About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Exercise Program
- Usual Care