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NCT05525663 · Wake Forest University Health Sciences

Physical Rehabilitation for Older Patients With Acute Heart Failure With Preserved Ejection Fraction

(REHAB-HFpEF)

What this study is about

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.

View original scientific description

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.

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

Inclusion criteria

  • Age \>=60 years old
  • Ejection Fraction \>=45%
  • 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
  • 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
  • Able to walk 4 meters (with or without the use of an assistive device) at the time of enrollment

Exclusion criteria

  • 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)
  • Severe aortic or mitral valve stenosis
  • Severe valvular heart disease with planned intervention within next 6 months
  • Known pericardial constriction, genetic hypertrophic cardiomyopathy, or infiltrative cardiomyopathy including amyloid heart disease (amyloidosis)
  • Planned discharge other than to home or a facility where the participant will live independently
  • Terminal illness other than HF with life expectancy \<1 year
  • Impairment from stroke or other medical disorders that preclude participation in the intervention
  • 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
  • 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
  • Already engaging in regular moderate to vigorous exercise conditioning defined as \>30 minutes per day, \>= twice per week consistently during the previous 6 weeks
  • Enrollment in a clinical trial not approved for co-enrollment
  • High risk for non-adherence as determined by screening evaluation
  • Inability or unwillingness to comply with the study requirements or give consent

Where

  • Winston-Salem, North Carolina

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Jul 6, 2026 · Source of record for eligibility and locations

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1 of 880 participants interested
0% interest

See if this study fits

A short prescreen based on this study's listed criteria. A coordinator confirms eligibility — this is not a medical assessment.

Preparing your pre-screening questions…

Study locations

Choose your preferred location, or select flexible during enrollment.

RECRUITING

Winston-Salem

North Carolina

Location available

Express your interest

Share your contact details and a study coordinator can follow up about screening.

Secure & Confidential

Your information is protected and will only be shared with the research team.

What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

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Looking for Heart Failure With Preserved Ejection Fraction Treatment in Winston?

Join others in Salem exploring innovative treatment options through clinical research

Heart Failure With Preserved Ejection Fraction Treatment Options in Winston, Salem

If you're searching for Heart Failure With Preserved Ejection Fraction treatment in Winston, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Winston and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Heart Failure With Preserved Ejection Fraction. All study-related care is provided at no cost to participants.

Local Sites
1 locations in Salem
Now Enrolling
Up to 880 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Heart Failure With Preserved Ejection Fraction?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Heart Failure With Preserved Ejection Fraction

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Heart Failure With Preserved Ejection Fraction Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT05525663. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.