- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05525663
Physical Rehabilitation for Older Patients With Acute Heart Failure With Preserved Ejection Fraction (REHAB-HFpEF)
Physical Rehabilitation for Older Patients With Acute Heart Failure With Preserved Ejection
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Michael B Nelson, MS
- Phone Number: 336-716-6789
- Email: mbnelson@wakehealth.edu
Study Locations
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North Carolina
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Winston-Salem, North Carolina, United States, 27157
- Recruiting
- Atrium Health Wake Forest Baptist
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Contact:
- Michael B Nelson, MS
- Phone Number: 336-716-6789
- Email: mbnelson@wakehealth.edu
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Contact:
- Dalane W Kitzman, MD
- Phone Number: 336-716-3274
- Email: dkitzman@wakehealth.edu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Rehabilitation Intervention
The 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.
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progressive, multi-domain rehabilitation and exercise training intervention
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No Intervention: Attention Control
Attention 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Combined All-cause Rehospitalization and Death
Time Frame: Month 6
|
Rate of combined all-cause rehospitalizations and death 6 months following discharge from index hospitalization.
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Month 6
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of major mobility disability (MMD)
Time Frame: Month 6
|
Percentage of participants with MMD, defined as the inability to walk 160 meters during a 6 minute walk test.
|
Month 6
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
All-cause rehospitalization
Time Frame: Month 6
|
Exploratory outcome.
Rate of rehospitalizations 6 months following discharge from index hospitalization.
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Month 6
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All-cause death
Time Frame: Month 6
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Exploratory outcome.
Rate of death 6 months following discharge from index hospitalization.
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Month 6
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Cardiovascular rehospitalization and death
Time Frame: Month 6
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Exploratory outcome.
Rate of combined cardiovascular rehospitalizations and death 6 months following discharge from index hospitalization.
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Month 6
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Short Physical Performance Battery (SPPB)
Time Frame: Month 6
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Exploratory outcome.
The Short Physical Performance Battery is scored on a scale of 0-12, with a higher score indicating better physical function.
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Month 6
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6-minute Walk Distance (6MWD)
Time Frame: Month 6
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Exploratory outcome.
Distance walked in 6 minutes.
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Month 6
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Quality of Life Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time Frame: Month 6
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Exploratory outcome.
The KCCQ is a heart failure disease-specific quality of life measure encompassing domains of physical limitation, HF symptoms, quality of life, and social limitation scored on a scale of 0-100 with higher scores indicating better health status.
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Month 6
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Dalane W Kitzman, MD, Wake Forest University Health Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00087718
- R01AG078153 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Heart Failure With Preserved Ejection Fraction
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University of SienaEuropean Association of Cardiovascular ImagingActive, not recruitingHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection Fraction | Heart Failure With Mid Range Ejection FractionSpain, Greece, Turkey, Portugal, Australia, Belgium, Italy, Mexico, Netherlands, North Macedonia, Romania, Tunisia
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Istituti Clinici Scientifici Maugeri SpARecruitingHeart Failure With Preserved Ejection Fraction | Heart Failure With Midrange Ejection FractionItaly
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Milton S. Hershey Medical CenterWithdrawnHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection FractionUnited States
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Board of Trustees of Illinois State UniversityUniversity of Colorado, Denver; Abbott; University of North Carolina, Greensboro and other collaboratorsRecruitingHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection FractionUnited States
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Milton S. Hershey Medical CenterCompletedHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection FractionUnited States
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Zhijun SunEnrolling by invitationHeart Failure | Heart Failure With Preserved Ejection Fraction | Heart Failure With Mid Range Ejection FractionChina
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Corvia MedicalWithdrawnHeart Failure With Preserved Ejection Fraction | Heart Failure With Mid Range Ejection Fraction
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Occlutech International ABActive, not recruitingHeart Failure With Preserved Ejection Fraction (HFpEF) | Heart Failure With Reduced Ejection Fraction (HFrEF)United States
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Yale UniversityRecruitingHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection Fraction | Heart Failure NYHA Class IVUnited States
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Oslo Metropolitan UniversitySophies Minde Foundation; UniCare Bakke ASCompleted
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University of East AngliaCompleted
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Simon Fraser UniversityCompletedObesity | Cardiovascular Disease | DyslipidemiaCanada
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