Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06349941

Home-based Cardiac Rehabilitation in Heart Failure

Led by University of Texas Southwestern Medical Center · Updated on 2025-08-21

332

Participants Needed

2

Research Sites

172 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study evaluates a mobile health (mHealth) home-based cardiac rehabilitation program for patients with heart failure. We will stratify randomization between rural and urban populations, with the goal to assess implementation of cardiac rehabilitation across these two geographic areas. . The study will randomize 332 patients with heart failure (ejection fraction ≥35%) who are not eligible for center-based rehabilitation to either a 12-week mHealth cardiac rehabilitation program or an attention control group, with outcomes measured over 6 months using a composite endpoint of mortality, hospitalizations, and quality of life. We will then assess the implementation of the intervention.

CONDITIONS

Official Title

Home-based Cardiac Rehabilitation in Heart Failure

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • History of hospitalization for acute heart failure with ejection fraction 65 35%
  • Ability to participate in telemedicine visits
  • Access to smartphone or device capable of running the mHealth application
  • Willingness to participate in home-based cardiac rehabilitation program
Not Eligible

You will not qualify if you...

  • Heart failure with reduced ejection fraction (ejection fraction < 35%)
  • Inability to participate in physical exercise or cardiac rehabilitation due to medical contraindications
  • Inability to provide informed consent
  • Lack of access to required technology (smartphone, internet connectivity)
  • Life expectancy less than 6 months
  • Inability to participate in telemedicine visits or remote monitoring
  • Current participation in another cardiac rehabilitation program

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75209

Actively Recruiting

2

Baylor Scott and White Health System

Dallas, Texas, United States, 75246

Not Yet Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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