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Heart Failure With Preserved Ejection FractionREHAB-HFpEFNCT05525663

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

A study testing Rehabilitation Intervention in people with Heart Failure With Preserved Ejection Fraction, run by Wake Forest University Health Sciences at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 60 years and older
What is being tested?
Rehabilitation Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
880 participants
Where
1 siteUnited States
Study dates
16 Feb 2023to Jan 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Michael B Nelson, MS contact

336-716-6789

mbnelson@wakehealth.edu

United States1 site, 1 recruiting

  • Atrium Health Wake Forest Baptist

    Winston-Salem, North Carolina, 27157

    Dalane W Kitzman, MD, 336-716-3274, dkitzman@wakehealth.edu

    Michael B Nelson, MS, 336-716-6789, mbnelson@wakehealth.edu

    Recruiting

Other trials in United States

About this study

Official title: Physical Rehabilitation for Older Patients With Acute Heart Failure With Preserved Ejection

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.

Read the detailed description

REHAB-HFpEF, is a multicenter, randomized, attention-controlled, single-blind trial to examine the hypothesis that, a novel, tailored, progressive, multi-domain physical rehabilitation intervention administered to older patients with acute decompensated heart failure (ADHF) with preserved ejection fraction (HFpEF) beginning early during hospitalization and continuing for 12 weeks in a structured outpatient setting, and continuing as a maintenance program will reduce the rate of combined all-cause rehospitalization and death at 6 months (the primary outcome), and reduce major mobility disability (MMD) prevalence at 6 months (the secondary outcome). This trial, REHAB-HFpEF, builds upon preliminary studies, including the phase 2 REHAB-HF trial, which suggests this intervention may yield significant benefits for this population which are largely older, frail, and with few evidence-based treatment options. Participants will be recruited from 20 clinical centers, each of which may have up to 3 tightly-affiliated 'satellite' sites geographically-close, under their direct management. Together, these centers will recruit a total of 880 consenting patients >=60 years old hospitalized with ADHF with HFpEF. Following informed consent and baseline testing, the participants will be randomized in a 1:1 fashion to receive a novel, progressive, multi-domain rehabilitation and exercise training intervention or attention control. The intervention will include strength, balance, endurance, and mobility training and the specific training exercises will be tailored based on participant performance in each of these domains. 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. Those randomized to the attention control will be contacted bi-weekly by study staff to maintain contact, collect information regarding health status, clinical events, and physical activity/exercise, and ensure retention; they do not receive any specific exercise recommendations. Both arms will receive all services ordered by their primary physician (usual care) and undergo measures of physical function, cognitive function, and quality of life (QOL).

Being tested
Rehabilitation Intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rehabilitation InterventionBehavioural

    progressive, multi-domain rehabilitation and exercise training intervention

Study groups in NCT05525663
Study groupRoleWhat they receive
Rehabilitation InterventionExperimentalThe Rehabilitation Intervention is a novel, progressive, multi-domain rehabilitation and exercise training intervention. The intervention will include strength, balance, endurance, and mobility training and the specific training exercises will be tailored based on participant performance in each of these domains. 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.
Receives: Behavioral: Rehabilitation Intervention
Attention ControlNo interventionAttention control participants are contacted bi-weekly by study staff to maintain contact, collect information regarding health status, clinical events, and physical activity/exercise, and ensure retention; they do not receive any specific exercise recommendations.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Combined All-cause Rehospitalization and Death

    Rate of combined all-cause rehospitalizations and death 6 months following discharge from index hospitalization.

    Measured: Month 6

Secondary outcomes (1)

  1. Prevalence of major mobility disability (MMD)

    Percentage of participants with MMD, defined as the inability to walk 160 meters during a 6 minute walk test.

    Measured: Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2022
  2. Study start16 Feb 2023
  3. Primary completionNov 2027 (estimated)
  4. Study completionJan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
880 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05525663
Sponsor's protocol ID
IRB00087718
Other IDs
R01AG078153
Acronym
REHAB-HFpEF
Status last verified
Jul 2026
First submitted
30 Aug 2022
Last updated
6 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pastva AM, Reeves GR, Whellan DJ, Mentz RJ, Chen H, Bertoni AG, Duncan PW, Espeland MA, Reed SD, Nelson MB, O'Connor CM, Kitzman DW; REHAB-HFpEF Trial Investigators. Physical rehabilitation for older patients with acute HFpEF (REHAB-HFpEF) trial: Design and rationale. Am Heart J. 2026 Jul;297:107420. doi: 10.1016/j.ahj.2026.107420. Epub 2026 Mar 10.

    PubMed 41812966

Questions about this trial

What is this clinical trial studying?

A study testing Rehabilitation Intervention in people with Heart Failure With Preserved Ejection Fraction, run by Wake Forest University Health Sciences at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Michael B Nelson, MS (336-716-6789, mbnelson@wakehealth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Combined All-cause Rehospitalization and Death (time frame: Month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05525663, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.

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