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Home-based Cardiac Rehabilitation in Heart Failure

StatusRecruiting
PhasePhase 3
Started2025-08-15
View on ClinicalTrials.gov ↗

Amendment history

2026-05-29
Study Status, Eligibility, Contacts/Locations v10
Eligibility criteria-74 characters
Inclusion Criteria: Adults aged 18 years or older History of hospitalization for acute heart failure withwithin ejectionthe fractionlast ≥12 35%months Ability to participate in telemedicine visits Access to sma [...] me-based cardiac rehabilitation program Exclusion Criteria: Heart failure with reduced ejection fraction (ejection fraction < 35%) Inability to participate in physical exercise or cardiac reh [...]
Study sitesdetails revised at 1 of 2 sites
2025-08-15
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v9
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-08-01→confirmed 2025-08-15
2025-07-08
Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility v8
PhaseNot applicable→Phase 3
Primary completion date2026-07-01→2028-12-01
Completion date2026-12-01→2028-12-01
Start date2025-06-22→2025-08-01
Enrollment target100→332
Study arms1→2
InterventionsMovn app (Device)→Accelerometer (Device), Movn app (Device)
Eligibility criteria+340 characters
Inclusion Criteria: AgeAdults more thanaged 18 years or older NYHAHistory classof II,hospitalization IIIfor symptomsacute 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: NeedHeart forfailure inotropeswith reduced ejection fraction (ejection fraction < 35%) Inability to participate in physical exercise or cardiac indexrehabilitation < 2.2 L/min/m2 planned revascularization within 3o days pla [...] [...]
Secondary endpoints2 to 5 entries
EnrollmentPhysical rateActivity Level LossGeneral toHealth-Related followQuality upof Life Implementation Outcomes Depressive Symptoms Anxiety Symptoms
Primary endpoints2 to 1 entries
PhysicalComposite activityHierarchical levels Quality of life using KCCQ scoreEndpoint
Study description+2,011 characters
We propose a pilot trial examining the effectiveness of a mHealth-based home CR program using a telemedicine platform for the identification, recruitment, and retention of an underserved rural population with HFrEF. This will be a non-randomized pre-post design comparing a mHealth home CR program to [...] Background and Significance: Rural communities in the United States experience a disproportionate burden of cardiovascular disease and associated adverse outcomes, with recent epidemiological data demonstrating a widening mortality gap compared to urban populations. These disparities are particularl [...]
Study title+1 characters
TelemedicineHome-based Cardiac Rehabilitation in Rural Patients With Heart Failure
2025-06-05
Study Status v7
Start date2025-05-15→2025-06-22
2025-03-27
Study Status v6
Primary completion date2025-07-01→2026-07-01
Completion date2025-12-01→2026-12-01
Start date2025-03-15→2025-05-15
Show 5 earlier versions
2025-03-24
Study Status v5
Start date2025-02-15→2025-03-15
2025-01-27
Study Status v4
Start date2025-01-15→2025-02-15
2024-12-05
Study Status v3
Start date2024-11-15→2025-01-15
2024-10-04
Study Status v2
Primary completion date2024-12-01→2025-07-01
Completion date2024-12-01→2025-12-01
Start date2024-09-01→2024-11-15
2024-07-30
Study Status v1
Start date2024-07-01→2024-09-01
2024-03-31
Original filing
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.
Trial Details
NCT Number NCT06349941
Lead Sponsor University of Texas Southwestern Medical Center
Conditions Heart Failure
Enrollment 332 participants
Start Date 2025-08-15
Primary Completion 2028-12-01 (estimated)
Study Completion 2028-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-02