Actively Recruiting

Phase Not Applicable
Age: 60Years +
All Genders
NCT05525663

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

Led by Wake Forest University Health Sciences · Updated on 2025-07-02

880

Participants Needed

1

Research Sites

254 weeks

Total Duration

On this page

Sponsors

W

Wake Forest University Health Sciences

Lead Sponsor

N

National Institute on Aging (NIA)

Collaborating Sponsor

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 60Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 60 years or older
  • Ejection fraction of 45% or higher
  • Hospitalized for more than 24 hours for acute decompensated heart failure (ADHF) or diagnosed with ADHF during hospitalization
  • ADHF confirmed by physician based on symptoms, signs, and specific heart failure treatments
  • Clinical stability allowing participation in study assessments and intervention
  • Independent in basic activities of daily living, able to ambulate independently before admission
  • Able to walk 4 meters with or without an assistive device at enrollment
Not Eligible

You will not qualify if you...

  • Acute myocardial infarction within past 3 months or planned coronary intervention within next 6 months
  • 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
  • Planned discharge to a facility where the participant will not live independently
  • Terminal illness other than heart failure with life expectancy less than 1 year
  • Impairment from stroke or other medical disorders preventing participation
  • Known dementia or low cognitive assessment scores without social support
  • Advanced chronic kidney disease with very low kidney function or dialysis
  • Regular moderate to vigorous exercise over 30 minutes at least twice weekly in past 6 weeks
  • Enrollment in another clinical trial not approved for co-enrollment
  • High risk for non-adherence
  • Inability or unwillingness to comply with study requirements or give consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, United States, 27157

Actively Recruiting

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Research Team

M

Michael B Nelson, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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