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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07118410
Acronym
ERFOCARD
Enrollment
38
Registered
2025-08-12
Start date
2025-08-01
Completion date
2027-09-01
Last updated
2025-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Ventricular Function, Left

Keywords

Cardiac rehabilitation, Resistance training, Blood flow restriction, Cardiac function, Speckle tracking echography, Heart failure with reduced ejection fraction

Brief 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. 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.

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.

Interventions

DEVICEApplication of a vascular restriction device during 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.

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Masking description

The primary endpoint assessor is blinded to the group

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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. * 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

Design outcomes

Primary

MeasureTime frameDescription
RT control groupBaselineLeft 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).
BFR+RT groupBaselineLeft 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).

Secondary

MeasureTime frameDescription
(A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: E/E' and E/A ratioBaselineE/E' and E/A ratio will be measured
(A) other parameters of left ventricular and atrial myocardial function in the control group: Myocardial workBaselineThe global index (constructive work, lost work, and efficiency) will be measured in mmHg%
(A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Myocardial workBaselineThe global index (constructive work, lost work, and efficiency) will be measured in mmHg%
(A) other parameters of left ventricular and atrial myocardial function in the control group: Left atrial deformitiesBaselineLeft atrial deformities will be measured in %
(A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Left atrial deformitiesBaselineLeft atrial deformities will be measured in %
(A) other parameters of left ventricular and atrial myocardial function in the control group: Mechanical dispersionBaselinePost-systolic contractions will be measured in mmHg%
(A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Mechanical dispersionBaselinePost-systolic contractions will be measured in mmHg%
(A) other parameters of left ventricular and atrial myocardial function in the control group: Left ventricle ejection fractionBaselineLeft ventricle ejection fraction will be measured in %
(A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Left ventricle ejection fractionBaselineLeft ventricle ejection fraction will be measured in %
(A) other parameters of left ventricular and atrial myocardial function in the BFR+RTgroup: E/E' and E/A ratioAfter 4 weeks of rehabilitationE/E' and E/A ratio will be measured
(A) other parameters of left ventricular and atrial myocardial function in the control group: Cardiac indexBaselineCardiac index will be measured in L/min/m2
(A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Cardiac indexBaselineCardiac index will be measured in L/min/m2
(A) other parameters of left ventricular and atrial myocardial function in the control group: systolic pulmonary arterial pressure (mmHg)After 4 weeks of rehabilitationSystolic pulmonary arterial pressure will be measured in mmHg
(A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: systolic pulmonary arterial pressure (mmHg)After 4 weeks of rehabilitationSystolic pulmonary arterial pressure will be measured in mmHg
(A) other parameters of left ventricular and atrial myocardial function in the control group: Vmax ITBaselineVmax IT will be measured in m/sec
(A) other parameters of left ventricular and atrial myocardial function in the control group: Tricuspid regurgitation flowBaselineTricuspid regurgitation flow will be measured in m/sec
(A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Tricuspid regurgitation flowBaselineTricuspid regurgitation flow will be measured in m/sec
(A) other parameters of left ventricular and atrial myocardial function in the control group: systolic pulmonary arterial pressureBaselineSystolic pulmonary arterial pressure will be measured in mmHg
(A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: systolic pulmonary arterial pressureBaselineSystolic pulmonary arterial pressure will be measured in mmHg
(A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Vmax ITBaselineVmax IT will be measured in m/sec
(A) other parameters of left ventricular and atrial myocardial function in the control group: Left ventricular volumeBaselineLeft ventricular telesystolic and telediastolic volumes will be measured
(A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Left ventricular volumeBaselineLeft ventricular telesystolic and telediastolic volumes will be measured
(A) other parameters of left ventricular and atrial myocardial function in the control group: Atrial volumeBaselineAtrial telesystolic and telediastolic volumes will be measured
(A) other parameters of left ventricular and atrial myocardial function in the BFR+RT group: Atrial volumeBaselineAtrial telesystolic and telediastolic volumes will be measured
(B) Left cardiac remodeling (left ventricle and atrium) in the control group: Myocardial workBaselineThe global index (constructive work, lost work, and efficiency) will be measured in mmHg%
(B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Myocardial workBaselineThe global index (constructive work, lost work, and efficiency) will be measured in mmHg%
(B) Left cardiac remodeling (left ventricle and atrium) in the control group: Left atrial deformitiesBaselineLeft atrial deformities will be measured in %
(B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Left atrial deformitiesBaselineLeft atrial deformities will be measured in %
(B) Left cardiac remodeling (left ventricle and atrium) in the control group: Mechanical dispersionBaselinePost-systolic contractions will be measured in mmHg%
(B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Mechanical dispersionBaselinePost-systolic contractions will be measured in mmHg%
(B) Left cardiac remodeling (left ventricle and atrium) in the control group: Left ventricle ejection fractionBaselineThe left ventricle ejection fraction will be measured as a percentage
(B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Left ventricle ejection fractionBaselineThe left ventricle ejection fraction will be measured as a percentage
(B) Left cardiac remodeling (left ventricle and atrium) in the control group: E/E' and E/A ratioBaselineThe E/E' and E/A ratio will be measured
(B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: E/E' and E/A ratioBaselineThe E/E' and E/A ratio will be measured
(B) Left cardiac remodeling (left ventricle and atrium) in the control group: cardiac indexBaselineCardiac index will be measured in L/min/m2
(B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: cardiac indexBaselineCardiac index will be measured in L/min/m2
(B) Left cardiac remodeling (left ventricle and atrium) in the control group: Tricuspid regurgitation flowBaselineTricuspid regurgitation flow will be measured in m/sec
(B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Tricuspid regurgitation flowBaselineTricuspid regurgitation flow will be measured in m/sec
(B) Left cardiac remodeling (left ventricle and atrium) in the control group: systolic pulmonary arterial pressureBaselineSystolic pulmonary arterial pressure will be measured in mmHg
(B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: systolic pulmonary arterial pressureBaselineSystolic pulmonary arterial pressure will be measured in mmHg
(B) Left cardiac remodeling (left ventricle and atrium) in the control group: Vmax ITBaselineVmax IT will be measured in m/sec
(B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Vmax ITBaselineVmax IT will be measured in m/sec
(B) Left cardiac remodeling (left ventricle and atrium) in the control group: Atrial volumeBaselineAtrial telesystolic and telediastolic volumes will be measured
(B) Left cardiac remodeling (left ventricle and atrium) in the BFR+RT group: Atrial volumeBaselineAtrial telesystolic and telediastolic volumes will be measured
(C) Stress test measurement in controls : peak oxygen consumptionBaselinePeak oxygen consumption (VO2pic) will be measured in mL/min/kg
(C) Stress test measurement in the BFR+RT group : peak oxygen consumptionBaselinePeak oxygen consumption (VO2pic) will be measured in mL/min/kg
(C) Stress test measurement in the BFR+RT group: peak oxygen consumptionAfter 4 weeks of rehabilitationPeak oxygen consumption (VO2pic) will be measured in mL/min/kg
(C) Stress test measurement in controls : Maximum aerobic powerBaselineMaximum aerobic power will be measured in Watts * First ventilatory threshold (SV1) mL/min/kg
(C) Stress test measurement in the BFR+RT group : Maximum aerobic powerBaselineMaximum aerobic power will be measured in Watts * First ventilatory threshold (SV1) mL/min/kg
(C) Stress test measurement in controls : First ventilatory thresholdBaselineFirst ventilatory threshold will be measured in mL/min/kg
(C) Stress test measurement in the BFR+RT group : First ventilatory thresholdBaselineFirst ventilatory threshold will be measured in mL/min/kg
(C) Muscular evaluation in controls: Peak torqueBaselinePeak torque will be measured in Nm
(C) Muscular evaluation in the BFR+RT group: Peak torqueBaselinePeak torque will be measured in Nm
(C) Muscular evaluation in controls: Maximum repetitionBaselineMaximum repetition will be measured in kilograms
(C) Muscular evaluation in the BFR+RT group: Maximum repetitionBaselineMaximum repetition will be measured in kilograms
(D) Clinical and biological measurement in controls: Body mass indexBaselineBody mass index will be measured in Kg/m2
(D) Clinical and biological measurement in the BFR+RT group: Body mass indexBaselineBody mass index will be measured in Kg/m2
(D) Clinical and biological measurement in controls: Waist circumferenceBaselineWaist circumference will be measured in cm
(D) Clinical and biological measurement in the BFR+RT group: Waist circumferenceBaselineWaist circumference will be measured in cm
(D) Clinical and biological measurement in the BFR+RT group: Lipid profileBaselineLipids will be measured in mmol/L
(D) Clinical and biological measurement in controls: Glycated hemoglobinBaselineGlycated hemoglobin will be measured as a %
(D) Clinical and biological measurement in the BFR+RT group: Glycated hemoglobinBaselineGlycated hemoglobin will be measured as a %
(D) Clinical and biological measurement in controls: Fasting blood glucoseBaselineFasting blood glucose will be measured in g/L
(D) Clinical and biological measurement in the BFR+RT group: Fasting blood glucoseBaselineFasting blood glucose will be measured in g/L
(D) Clinical and biological measurement in controls: Pro-Brain Natriuretic PeptideBaselinePro-Brain Natriuretic Peptide will be measured in ng/L
(D) Clinical and biological measurement in the BFR+RT group: Pro-Brain Natriuretic PeptideBaselinePro-Brain Natriuretic Peptide will be measured in ng/L
(D) Clinical and biological measurement in controls: C-reactive proteinBaselineC-reactive protein will be measured in mg/L
(D) Clinical and biological measurement in controls: Lipid profileBaselineLipids will be measured in mmol/L
(D) Clinical and biological measurement in controls: Micro ribonucleic acidsBaselineMicro ribonucleic acids will be measured in ng/µl
(D) Clinical and biological measurement in the BFR+RT group: Micro ribonucleic acidsBaselineMicro ribonucleic acids will be measured in ng/µl
(D) Clinical and biological measurement in controls: Micro ribonucleic acidAfter 4 weeks of rehabilitationMicro ribonucleic acids will be measured in ng/µl
(D) Clinical and biological measurement in the BFR+RT group: Micro ribonucleic acidAfter 4 weeks of rehabilitationMicro ribonucleic acids will be measured in ng/µl
(E) MacNew Heart Disease Quality of Life score in controlsBaselineThe 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
(E) MacNew Heart Disease Quality of Life score in the BFR+RT groupBaselineThe 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
(F) International Physical Activity Questionnaire in controlsBaselineThe 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.
(F) International Physical Activity Questionnaire in the BFR+RT groupBaselineThe 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.
(D) Clinical and biological measurement in the BFR+RT group: C-reactive proteinBaselineC-reactive protein will be measured in mg/L
(A) other parameters of left ventricular and atrial myocardial function in the control group: E/E' and E/A ratioBaselineE/E' and E/A ratio will be measured

Countries

France

Contacts

Primary ContactClarisse BELVISI
clarisse.belvisi@chu-nimes.fr+33466683459
Backup ContactAnissa MEGZARI
drc@chu-nimes.fr0466684236

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026