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NCT05002075 · ClinicalTrials.gov registry record · NA

Efficacy of an m-Health Cardiac Rehabilitation Program in Heart Failure With Preserved Ejection Fraction

A NA study, sponsored by University of Texas Southwestern Medical Center.

Completed
Registry status
NA
Development phase
69
Enrollment target

NCT05002075: Completed NA study, sponsored by University of Texas Southwestern Medical Center.

NCT05002075 is a NA study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 69 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05002075, a NA study, has completed, sponsored by University of Texas Southwestern Medical Center.

COMPLETED
Registry status
NA
Development phase
69 participants
Enrollment target

Study Summary

Heart failure (HF) portends substantial morbidity, mortality, and health care costs in the United States and the prevalence of heart failure with preserved ejection fraction (HFpEF) relative to HF with reduced ejection fraction (HFrEF) has been increasing. HFpEF is associated with a high morbidity and mortality burden and is projected to be the predominant subtype of HF in the near future. While multiple therapies have proven efficacious for patients with HFrEF, no pharmacological agents have demonstrably been shown to improve outcomes in HFpEF, highlighting the need for novel approaches to HFpEF treatment. Exercise intolerance (EI) is the cardinal symptom of HFpEF, which manifests as dyspnea and fatigue. EI leads to functional deconditioning and reduced quality of life (QOL), both of which elevate risk of death and hospitalization in patients with HFpEF. Supervised exercised training is associated with improvements in exercise capacity and QOL in adults with HFpEF. However, supervised exercise has not been widely utilized for the treatment of HFpEF due to logistical and fiscal barriers. Home-based exercise using an m-Health platform is an alternative to supervised exercise that can deliver clinician prescribed exercise interventions and wellness education though monitoring and care coordination. The goal of this study is to evaluate the feasibility and efficacy of a patient specific progressive home-based cardiac rehabilitation program leveraging the technology of the m-Health program in improving functional status, exercise capacity, and QOL in patients with HFpEF.

Primary Outcome

SPPB score is a well-validated measure of physical function using 3 components: 4-m gait speed, time to complete 5 chair rises, and standing balance. Each component is scored on a 0-4 scale and summed for an overall score range of 0-12.

Interventions

  • OTHER m-health cardiac rehabilitation

Trial Details

FieldValue
Enrollment Target 69 participants
Start Date 2021-11-20
Est. Completion 2024-05-13
Phase NA

What the finished NCT05002075 record still lists

NCT05002075 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 1 intervention - of which m-health cardiac rehabilitation is the first listed.

NCT05002075 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05002075 about?

NCT05002075 is a clinical study titled "Efficacy of an m-Health Cardiac Rehabilitation Program in Heart Failure With Preserved Ejection Fraction". Heart failure (HF) portends substantial morbidity, mortality, and health care costs in the United States and the prevalence of heart failure with preserved ejection fraction (HFpEF) relative to HF with reduced ejection fraction (HFrEF) has been increasing. HFpEF is associated with a high morbidity a...

What is the current status of trial NCT05002075?

This trial is currently completed. It is a NA study. The enrollment target is 69 participants. The study started on 2021-11-20. Estimated completion is 2024-05-13.

What interventions are being tested in trial NCT05002075?

The interventions under investigation include: m-health cardiac rehabilitation (OTHER).

Who is sponsoring clinical trial NCT05002075?

This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05002075's enrollment target sits among peer trials

69 1133rd of 2000 higher than 868 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05002075, the US trial registry maintained by the National Library of Medicine. NCT05002075 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.