Heart Failure With Normal Ejection FractionTRAINING-HFNCT02638961
Inspiratory Muscle Training and Functional Electrical Stimulation for Treatment of HFpEF
A study testing IMT, FES and Standard treatment in people with Heart Failure With Normal Ejection Fraction, run by Universitat Jaume I at 1 site in Spain.
Trial summary
Heart failure (HF) with preserved ejection fraction (HFpEF) has become the most prevalent form of HF in developed countries. Despite its increasing in prevalence, there is no evidence-based effective therapy for HFpEF The purpose of this study was to evaluate whether inspiratory muscle training (IMT), functional… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Normal Ejection Fraction
- What is being tested?
- IMT, FES and Standard treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2015to Mar 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previous history of symptomatic heart failure NYHA (New York Heart Association )functional class ≥II with Normal left ventricular ejection fraction:
- ejection fraction >0.50 by Simpson method
- end-diastolic diameter <60 mm
- Structural heart disease:
- left ventricle hypertrophy/left atrial enlargement and/or
- diastolic dysfunction estimated by 2D echocardiography
- Previous admission for acute heart failure
- Clinical stability, without hospital admissions in the past 3 month
Who cannot join
- Perform a valid baseline exercise test
- Significant primary moderate to severe valvular disease
- Acute coronary syndrome or cardiac surgery within the previous three months
- Signs of ischemia during cardiopulmonary exercise testing
- Significant primary pulmonary disease; including pulmonary arterial hypertension, chronic thromboembolic pulmonary disease or chronic obstructive pulmonary disease
- Any other comorbidity with an expectancy of life less than one year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Inspiratory Muscle Training and Functional Electrical Stimulation for Treatment of Heart Failure With Preserved Ejection Fraction
Heart failure (HF) with preserved ejection fraction (HFpEF) has become the most prevalent form of HF in developed countries. Despite its increasing in prevalence, there is no evidence-based effective therapy for HFpEF The purpose of this study was to evaluate whether inspiratory muscle training (IMT), functional electrical stimulation (FES), or combination of both improve exercise capacity as well as left ventricular diastolic function, biomarkers' profile, quality of life (QoL) and prognosis in patients with HFpEF.
Read the detailed description
This study was designed as a prospective, controlled, randomized, four-armed, efficacy trial of patients with the diagnosis of HFpEF and New York Heart Association functional class II-III/IV, diagnosed according to criteria of the European Society of Cardiology. A computer-generated randomization scheme was used to allocate participants (in a 1:1:1:1 ratio) to receive: 1) a home-based 12-week program of inspiratory muscle training (IMT) or; 2) a 12-week program of functional electrical stimulation (FES) of lower limb muscles or; 3) standard treatment (ST) alone or; 4) combination of IMT and FES. The study is being conducted in a single center in Spain. Independently of staggered entry, the minimum duration of a patient's participation is 6 months (from first to last visit). All patients will provide signed informed consent and the protocol has been approved by the research ethics committee of our center in accordance with the principles of the Declaration of Helsinki and national regulations.
Study population Candidate patients are selected from the outpatient's clinics of HF of the Hospital Clínico Universitario of Valencia.
Study objectives The primary endpoint of the study is a clinical endpoint of three and six months change in peak oxygen uptake (peak VO2).
Secondary endpoints are three and six month changes in echocardiogram parameters, QoL and prognostic biomarkers. The investigators also will specifically focus on number of episodes of worsening HF at 6 months:
- Change in E/e' after three and six months.
- Change in left atrial volume index after three and six months.
- Change in health-related QoL measured by the Minnesota Living With Heart Failure Questionnaire (MLHF) after three and six months.
- Change in natriuretic peptide (NT-proBNP) after three and six months.
- Change in minute ventilation/carbon dioxide production (VE/VCO2) slope after three and six months.
- Number of episodes of acute HF hospitalizations and number of episodes of worsening HF not requiring hospitalization at 6 months.
Intervention
Eligibility assessment and screening visit After reviewing the inclusion/exclusion criteria and signing the informed consent form, a comprehensive medical history, physical examination, anthropometry and examination tests will be performed. The examination tests include: electrocardiogram (ECG) echocardiography, cardiopulmonary exercise testing (CPET), 6-minute walk test (6-MWT), inspiratory muscle function test, QoL assessment by the Minnesota Living With Heart Failure Questionnaire (MLHF) and blood samples for a panel of baseline biomarkers.
Finally, patients are randomized (1:1:1:1) to four groups: 1) ST alone or; 2) a home-based 12-week program of IMT or; 3) a 12-week program of FES or; 4) combination of IMT and FES (IMT+FES) during 12 weeks.
12-week and six months visits All patients will be evaluated after 12-week supervised training, and six months after randomization. Evaluation will include medical history, physical examination, anthropometry and functional and QoL assessment tests (ECG, CPET, 6-MWT, inspiratory muscle function test, MLHF and blood tests).
- Being tested
- IMT, FES, Standard treatment
- Keywords
- heart failure with preserved ejection fraction, physical therapy, exercise capacity, quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMTOther
Also called Inspiratory muscular training
Patients allocated to IMT arm will receive standard medical treatment and will be instructed to train at home twice daily, for 20 minutes each session, and during 12 weeks using a threshold inspiratory muscle trainer (Threshold IMT®, Respironics Inc.). All of them will be instructed by a respiratory therapist and educated to maintain a diaphragmatic breathing during the training period. The subjects start breathing at a resistance equal to 25-30% of their maximal inspiratory pressure (MIP) for 1 week. The respiratory therapist examines the patients at weekly intervals by checking the diary card and measuring their MIP each time. The resistance is modified each session according to their 25-30% of their MIP measured.
FESOther
Also called Functional electrostimulation of lower limbs
Patients allocated to FES arm will receive standard medical treatment and will be trained in a FES program of both legs by a physiotherapist for 45 minutes a day, 2 days per week for a total of 12 weeks. Eight adhesive electrodes are positioned on the skin over the quadriceps and gastrocnemius muscles of both legs. The stimulator is configured to deliver a direct electrical current at 25 Hz for 5 seconds followed by a 5-second rest. The intensity of the stimulation is adjusted to achieve a visible muscle contraction without discomfort.
Standard treatmentOther
Patients allocated to this arm will not receive any physical therapy, only standard medical treatment. They will be checked weekly by a physiotherapist who measures their maximal inspiratory mouth pressure each time.
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment | Placebo comparator | Only standard medical treatment Receives: Other: Standard treatment |
| IMT group | Active comparator | Standard medical treatment associated to Inspiratory muscle training Receives: Other: IMT |
| FES group | Active comparator | Standard medical treatment associated to functional electrostimulation of both legs for 45 minutes a day, 2 days per week for a total of 12 weeks. Receives: Other: FES |
| IMT+FES group | Active comparator | Standard medical treatment associated to combination of inspiratory muscle training and functional electrostimulation of both legs Receives: Other: IMT; Other: FES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional capacity measured as peak oxygen uptake (peak VO2) in ml/min/kg .
Maximal functional capacity will be evaluated with an incremental and symptom-limited cardiopulmonary exercise testing (CORTEX Metamax 3B) on a bicycle ergometer, beginning with a workload of 10 W and increasing stepwise at 10-W increments every 1 min. During exercise, patients were continuously monitored with twelve-lead electrocardiogram and blood pressure measurements every 2 min. Gas exchange data and cardiopulmonary variables were averaged every 10 seconds values. Peak VO2 is considered the highest value of VO2 during the last 20 s of exercise.
The improvement > of 10% in peak VO2 will be considered clinically meaningful
Measured: changes at 12 weeks and 6 months
Secondary outcomes (6)
Functional capacity measured as distance walked in 6 minutes
Patients will be instructed to cover the maximum distance (meters) possible in six minutes, at a self-graded walking speed, pausing to rest when needed. Each subject will undergo 4 tests. The goal of the first one was to allow the patient to familiarize with the test.
Measured: changes at 12 weeks and 6 months
Change in echocardiographic parameter of diastolic disfunction: e' septal (cm/s)
Doppler echocardiogram examination of e' septal (cm/s) will be performed under resting conditions using 2D echocardiography (iE33, Philips). e' septal (cm/s) parameter will be measured according to current guidelines of the European Society of Echocardiography:
Only significant improvements in this parameter will be considered
Measured: changes in rest at 12 weeks and 6 months
Change in echocardiographic parameter of diastolic disfunction: left atrial volume index (mm/m2)
Doppler echocardiogram examination of left atrial volume index (mm/m2) will be performed under resting conditions using 2D echocardiography (iE33, Philips). Left atrial volume index (mm/m2) will be measured according to current guidelines of the European Society of Echocardiography.
Only significant improvements in this parameter will be considered
Measured: changes in rest at 12 weeks and 6 months
Change in echocardiographic parameter of diastolic disfunction: E/e' ratio
Doppler echocardiogram examination of E/e' ratio will be performed under resting conditions using 2D echocardiography (iE33, Philips). E/e' ratio parameter will be measured according to current guidelines of the European Society of Echocardiography.
Only significant improvement in this parameter will be considered
Measured: changes in rest at 12 weeks and 6 months
Change in health-related QoL
Change in health-related QoL will be measured by the Minnesota Living With Heart Failure Questionnaire (no units) Only significant improvements in these parameters will be considered
Measured: changes at 12 weeks and 6 months
Number of rehospitalizations or worsening HF at 6 months
Number of episodes of acute HF hospitalizations and number of episodes of worsening HF not requiring hospitalization at 6 months among different arms.
Measured: changes at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2015 (estimated)
- Study startOct 2015
- Primary completionJan 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heart Failure With Normal Ejection FractionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Jaume I
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Investigacion Sanitaria INCLIVA, Hospital Clínico Universitario de Valencia
- Responsible party
- Sponsor
- Investigators
- Patricia Palau, M.D., PhD, Principal investigator, Universitat Jaume IEloy Domínguez, M.D, Study director, Universitat Jaume IJulio Núñez, M.D., PhD, Study chair, Universitat de Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02638961
- Sponsor's protocol ID
- IMT-FES 01
- Acronym
- TRAINING-HF
- Status last verified
- May 2017
- First submitted
- 1 Dec 2015
- Last updated
- 18 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Palau P, Dominguez E, Nunez E, Schmid JP, Vergara P, Ramon JM, Mascarell B, Sanchis J, Chorro FJ, Nunez J. Effects of inspiratory muscle training in patients with heart failure with preserved ejection fraction. Eur J Prev Cardiol. 2014 Dec;21(12):1465-73. doi: 10.1177/2047487313498832. Epub 2013 Jul 17.
PubMed 23864363Palau P, Nunez E, Dominguez E, Sanchis J, Nunez J. Physical therapy in heart failure with preserved ejection fraction: A systematic review. Eur J Prev Cardiol. 2016 Jan;23(1):4-13. doi: 10.1177/2047487314562740. Epub 2014 Dec 8.
PubMed 25488549Palau P, Lopez L, Dominguez E, de La Espriella R, Campuzano R, Castro A, Minana G, Fernandez-Cisnal A, Sanchis J, Nunez J. Exercise training response according to baseline ferrokinetics in heart failure with preserved ejection fraction: A substudy of the TRAINING-HF trial. J Cachexia Sarcopenia Muscle. 2024 Apr;15(2):681-689. doi: 10.1002/jcsm.13419. Epub 2024 Jan 15.
PubMed 38225218Palau P, Dominguez E, Lopez L, Ramon JM, Heredia R, Gonzalez J, Santas E, Bodi V, Minana G, Valero E, Mollar A, Bertomeu Gonzalez V, Chorro FJ, Sanchis J, Lupon J, Bayes-Genis A, Nunez J. Inspiratory Muscle Training and Functional Electrical Stimulation for Treatment of Heart Failure With Preserved Ejection Fraction: The TRAINING-HF Trial. Rev Esp Cardiol (Engl Ed). 2019 Apr;72(4):288-297. doi: 10.1016/j.rec.2018.01.010. Epub 2018 Mar 16. English, Spanish.
PubMed 29551699
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inspiratory Muscle Training and Functional Electrical Stimulation for Treatment of Heart Failure With Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT02638961
- Acronym / sponsor ID
- TRAINING-HF / IMT-FES 01
- Keywords
- heart failure with preserved ejection fraction, physical therapy, exercise capacity, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Universitat Jaume IUniversity, hospital or other
- Collaborators
- Instituto de Investigacion Sanitaria INCLIVA, Hospital Clínico Universitario de Valencia
- Study start
- Oct 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 23 Dec 2015 (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.
Heart failure (HF) with preserved ejection fraction (HFpEF) has become the most prevalent form of HF in developed countries. Despite its increasing in prevalence, there is no evidence-based effective therapy for HFpEF The purpose of this study was to evaluate whether inspiratory muscle training (IMT), functional electrical stimulation (FES), or combination of both improve exercise capacity as well as left ventricular diastolic function, biomarkers' profile, quality of life (QoL) and prognosis in patients with HFpEF.
Detailed description
This study was designed as a prospective, controlled, randomized, four-armed, efficacy trial of patients with the diagnosis of HFpEF and New York Heart Association functional class II-III/IV, diagnosed according to criteria of the European Society of Cardiology. A computer-generated randomization scheme was used to allocate participants (in a 1:1:1:1 ratio) to receive: 1) a home-based 12-week program of inspiratory muscle training (IMT) or; 2) a 12-week program of functional electrical stimulation (FES) of lower limb muscles or; 3) standard treatment (ST) alone or; 4) combination of IMT and FES. The study is being conducted in a single center in Spain. Independently of staggered entry, the minimum duration of a patient's participation is 6 months (from first to last visit). All patients will provide signed informed consent and the protocol has been approved by the research ethics committee of our center in accordance with the principles of the Declaration of Helsinki and national regulations.
Study population Candidate patients are selected from the outpatient's clinics of HF of the Hospital Clínico Universitario of Valencia.
Study objectives The primary endpoint of the study is a clinical endpoint of three and six months change in peak oxygen uptake (peak VO2).
Secondary endpoints are three and six month changes in echocardiogram parameters, QoL and prognostic biomarkers. The investigators also will specifically focus on number of episodes of worsening HF at 6 months:
- Change in E/e' after three and six months.
- Change in left atrial volume index after three and six months.
- Change in health-related QoL measured by the Minnesota Living With Heart Failure Questionnaire (MLHF) after three and six months.
- Change in natriuretic peptide (NT-proBNP) after three and six months.
- Change in minute ventilation/carbon dioxide production (VE/VCO2) slope after three and six months.
- Number of episodes of acute HF hospitalizations and number of episodes of worsening HF not requiring hospitalization at 6 months.
Intervention
Eligibility assessment and screening visit After reviewing the inclusion/exclusion criteria and signing the informed consent form, a comprehensive medical history, physical examination, anthropometry and examination tests will be performed. The examination tests include: electrocardiogram (ECG) echocardiography, cardiopulmonary exercise testing (CPET), 6-minute walk test (6-MWT), inspiratory muscle function test, QoL assessment by the Minnesota Living With Heart Failure Questionnaire (MLHF) and blood samples for a panel of baseline biomarkers.
Finally, patients are randomized (1:1:1:1) to four groups: 1) ST alone or; 2) a home-based 12-week program of IMT or; 3) a 12-week program of FES or; 4) combination of IMT and FES (IMT+FES) during 12 weeks.
12-week and six months visits All patients will be evaluated after 12-week supervised training, and six months after randomization. Evaluation will include medical history, physical examination, anthropometry and functional and QoL assessment tests (ECG, CPET, 6-MWT, inspiratory muscle function test, MLHF and blood tests).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard treatment | Placebo comparator | Other: Standard treatmentOnly standard medical treatment |
| IMT group | Active comparator | Other: IMTStandard medical treatment associated to Inspiratory muscle training |
| FES group | Active comparator | Other: FESStandard medical treatment associated to functional electrostimulation of both legs for 45 minutes a day, 2 days per week for a total of 12 weeks. |
| IMT+FES group | Active comparator | Other: IMT, Other: FESStandard medical treatment associated to combination of inspiratory muscle training and functional electrostimulation of both legs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Previous history of symptomatic heart failure NYHA (New York Heart Association )functional class ≥II with Normal left ventricular ejection fraction:
- Structural heart disease:
- Previous admission for acute heart failure
- Clinical stability, without hospital admissions in the past 3 month
Key exclusion criteria (6 listed)
- Perform a valid baseline exercise test
- Significant primary moderate to severe valvular disease
- Acute coronary syndrome or cardiac surgery within the previous three months
- Signs of ischemia during cardiopulmonary exercise testing
- Significant primary pulmonary disease; including pulmonary arterial hypertension, chronic thromboembolic pulmonary disease or chronic obstructive pulmonary disease
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 |
|---|---|---|
| IMTAlso: Inspiratory muscular trainingPatients allocated to IMT arm will receive standard medical treatment and will be instructed to train at home twice daily, for 20 minutes each session, and during 12 weeks using a threshold inspiratory muscle trainer (Threshold IMT®, Respironics Inc.). All of them will be instructed by a respiratory therapist and educated to maintain a diaphragmatic breathing during the training period. The subjects start breathing at a resistance equal to 25-30% of their maximal inspiratory pressure (MIP) for 1 week. The respiratory therapist examines the patients at weekly intervals by checking the diary card and measuring their MIP each time. The resistance is modified each session according to their 25-30% of their MIP measured. | Other | IMT group, IMT+FES group |
| FESAlso: Functional electrostimulation of lower limbsPatients allocated to FES arm will receive standard medical treatment and will be trained in a FES program of both legs by a physiotherapist for 45 minutes a day, 2 days per week for a total of 12 weeks. Eight adhesive electrodes are positioned on the skin over the quadriceps and gastrocnemius muscles of both legs. The stimulator is configured to deliver a direct electrical current at 25 Hz for 5 seconds followed by a 5-second rest. The intensity of the stimulation is adjusted to achieve a visible muscle contraction without discomfort. | Other | FES group, IMT+FES group |
| Standard treatmentPatients allocated to this arm will not receive any physical therapy, only standard medical treatment. They will be checked weekly by a physiotherapist who measures their maximal inspiratory mouth pressure each time. | Other | Standard treatment |
Primary outcome
Functional capacity measured as peak oxygen uptake (peak VO2) in ml/min/kg .
Time frame: changes at 12 weeks and 6 months
Maximal functional capacity will be evaluated with an incremental and symptom-limited cardiopulmonary exercise testing (CORTEX Metamax 3B) on a bicycle ergometer, beginning with a workload of 10 W and increasing stepwise at 10-W increments every 1 min. During exercise, patients were continuously monitored with twelve-lead electrocardiogram and blood pressure measurements every 2 min. Gas exchange data and cardiopulmonary variables were averaged every 10 seconds values. Peak VO2 is considered the highest value of VO2 during the last 20 s of exercise. The improvement > of 10% in peak VO2 will be considered clinically meaningful
6 secondary outcomes
Functional capacity measured as distance walked in 6 minutes
Time frame: changes at 12 weeks and 6 months
Change in echocardiographic parameter of diastolic disfunction: e' septal (cm/s)
Time frame: changes in rest at 12 weeks and 6 months
Change in echocardiographic parameter of diastolic disfunction: left atrial volume index (mm/m2)
Time frame: changes in rest at 12 weeks and 6 months
Change in echocardiographic parameter of diastolic disfunction: E/e' ratio
Time frame: changes in rest at 12 weeks and 6 months
Change in health-related QoL
Time frame: changes at 12 weeks and 6 months
Number of rehospitalizations or worsening HF at 6 months
Time frame: changes at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2017.
- Background: PubMed 23864363Palau P, Dominguez E, Nunez E, Schmid JP, Vergara P, Ramon JM, Mascarell B, Sanchis J, Chorro FJ, Nunez J. Effects of inspiratory muscle training in patients with heart failure with preserved ejection fraction. Eur J Prev Cardiol. 2014 Dec;21(12):1465-73. doi: 10.1177/2047487313498832. Epub 2013 Jul 17.
- Background: PubMed 25488549Palau P, Nunez E, Dominguez E, Sanchis J, Nunez J. Physical therapy in heart failure with preserved ejection fraction: A systematic review. Eur J Prev Cardiol. 2016 Jan;23(1):4-13. doi: 10.1177/2047487314562740. Epub 2014 Dec 8.
- Derived from this study: PubMed 38225218Palau P, Lopez L, Dominguez E, de La Espriella R, Campuzano R, Castro A, Minana G, Fernandez-Cisnal A, Sanchis J, Nunez J. Exercise training response according to baseline ferrokinetics in heart failure with preserved ejection fraction: A substudy of the TRAINING-HF trial. J Cachexia Sarcopenia Muscle. 2024 Apr;15(2):681-689. doi: 10.1002/jcsm.13419. Epub 2024 Jan 15.
- Derived from this study: PubMed 29551699Palau P, Dominguez E, Lopez L, Ramon JM, Heredia R, Gonzalez J, Santas E, Bodi V, Minana G, Valero E, Mollar A, Bertomeu Gonzalez V, Chorro FJ, Sanchis J, Lupon J, Bayes-Genis A, Nunez J. Inspiratory Muscle Training and Functional Electrical Stimulation for Treatment of Heart Failure With Preserved Ejection Fraction: The TRAINING-HF Trial. Rev Esp Cardiol (Engl Ed). 2019 Apr;72(4):288-297. doi: 10.1016/j.rec.2018.01.010. Epub 2018 Mar 16. English, Spanish.
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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.
Patricia Palau, M.D., PhD principal investigator
Universitat Jaume I
Eloy Domínguez, M.D study director
Universitat Jaume I
Julio Núñez, M.D., PhD study chair
Universitat de Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMT, FES and Standard treatment in people with Heart Failure With Normal Ejection Fraction, run by Universitat Jaume I at 1 site in Spain.
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 8 inclusion and 6 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: finished, as of the sponsor's last update on 18 May 2017. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional capacity measured as peak oxygen uptake (peak VO2) in ml/min/kg . (time frame: changes at 12 weeks and 6 months). 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 NCT02638961, which also lists 4 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 18 May 2017.