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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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 ejection fraction (HFpEF), which is nearly unique to older persons, and for which there are few treatment options.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

• 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

Locations
United States
North Carolina
Atrium Health Wake Forest Baptist
RECRUITING
Winston-salem
Contact Information
Primary
Michael B Nelson, MS
mbnelson@wakehealth.edu
336-716-6789
Time Frame
Start Date: 2023-02-16
Estimated Completion Date: 2028-01
Participants
Target number of participants: 880
Treatments
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.
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.
Sponsors
Collaborators: National Institute on Aging (NIA)
Leads: Wake Forest University Health Sciences

This content was sourced from clinicaltrials.gov