Exercise as medicine: can a tailored workout program reduce hospital visits for heart failure patients?
NCT ID NCT07727096
First seen Jul 27, 2026 · Last updated Jul 28, 2026 · Updated 1 time
Summary
This trial tests whether a year-long, supervised exercise program — including aerobic, resistance, and breathing exercises — can improve outcomes for people with heart failure with preserved ejection fraction (HFpEF). Participants are randomly assigned to either usual care or usual care plus the exercise program. The study tracks hospitalizations, quality of life, and physical function over 12 months to see if exercise makes a meaningful difference.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a structured, multimodal exercise-based cardiac rehabilitation program including aerobic exercise, resistance training, inspiratory muscle training, and lifestyle counselling
- What this could lead to
- If it works, this could establish exercise-based cardiac rehabilitation as a standard part of care for patients with HFpEF, potentially reducing hospitalizations and improving daily life.
- What could go wrong
- This is a behavioral intervention, so adherence may vary. The trial is large but still needs to show clear benefits over usual care, which is not guaranteed.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 390 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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INCLIVA
Valencia, 46010, Spain
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