Effects of a Supervised Training Program on Functional Capacity in Patients With HFpEF and Chronotropic Incompetence

This is a prospective study, blinded for the evaluator, randomized (1:1:1:1) to receive standard management alone or combined with a program of training (aerobic alone or combined with strength exercises) that will be 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. Patients with heart failure with preserved ejection fraction, functional class NYHA II-III, and chronotropic incompetence criteria will be enrolled. A sample size estimation [alfa: 0.05, power: 80%, a 15% loss rate, and at least a delta change of mean peakVO2: +2,4 mL/kg/min (SD±2)] of 80 patients (20 per arm) would be necessary to test our hypothesis.

Inclusion Criteria:Patients diagnosed with heart failure with preserved ejection fraction according to 2021 ESC guidelines for Heart Failure.N-terminal pro-B-type natriuretic peptide (NT-proBNP) >125 pg/mL in the last monthStable symptomatic heart failure patients (New York Heart Association functional class II-III/IV) during the last monthAge ≥ 60 years old.Blunted heart rate (HR) response during a maximal cardiopulmonary exercise testing (CPET), defined as a chronotropic index <0.62 if previous treatment with Beta-blockers or chronotropic index <0.80 in patients without beta-blockers. Chronotropic index= [HRpeak exercise - HRrest] / [220 - age - HRrest]Exclusion Criteria:Inability to perform a valid baseline cardiopulmonary exercise testCardiac pacemakerSignificant primary moderate-to-severe valve diseaseEffort angina or signs of ischemia during CPETPrimary cardiomyopathiesCardiac transplantationAny other comorbidity with a life expectancy of less than one year