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Home-based Cardiac Rehabilitation in Heart Failure

RECRUITINGPhase 3Sponsored by University of Texas Southwestern Medical Center
Actively Recruiting
PhasePhase 3
SponsorUniversity of Texas Southwestern Medical Center
Started2025-08-15
Est. completion2028-12-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations2 sites

Summary

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* Adults aged 18 years or older
* History of hospitalization for acute heart failure with ejection fraction ≥ 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

Exclusion Criteria:

* 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

Conditions2

Heart DiseaseHeart Failure

Locations2 sites

University of Texas Southwestern Medical Center
Dallas, Texas, 75209
Ambarish Pandey, MD214-645-9868ambarish.pandey@utsouthwestern.edu
Baylor Scott and White Health System
Dallas, Texas, 75246
Neil Keshvani, MD214-384-9004neil.keshvani@bswhealth.org

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