Exercise-Based Cardiac Rehabilitation for Patients With Heart Failure With Preserved Ejection Fraction (EMPOWER-HFpEF)

Prior treatment

• Acute coronary syndrome, unstable angina, or coronary revascularization within the previous 2 weeks.

Other illness

• Inability to safely participate in a structured exercise-based cardiac rehabilitation program because of severe neurological or musculoskeletal disorders, significant cognitive impairment, or severe psychiatric illness that, in the opinion of the investigator, would interfere with study participation.
• Clinically unstable heart failure at the time of enrollment, defined by the need for intravenous therapy, recent major changes in heart failure treatment, or ongoing heart failure decompensation.
• Severe valvular heart disease considered to be the primary cause of the patient's symptoms.
• Uncontrolled hypertension, defined as resting systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg, or resting heart rate ≥110 beats/min despite guideline-directed medical therapy.
• Severe primary pulmonary disease predominantly limiting functional capacity, including significant pulmonary hypertension, chronic thromboembolic pulmonary disease, or severe chronic obstructive pulmonary disease.
• Primary cardiomyopathy or known infiltrative heart disease.
• Severe non-cardiac comorbidity associated with an estimated life expectancy of less than 1 year, in the opinion of the investigator.

Other

• Inability to provide written informed consent or to comply with study procedures and follow-up requirements.

• Adults aged 18 years or older.
• Diagnosis of heart failure with preserved ejection fraction (HFpEF) according to current clinical guidelines, defined by: a) signs and/or symptoms of heart failure; b) left ventricular ejection fraction ≥50%; c) elevated N-terminal pro-B-type natriuretic peptide (NT-proBNP) (≥220 pg/mL); and, d) objective evidence of structural and/or functional cardiac abnormalities consistent with HFpEF.
• High-risk clinical profile, defined by at least one of the following: a) hospitalization for acute or worsening heart failure within the previous 120 days; b) outpatient worsening heart failure within the previous 120 days requiring emergency department evaluation or intensification of oral or intravenous diuretic therapy in a specialized heart failure clinic; c) recent diagnosis of symptomatic HFpEF (≤120 days) with New York Heart Association (NYHA) functional class II-III; or d) stable symptomatic HFpEF (NYHA class II-III) with at least two of the following comorbidities: hypertension, diabetes mellitus, obesity (body mass index ≥30 kg/m²), chronic kidney disease, dyslipidemia, obstructive sleep apnea, or stable coronary artery disease, together with elevated NT-proBNP (≥220 pg/mL in patients in sinus rhythm or ≥600 pg/mL in patients with atrial fibrillation).
• Clinically stable at the time of enrollment, with no requirement for intravenous therapy or major changes in heart failure treatment during the previous 2 weeks.
• Considered by the investigator to be able to participate in a structured exercise-based cardiac rehabilitation program safely.
• Able and willing to provide written informed consent before any study-specific procedures.