Heart Failure With Preserved Ejection Fraction (HFpEF)SarcopeniaWomen
Investigational drug(s) / intervention(s)
Exercise ProgramUsual Care
Exercise Program: Patients allocated to this arm will receive the usual care plus supervised aerobic and moderate to high-intensity strength training twice weekly.
Usual Care: Patients allocated to this arm will receive standard medical treatment plus explicit recommendations for 12-week home-based moderate-intensity aerobic and strength training. They will also receive a weekly phone call and an in-person monthly visit to monitor exercise training performance.
Study summary
This prospective study will randomize (1:1) women with heart failure with preserved ejection fraction (HFpEF) and sarcopenia to receive standard management alone or a combined 12-week supervised exercise program (combining aerobic and strength exercise) carried out in a single centre.
After randomization, patients will be clinically evaluated. The primary endpoint (peakVO2) will be assessed by cardiopulmonary exercise testing (CPET) at 12 weeks. Women over 60 with HFpEF, functional class NYHA class II-III, and sarcopenia criteria will be enrolled. A sample size estimation \[alfa: 0.05, power: 80%, a 20% loss rate, and at least a delta change of mean peakVO2: +1.9 mL/kg/min (SD±2)\] of 40 patients (20 per arm) would be necessary to test our hypothesis.
Eligibility
Sex
FEMALE
Min age
60 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Patients diagnosed with heart failure with preserved ejection fraction according to 2021 ESC guidelines for Heart Failure, with N-terminal pro-B-type natriuretic peptide (NT-proBNP) \>125 pg/mL, inthe last month.
* Stable symptomatic heart failure patients (New York Heart Association functional class II-III) during the last month.
* Age ≥ 60 years old.
* The participant is willing to give informed consent to participate in the study.
* SARC-F score ≥4 points.
Exclusion Criteria:
* Inability to perform a valid baseline cardiopulmonary exercise test.
* Cardiac pacemaker.
* Significant primary moderate-to-severe valve disease.
* Effort angina or signs of ischemia during CPET.
* Primary cardiomyopathies.
* Cardiac transplantation.
* Any other comorbidity with a life expectancy of less than one year.
Primary outcome measure(s)
Peak oxygen consumption — Primary outcome: Peak oxygen consumption will be evaluated at first visit and after 12 weeks. We will evaluate peak oxygen consumption change from baseline. Maximal functional capacity will be evaluated using incremental and symptom-limited cardiopulmonary exercise testing on a bicycle ergometer, beginning with a workload of 10 W and increasing gradually in a ramp protocol at 10-W increments every 1 minute. We define maximal functional capacity as when the patient stops pedalling because of symptoms and the respiratory exchange ratio (RER) was 1. During exercise, patients will be monitored with 12-lead electrocardiogram and blood pressure measurements every 2 minutes. Gas exchange data and cardiopulmonary variables were averages of values taken every 10 seconds. Peak oxygen consumption (PeakVO2) was defined as the highest value of VO2 during the last 20 seconds of exercise.
Trial sites (1)
Facility
City
Region
Status
Hospital Clínico Universitario de Valencia
Valencia
Spain
More Fundación para la Investigación del Hospital Clínico de Valencia trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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