Chronic Heart FailureNCT02732990
Peripheral Metabolic Function in Chronic Heart Failure Patients
A study testing Exercise training in people with Chronic Heart Failure, run by Anders Rasmussen Rinnov at 1 site in Denmark.
Trial summary
Exercise intolerance is a major limiting symptom in patients with CHF. However the poor correlation between the hemodynamic parameters of left ventricular performance at rest and exercise performance has led to the concept that peripheral factors such as muscle perfusion and muscle metabolism play a role as… Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- Exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2014to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- New York Heart Association (NYHA) Class II - III
- Ejection fraction <35%
- Heart failure as a result of previous myocardial infarction
- Optimal treatment (ACE-inhibitors, beta-blockers)
- Stable heart failure
- Patients with and without implantable cardioverter defibrillator (ICD)
Who cannot join
- Peripheral vascular disease with symptoms of atherosclerosis (intermittent claudication)
- Aneurysm in a. femoral
- Moderate to severe heart valve disease
- Moderate to severe Chronic Obstructive Pulmonary Disease (COPD) with FEV1 <60%
- Heart Failure Patients with Biventricular pacemaker (BVP)
- Serious heart rhythm disturbances (arrhythmias such as atrial fibrillation and frequent premature ventricular contractions)
Show all 12Show fewer
- Myocardial infarction within the last month
- Unstable angina (angina pectoris)
- Renal failure (creatinine greater than 2.5 mg / dL)
- Severe systemic disease of the nervous system, pulmonary or other severe organ involvement
- BMI> 30
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Centre of Inflammation and Metabolism (CIM), Centre for Physical Activity Research
Copenhagen, 2100
Gregers W Munch, MSc PhD, +45 35459574, gregers.munch@regionh.dk
About this study
Official title: Peripheral Metabolic Function in Chronic Heart Failure Patients: Key to Lessen the Cardiac Load
Exercise intolerance is a major limiting symptom in patients with CHF. However the poor correlation between the hemodynamic parameters of left ventricular performance at rest and exercise performance has led to the concept that peripheral factors such as muscle perfusion and muscle metabolism play a role as determinants of exercise capacity.
Read the detailed description
The pathophysiology behind the breathlessness and fatigue experienced by CHF patients during exercise remains unclear. Recent evidence suggests that the peripheral skeletal muscle, which becomes abnormal in heart failure, is the source of afferent signals which disrupt normal patterns of cardiorespiratory control. When CHF patients exercise, an inappropriately strong sympathetic response further limits exercise tolerance by evoking larger than normal increases in peripheral sympathetic activation at a faster rate than in healthy individuals. A consequence of this exacerbated sympathetic response may be the further sympathetic restraint of blood flow to the active skeletal muscles resulting in hypoperfusion of the muscle vascular bed and fatigue. Small muscle mass exercise training increases muscle oxidative capacity and improves aerobic work capacity in CHF patients. A range of studies is proposed here that will provide an integrative view of the mechanistic basis behind exercise intolerance in CHF and relate the intramuscular metabolic status to the autonomic control of hemodynamics during exercise. An understanding of the mechanistic basis of the improved exercise tolerance with training, independent of improved resting cardiac function, will yield important information regarding the integrated control of blood flow and metabolic demand in CHF and highlight the importance of maintaining the integrity of the peripheral musculature in CHF.
- Conditions
- Chronic Heart Failure
- Being tested
- Exercise training
- Keywords
- Training, One-legged exercise, Peripheral blood flow, Cardiac function, Muscle metaboreflex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingBehavioural
All gruoups will undergo 6 weeks of training intervention either with a small musclemass (one-legged exercise) or whole body exercise (two-legged cycling)
| Study group | Role | What they receive |
|---|---|---|
| Exercise training - Whole body exercise | Experimental | Control subjects will train 2-legged cycling (whole body exercise) for 6 weeks Receives: Behavioral: Exercise training |
| Exercise training - One-legged exercise | Experimental | Control subjects will train high intense one-legged exercise for 6 weeks Receives: Behavioral: Exercise training |
| Exercise training - 2-legged cycling CHF | Experimental | CHF patients will train 2-legged cycling (whole body exercise) for 6 weeks Receives: Behavioral: Exercise training |
| Exercise training - CHF | Experimental | CHF Patients will train high intense one-legged exercise for 6 weeks Receives: Behavioral: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline sympathetic nerve activity after 6 weeks of training
Sympathetic nerve activity, measured in plasma and dialysat with reference to nor-adrenaline.
Measured: 6 weeks
Secondary outcomes (3)
The effect of exercise training on exercise capacity in regards to oxygen uptake
Exercise capacity in regards to oxygen uptake (VO2peak) will be evaluated before and after the training intervention
Measured: 6 weeks
The effect of exercise training on exercise capacity in regards to maximal workload
Exercise capacity in regards to Workload during 2-legged cycling (Wattpeak) will be evaluated before and after the training intervention
Measured: 6 weeks
The effect of exercise training on exercise capacity in regards to a 6 min walk test
Exercise capacity in regards to a 6 min walk test (meters) will be evaluated before and after the training intervention
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2016 (estimated)
- Study startFeb 2014
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anders Rasmussen Rinnov
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anders Rasmussen Rinnov, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Stefan P Mortensen, Dr. Med, Study chair, IMM - Department of Cardiovascular and Renal Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02732990
- Sponsor's protocol ID
- VEK-H-3-2013-048
- Status last verified
- Apr 2016
- First submitted
- 6 Nov 2014
- Last updated
- 11 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Metabolic Function in Chronic Heart Failure Patients: Key to Lessen the Cardiac Load
- ClinicalTrials.gov ID
- NCT02732990
- Acronym / sponsor ID
- VEK-H-3-2013-048
- Conditions
- Chronic Heart Failure
- Keywords
- Training, One-legged exercise, Peripheral blood flow, Cardiac function, Muscle metaboreflex
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Anders Rasmussen RinnovUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 11 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Exercise intolerance is a major limiting symptom in patients with CHF. However the poor correlation between the hemodynamic parameters of left ventricular performance at rest and exercise performance has led to the concept that peripheral factors such as muscle perfusion and muscle metabolism play a role as determinants of exercise capacity.
Detailed description
The pathophysiology behind the breathlessness and fatigue experienced by CHF patients during exercise remains unclear. Recent evidence suggests that the peripheral skeletal muscle, which becomes abnormal in heart failure, is the source of afferent signals which disrupt normal patterns of cardiorespiratory control. When CHF patients exercise, an inappropriately strong sympathetic response further limits exercise tolerance by evoking larger than normal increases in peripheral sympathetic activation at a faster rate than in healthy individuals. A consequence of this exacerbated sympathetic response may be the further sympathetic restraint of blood flow to the active skeletal muscles resulting in hypoperfusion of the muscle vascular bed and fatigue. Small muscle mass exercise training increases muscle oxidative capacity and improves aerobic work capacity in CHF patients. A range of studies is proposed here that will provide an integrative view of the mechanistic basis behind exercise intolerance in CHF and relate the intramuscular metabolic status to the autonomic control of hemodynamics during exercise. An understanding of the mechanistic basis of the improved exercise tolerance with training, independent of improved resting cardiac function, will yield important information regarding the integrated control of blood flow and metabolic demand in CHF and highlight the importance of maintaining the integrity of the peripheral musculature in CHF.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Exercise training - Whole body exercise | Experimental | Behavioral: Exercise trainingControl subjects will train 2-legged cycling (whole body exercise) for 6 weeks |
| Exercise training - One-legged exercise | Experimental | Behavioral: Exercise trainingControl subjects will train high intense one-legged exercise for 6 weeks |
| Exercise training - 2-legged cycling CHF | Experimental | Behavioral: Exercise trainingCHF patients will train 2-legged cycling (whole body exercise) for 6 weeks |
| Exercise training - CHF | Experimental | Behavioral: Exercise trainingCHF Patients will train high intense one-legged exercise for 6 weeks |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- New York Heart Association (NYHA) Class II - III
- Ejection fraction <35%
- Heart failure as a result of previous myocardial infarction
- Optimal treatment (ACE-inhibitors, beta-blockers)
- Stable heart failure
Key exclusion criteria (12 listed)
- Peripheral vascular disease with symptoms of atherosclerosis (intermittent claudication)
- Aneurysm in a. femoral
- Moderate to severe heart valve disease
- Moderate to severe Chronic Obstructive Pulmonary Disease (COPD) with FEV1 <60%
- Heart Failure Patients with Biventricular pacemaker (BVP)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise trainingAll gruoups will undergo 6 weeks of training intervention either with a small musclemass (one-legged exercise) or whole body exercise (two-legged cycling) | Behavioural | Exercise training - 2-legged cycling CHF, Exercise training - CHF, Exercise training - One-legged exercise, Exercise training - Whole body exercise |
Primary outcome
Change from baseline sympathetic nerve activity after 6 weeks of training
Time frame: 6 weeks
Sympathetic nerve activity, measured in plasma and dialysat with reference to nor-adrenaline.
3 secondary outcomes
The effect of exercise training on exercise capacity in regards to oxygen uptake
Time frame: 6 weeks
The effect of exercise training on exercise capacity in regards to maximal workload
Time frame: 6 weeks
The effect of exercise training on exercise capacity in regards to a 6 min walk test
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2016.
Related trials for Chronic Heart Failure
Recruiting
Reducing Fluid Overload in Heart Failure Patients Using a Non-invasive, Renal Independent System
Chronic Heart Failure, CKD Stage 3
Not yet recruiting
SWitching to Appropriate Prescription in Cardiovascular-Kidney-Metabolic Syndrome
Cardiovascular-kidney-metabolic Syndrome, Diabete Type 2
Active, not recruiting
Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
Chronic Heart Failure, Heart Transplant Recipient
Recruiting
Vasopressor Agents in Pulmonary Hypertension Crisis
Pulmonary Arterial Hypertension (PAH), Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
RecruitingPhase 4
Empagliflozin in Heart Failure With Reduced Ejection Fraction and End Stage Renal Disease
Heart Failure With Reduced Ejection Fraction, End Stage Renal Disease on Dialysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan P Mortensen, Dr. Med study chair
IMM - Department of Cardiovascular and Renal Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with Chronic Heart Failure, run by Anders Rasmussen Rinnov at 1 site in Denmark.
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 6 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 11 Apr 2016. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gregers W Munch, MSc PhD (+45 35459574, gregers.munch@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline sympathetic nerve activity after 6 weeks of training (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2016; AzTrials last refreshed its copy on 3 Nov 2026.