BFR+RT group: C-reactive protein

    C-reactive protein will be measured in mg/L

    Measured: After 4 weeks of rehabilitation

  133. (D) Clinical and biological measurement in controls: Micro ribonucleic acids

    Micro ribonucleic acids will be measured in ng/µl

    Measured: Baseline

  134. (D) Clinical and biological measurement in the BFR+RT group: Micro ribonucleic acids

    Micro ribonucleic acids will be measured in ng/µl

    Measured: Baseline

  135. (D) Clinical and biological measurement in controls: Micro ribonucleic acid

    Micro ribonucleic acids will be measured in ng/µl

    Measured: After 4 weeks of rehabilitation

  136. (D) Clinical and biological measurement in the BFR+RT group: Micro ribonucleic acid

    Micro ribonucleic acids will be measured in ng/µl

    Measured: After 4 weeks of rehabilitation

  137. (E) MacNew Heart Disease Quality of Life score in controls

    The MacNew is a self-administered heart disease-specific health-related quality of life [HRQL] questionnaire which addresses 3 major HRQL domains: Emotional, Physical, and Social. Each domain contains 9 questions to be rated as 1 [not very important] to 5 [very important]. These domains can be combined to give a Global HRQL score

    Measured: Baseline

  138. (E) MacNew Heart Disease Quality of Life score in the BFR+RT group

    The MacNew is a self-administered heart disease-specific health-related quality of life [HRQL] questionnaire which addresses 3 major HRQL domains: Emotional, Physical, and Social. Each domain contains 9 questions to be rated as 1 [not very important] to 5 [very important]. These domains can be combined to give a Global HRQL score

    Measured: Baseline

  139. (E) MacNew Heart Disease Quality of Life score in controls

    The MacNew is a self-administered heart disease-specific health-related quality of life [HRQL] questionnaire which addresses 3 major HRQL domains: Emotional, Physical, and Social. Each domain contains 9 questions to be rated as 1 [not very important] to 5 [very important]. These domains can be combined to give a Global HRQL score

    Measured: After 4 weeks of rehabilitation

  140. (E) MacNew Heart Disease Quality of Life score in the BFR+RT group

    The MacNew is a self-administered heart disease-specific health-related quality of life [HRQL] questionnaire which addresses 3 major HRQL domains: Emotional, Physical, and Social. Each domain contains 9 questions to be rated as 1 [not very important] to 5 [very important]. These domains can be combined to give a Global HRQL score

    Measured: After 4 weeks of rehabilitation

  141. (F) International Physical Activity Questionnaire in controls

    The International Physical Activity Questionnaire is intended for people aged 15 and over. The questionnaire assesses overall physical activity and sedentary time over the last seven days. The questionnaire looks at vigorous and moderate activity, walking, and time spent sitting (sedentary lifestyle), whether during leisure activities, at work, in daily life or during transport. There are several versions of the questionnaire, including a short one (7 questions) and a long one (27 questions), which people can self-administer or answer by telephone, for example. The questionnaire classifies the subject according to 3 levels of activity: inactive, moderate, high.

    Measured: Baseline

  142. (F) International Physical Activity Questionnaire in the BFR+RT group

    The International Physical Activity Questionnaire is intended for people aged 15 and over. The questionnaire assesses overall physical activity and sedentary time over the last seven days. The questionnaire looks at vigorous and moderate activity, walking, and time spent sitting (sedentary lifestyle), whether during leisure activities, at work, in daily life or during transport. There are several versions of the questionnaire, including a short one (7 questions) and a long one (27 questions), which people can self-administer or answer by telephone, for example. The questionnaire classifies the subject according to 3 levels of activity: inactive, moderate, high.

    Measured: Baseline

  143. (F) International Physical Activity Questionnaire in controls

    The International Physical Activity Questionnaire is intended for people aged 15 and over. The questionnaire assesses overall physical activity and sedentary time over the last seven days. The questionnaire looks at vigorous and moderate activity, walking, and time spent sitting (sedentary lifestyle), whether during leisure activities, at work, in daily life or during transport. There are several versions of the questionnaire, including a short one (7 questions) and a long one (27 questions), which people can self-administer or answer by telephone, for example. The questionnaire classifies the subject according to 3 levels of activity: inactive, moderate, high.

    Measured: After 4 weeks of rehabilitation

  144. (F) International Physical Activity Questionnaire in the BFR+RT group

    The International Physical Activity Questionnaire is intended for people aged 15 and over. The questionnaire assesses overall physical activity and sedentary time over the last seven days. The questionnaire looks at vigorous and moderate activity, walking, and time spent sitting (sedentary lifestyle), whether during leisure activities, at work, in daily life or during transport. There are several versions of the questionnaire, including a short one (7 questions) and a long one (27 questions), which people can self-administer or answer by telephone, for example. The questionnaire classifies the subject according to 3 levels of activity: inactive, moderate, high.

    Measured: After 4 weeks of rehabilitation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2025
  2. Study start5 Dec 2025
  3. Primary completion5 Dec 2027 (estimated)
  4. Study completion5 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients will be randomized into two groups : blood flow restriction+resistance training group (BFR+RT) or the resistance training control group (RT). Patients will receive 4 weeks of cardiac rehabilitation with 6 sessions/week, 2 sessions of aerobic training on a cycloergometer and 4 sessions of RT with or without BFR depending on the group. Patients will be assessed at inclusion and at the end of the protocol by speckle tracking echocardiography, cardio-pulmonary test and muscular evaluation on isokinetic dynamometer.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07118410
Sponsor's protocol ID
NIMAO/2024-2/CB-01
Acronym
ERFOCARD
Status last verified
Oct 2026
First submitted
1 Aug 2025
Last updated
21 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ambrosetti M, Abreu A, Corra U, Davos CH, Hansen D, Frederix I, Iliou MC, Pedretti RFE, Schmid JP, Vigorito C, Voller H, Wilhelm M, Piepoli MF, Bjarnason-Wehrens B, Berger T, Cohen-Solal A, Cornelissen V, Dendale P, Doehner W, Gaita D, Gevaert AB, Kemps H, Kraenkel N, Laukkanen J, Mendes M, Niebauer J, Simonenko M, Zwisler AO. Secondary prevention through comprehensive cardiovascular rehabilitation: From knowledge to implementation. 2020 update. A position paper from the Secondary Prevention and Rehabilitation Section of the European Association of Preventive Cardiology. Eur J Prev Cardiol. 2021 May 14;28(5):460-495. doi: 10.1177/2047487320913379.

    PubMed 33611446

  • Badano LP, Kolias TJ, Muraru D, Abraham TP, Aurigemma G, Edvardsen T, D'Hooge J, Donal E, Fraser AG, Marwick T, Mertens L, Popescu BA, Sengupta PP, Lancellotti P, Thomas JD, Voigt JU; Industry representatives; Reviewers: This document was reviewed by members of the 2016-2018 EACVI Scientific Documents Committee. Standardization of left atrial, right ventricular, and right atrial deformation imaging using two-dimensional speckle tracking echocardiography: a consensus document of the EACVI/ASE/Industry Task Force to standardize deformation imaging. Eur Heart J Cardiovasc Imaging. 2018 Jun 1;19(6):591-600. doi: 10.1093/ehjci/jey042.

    PubMed 29596561

  • Beckers PJ, Denollet J, Possemiers NM, Wuyts FL, Vrints CJ, Conraads VM. Combined endurance-resistance training vs. endurance training in patients with chronic heart failure: a prospective randomized study. Eur Heart J. 2008 Aug;29(15):1858-66. doi: 10.1093/eurheartj/ehn222. Epub 2008 May 30.

    PubMed 18515805

  • Bigot M, Guy JM, Monpere C, Cohen-Solal A, Pavy B, Iliou MC, Bosser G, Corone S, Douard H, Farrokhi T, Guerder A, Guillo P, Houppe JP, Pezel T, Pierre B, Roueff S, Thomas D, Verges B, Blanchard JC, Ghannem M, Marcadet D. Cardiac rehabilitation recommendations of the Group Exercise Rehabilitation Sports - Prevention (GERS-P) of the French Society of Cardiology: 2023 update. Arch Cardiovasc Dis. 2024 Aug-Sep;117(8-9):521-541. doi: 10.1016/j.acvd.2024.05.119. Epub 2024 Jul 4. No abstract available.

    PubMed 39174436

  • Billah M, Ridiandries A, Allahwala U, Mudaliar H, Dona A, Hunyor S, Khachigian LM, Bhindi R. Circulating mediators of remote ischemic preconditioning: search for the missing link between non-lethal ischemia and cardioprotection. Oncotarget. 2019 Jan 4;10(2):216-244. doi: 10.18632/oncotarget.26537. eCollection 2019 Jan 4.

    PubMed 30719216

  • Birnbaum Y, Hale SL, Kloner RA. Ischemic preconditioning at a distance: reduction of myocardial infarct size by partial reduction of blood supply combined with rapid stimulation of the gastrocnemius muscle in the rabbit. Circulation. 1997 Sep 2;96(5):1641-6. doi: 10.1161/01.cir.96.5.1641.

    PubMed 9315559

  • Botker HE, Lassen TR, Jespersen NR. Clinical translation of myocardial conditioning. Am J Physiol Heart Circ Physiol. 2018 Jun 1;314(6):H1225-H1252. doi: 10.1152/ajpheart.00027.2018. Epub 2018 Mar 2.

    PubMed 29498531

  • Cahalin LP, Formiga MF, Owens J, Anderson B, Hughes L. Beneficial Role of Blood Flow Restriction Exercise in Heart Disease and Heart Failure Using the Muscle Hypothesis of Chronic Heart Failure and a Growing Literature. Front Physiol. 2022 Jul 6;13:924557. doi: 10.3389/fphys.2022.924557. eCollection 2022.

    PubMed 35874535

  • Caminiti G, Volterrani M, Iellamo F, Marazzi G, Silvestrini M, Giamundo DM, Morsella V, Di Biasio D, Franchini A, Perrone MA. Exercise training for patients with heart failure and preserved ejection fraction. A narrative review. Monaldi Arch Chest Dis. 2025 Oct 14;95(3). doi: 10.4081/monaldi.2024.3030. Epub 2024 Jul 23.

    PubMed 39058025

  • Chen YC, Chen WC, Liu CW, Huang WY, Lu I, Lin CW, Huang RY, Chen JS, Huang CH. Is moderate resistance training adequate for older adults with sarcopenia? A systematic review and network meta-analysis of RCTs. Eur Rev Aging Phys Act. 2023 Nov 29;20(1):22. doi: 10.1186/s11556-023-00333-4.

    PubMed 38030985

  • Danduboyina A, Panjiyar BK, Borra SR, Panicker SS. Cardiovascular Benefits of Resistance Training in Patients With Heart Failure With Reduced Ejection Fraction: A Systematic Review. Cureus. 2023 Oct 27;15(10):e47813. doi: 10.7759/cureus.47813. eCollection 2023 Oct.

    PubMed 38021681

  • Eser P, Trachsel LD, Marcin T, Herzig D, Freiburghaus I, De Marchi S, Zimmermann AJ, Schmid JP, Wilhelm M. Short- and Long-Term Effects of High-Intensity Interval Training vs. Moderate-Intensity Continuous Training on Left Ventricular Remodeling in Patients Early After ST-Segment Elevation Myocardial Infarction-The HIIT-EARLY Randomized Controlled Trial. Front Cardiovasc Med. 2022 Jun 17;9:869501. doi: 10.3389/fcvm.2022.869501. eCollection 2022.

    PubMed 35783836

  • Fayol A, Wack M, Livrozet M, Carves JB, Domenge O, Vermersch E, Mirabel M, Karras A, Le Guen J, Blanchard A, Azizi M, Amar L, Bories MC, Mousseaux E, Carette C, Puymirat E, Hagege A, Jannot AS, Hulot JS. Aetiological classification and prognosis in patients with heart failure with preserved ejection fraction. ESC Heart Fail. 2022 Feb;9(1):519-530. doi: 10.1002/ehf2.13717. Epub 2021 Nov 29.

    PubMed 34841727

  • Ferraz RB, Gualano B, Rodrigues R, Kurimori CO, Fuller R, Lima FR, DE Sa-Pinto AL, Roschel H. Benefits of Resistance Training with Blood Flow Restriction in Knee Osteoarthritis. Med Sci Sports Exerc. 2018 May;50(5):897-905. doi: 10.1249/MSS.0000000000001530.

    PubMed 29266093

  • Junior AF, Schamne JC, Perandini LAB, Chimin P, Okuno NM. Effects of Walking Training with Restricted Blood Flow on HR and HRV Kinetics and HRV Recovery. Int J Sports Med. 2019 Sep;40(9):585-591. doi: 10.1055/a-0942-7479. Epub 2019 Jul 4.

    PubMed 31272111

Questions about this trial

What is this clinical trial studying?

A study testing Application of a vascular restriction device during resistance training in people with Heart Failure and Ventricular Function, Left, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clarisse BELVISI (+33466683459, clarisse.belvisi@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

RT control group (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07118410, which also lists 30 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.

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