Physical Rehabilitation for Older Patients With Acute Heart Failure With Preserved Ejection Fraction
Physical Rehabilitation for Older Patients With Acute Heart Failure With Preserved Ejection
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 60 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Mentioned in the study description
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 12 weeks
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "The intervention will begin as soon as possible after randomization during the hospitalization and will continue 3 times per week in an outpatient setting for 12 weeks."
- Compensation
- Mentioned in the study description
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether a new physical rehab program helps adults age 60 and older who are hospitalized with heart failure and still have a heart that pumps at least 45% of its blood with each beat. Over 6 months, it will track hospital stays, deaths, and major trouble walking.
The REHAB-HFpEF trial will determine whether a novel physical rehabilitation intervention will improve the primary outcome of combined all-cause rehospitalizations and mortality and the secondary outcome of major mobility disability during 6-month follow-up in patients hospitalized for heart failure and preserved ejection fraction (HFpEF), which is nearly unique to older persons, and for which there are few treatment options.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are age 60 or older.
- Your heart pumps out at least 45% of its blood with each beat. This is called ejection fraction.
- You have been in the hospital for more than 24 hours for worsening heart failure, or you developed worsening heart failure while hospitalized for another reason.
- A study doctor confirms that heart failure is the main cause of your symptoms. You must have at least one worsening symptom, at least two signs of heart failure, and a change in heart failure medicine.
- Your health is stable enough to take part in the study tests and rehab.
- Before your hospital stay, you could do basic daily tasks and walk on your own, with or without a walking aid.
- At enrollment, you can walk 4 meters, with or without a walking aid.
Who can't join
- You had a heart attack in the past 3 months, or plan to have a procedure to open or bypass heart arteries in the next 6 months.
- You have severe narrowing of the aortic or mitral heart valve, or severe valve disease with a procedure planned within 6 months. Certain other heart problems also rule you out, including a tight sac around the heart, inherited thick heart muscle, or buildup of substances such as amyloid in the heart.
- You will leave the hospital for a place where you will not live independently, or you have an illness other than heart failure expected to limit your life to less than 1 year.
- A stroke or another health problem prevents you from taking part. You have documented dementia, a memory and thinking test score of 18 or less without social support, or a score below 10 with or without support.
- You have advanced kidney disease with a filtering rate below 20, receive dialysis to clean your blood, or expect to need dialysis within 6 months.
- For the past 6 weeks, you have regularly done moderate to hard exercise for more than 30 minutes a day, at least twice a week.
- You are in another clinical trial that has not been approved for participation alongside this study.
- Screening shows a high risk that you will not follow the study plan, or you cannot or do not want to follow study rules or give consent.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. Age \>=60 years old 2. Ejection Fraction \>=45% 3. In the hospital setting \>24 hours for the management of acute decompensated heart failure (ADHF), or diagnosed with ADHF after being hospitalized for another reason. ADHF will be confirmed by the site physician, and will be defined according to the Food and Drug Administration (FDA) definition of hospitalized heart failure as a combination of symptoms, signs, and HF-specific medical treatments, and requires that all 4 of the following are met: * At least 1 symptom of HF which has worsened from baseline: a. dyspnea at rest or with exertion; b. exertional fatigue; c. orthopnea; d. paroxysmal nocturnal dyspnea (PND) * At least 2 of the following signs of HF: a. Pulmonary congestion or edema on physical exam (rales or crackles) or by chest X-ray; b. Elevated jugular venous pressure or central venous pressure \>=10 mm Hg; c. peripheral edema; d. wedge or left ventricular end diastolic pressure \>=15 mmHg; e. rapid weight gain (\>=5 lbs.); f. Increased b-type natriuretic peptide (BNP) (\>=100 pg/ml) or N-terminal prohormone BNP (\>=220pg/ml) * Change in medical treatment specifically targeting HF, defined as change in dose or initiation of or augmentation of at least 1 of the following therapies: a. diuretics; b. vasodilators; c. other neurohormonal modulating agents, including angiotensinconverting enzyme inhibitors, angiotensin II receptor blockers (with or without neprilysin inhibitor), beta-blockers, aldosterone inhibitors, direct renin inhibitors, or sodium-glucose co-transporter-2 inhibitors * The primary cause of symptoms and signs is judged by the investigator to be due to HF 4. Adequate clinical stability to allow participation in study assessments and the intervention Independent with basic activities of daily living, including the ability to ambulate independently (with or without the use of an assistive device) prior to admission 5. Able to walk 4 meters (with or without the use of an assistive device) at the time of enrollment Exclusion Criteria: 1. Acute myocardial infarction within the past 3 months, or planned coronary artery intervention (percutaneous or surgical) within the next 6 months (Note: given that cardiac biomarkers such as troponin are frequently elevated in HF patients, the diagnosis of acute myocardial infarction should be based on clinical diagnosis, not biomarkers alone) 2. Severe aortic or mitral valve stenosis 3. Severe valvular heart disease with planned intervention within next 6 months 4. Known pericardial constriction, genetic hypertrophic cardiomyopathy, or infiltrative cardiomyopathy including amyloid heart disease (amyloidosis) 5. Planned discharge other than to home or a facility where the participant will live independently 6. Terminal illness other than HF with life expectancy \<1 year 7. Impairment from stroke or other medical disorders that preclude participation in the intervention 8. Known dementia by medical record documentation, OR patients with Montreal Cognitive Assessment (MoCA) \<=18 AND without social support, OR MoCA \<10 regardless of social support 9. Advanced chronic kidney disease defined as estimated glomerular filtration rate \<20 mL/min/1.73 m2 or on chronic or intermittent dialysis or dialysis anticipated within the next 6 months 10. Already engaging in regular moderate to vigorous exercise conditioning defined as \>30 minutes per day, \>= twice per week consistently during the previous 6 weeks 11. Enrollment in a clinical trial not approved for co-enrollment 12. High risk for non-adherence as determined by screening evaluation 13. Inability or unwillingness to comply with the study requirements or give consent
Study sites (1)
NC
- Atrium Health Wake Forest Baptist · Winston-Salem, NC 27157Dalane W Kitzman, MD · Study contact · 336-716-3274 · dkitzman@wakehealth.eduMichael B Nelson, MS · Study contact · 336-716-6789 · mbnelson@wakehealth.eduMore trials in Winston-Salem