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

Официальное название

Effects of a Supervised Exercise Training Program on Clinical Outcomes, Functional Capacity, and Quality of Life in Patients With Heart Failure With Preserved Ejection Fraction (EMPOWER-HFpEF)

Обзор

Heart failure with preserved ejection fraction (HFpEF) is a common condition among older adults. It is associated with frequent hospitalizations, impaired functional capacity, reduced quality of life, and high healthcare utilization. Despite recent advances in pharmacological therapy, many patients continue to experience recurrent clinical deterioration and functional decline. Exercise-based cardiac rehabilitation has demonstrated benefits in improving physical performance and quality of life. Still, its effect on long-term clinical outcomes in patients with high-risk HFpEF has not been established. The EMPOWER-HFpEF study is a multicenter, randomized, controlled trial designed to evaluate whether an early, individualized, multimodal exercise-based cardiac rehabilitation program improves clinical outcomes compared with usual care in patients with HFpEF. Eligible participants will be randomly assigned in a 1:1 ratio to receive either usual care alone or usual care plus a structured 12-month exercise-based cardiac rehabilitation program. The intervention includes an initial 6-month supervised phase, followed by a 6-month hybrid phase combining supervised sessions with structured home- or community-based exercise to promote long-term adherence and maintenance of physical activity. The primary objective is to determine whether this rehabilitation strategy reduces adverse clinical outcomes, including all-cause mortality, heart failure hospitalizations, all-cause hospitalizations, and outpatient heart failure decompensation, while improving functional capacity and health-related quality of life over 12 months. The results of this study will provide evidence on the effectiveness of a long-term multimodal exercise-based cardiac rehabilitation program as part of the comprehensive management of patients with HFpEF.

Подробное описание

Heart failure with preserved ejection fraction (HFpEF) accounts for more than half of all heart failure cases and is associated with a high burden of recurrent hospitalizations, impaired functional capacity, and reduced health-related quality of life. Despite advances in guideline-directed medical therapy, many patients continue to experience recurrent clinical events and progressive functional decline. Exercise-based cardiac rehabilitation has demonstrated consistent benefits on exercise capacity and quality of life in patients with heart failure; however, robust evidence regarding its impact on long-term clinical outcomes in patients with HFpEF remains limited, particularly in high-risk populations.

EMPOWER-HFpEF is a multicenter, prospective, randomized, controlled clinical trial designed to evaluate the effectiveness of an early, individualized, multimodal exercise-based cardiac rehabilitation program in patients with high-risk HFpEF. Eligible participants will be randomly assigned in a 1:1 ratio to receive either guideline-directed medical therapy alone or guideline-directed medical therapy plus a structured exercise-based cardiac rehabilitation program. The intervention will be delivered over 12 months and consists of an initial 6-month supervised phase, followed by a 6-month hybrid phase that combines supervised and home-based exercise, with the to promote long-term adherence and maintenance of physical activity.

Participants will be followed for 12 months. The study is designed to determine whether this rehabilitation strategy improves clinically relevant outcomes while preserving functional status and health-related quality of life. The results are expected to provide evidence to support the integration of long-term exercise-based cardiac rehabilitation into the routine management of patients with HFpEF.

Вмешательства

• Поведенческое Exercise-Based Cardiac Rehabilitation
  A structured, individualised, multimodal exercise-based cardiac rehabilitation program delivered over 12 months. The intervention includes aerobic exercise, resistance training, inspiratory muscle training, and lifestyle counselling. It consists of an initial 6-month supervised phase, followed by a 6-month hybrid phase that combines supervised and home-based exercise to promote long-term adherence and maintenance of physical activity.
• Другое Guideline-Directed Medical Therapy
  Participants receive guideline-directed medical therapy according to current heart failure guidelines, regular follow-up in the heart failure clinic, lifestyle education, and individualized recommendations to maintain regular physical activity as part of routine clinical care.

Первичные конечные точки

• Hierarchical composite clinical outcome (win ratio) [Срок оценки: 12 months]

Вторичные конечные точки (5)

• All-Cause Mortality [Срок оценки: 12 months]
• Heart Failure Hospitalization or Outpatient Heart Failure Decompensation [Срок оценки: 12 months]
• All-Cause Hospitalization [Срок оценки: 12 months]
• Health-Related Quality of Life [Срок оценки: Baseline and 12 months]
• Physical Function [Срок оценки: Baseline and 12 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.
• Acute coronary syndrome, unstable angina, or coronary revascularization within the previous 2 weeks.
• 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.
• Inability to provide written informed consent or to comply with study procedures and follow-up requirements.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• INCLIVA — Valencia

Идентификаторы

NCT: NCT07727096 · EMPOWER-HFpEF

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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