NCT06349941 Home-based Cardiac Rehabilitation in Heart Failure
| NCT ID | NCT06349941 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Texas Southwestern Medical Center |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 332 participants |
| Start Date | 2025-08-15 |
| Primary Completion | 2028-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 332 participants in total. It began in 2025-08-15 with a primary completion date of 2028-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * Adults aged 18 years or older * History of hospitalization for acute heart failure within the last 12 months * 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: * 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
Frequently Asked Questions
Who can join the NCT06349941 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06349941 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 332 participants.
Is NCT06349941 currently recruiting?
Yes, NCT06349941 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Texas Southwestern Medical Center to inquire about joining.
Where is the NCT06349941 trial being conducted?
This trial is being conducted at Dallas, United States, Dallas, United States.
Who is sponsoring the NCT06349941 clinical trial?
NCT06349941 is sponsored by University of Texas Southwestern Medical Center. The trial plans to enroll 332 participants.
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