NCT05002075Completed
Efficacy of an m-Health Cardiac Rehabilitation Program in Heart Failure With Preserved Ejection Fraction
Efficacy of an m-Health Cardiac Rehabilitation Program in Heart Failure With Preserved Ejection Fraction: A Pilot Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 16 May 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 69 (actual)
- First submitted
- 28 Jul 2021
- Start date
- 20 Nov 2021
- Primary completion date
- 13 May 2024
- Lead sponsor
- University of Texas Southwestern Medical Center
- Diseases
- Heart failure
- NCT number
- NCT05002075
What you commit to
- Study type: Interventional
- Participants enrolled: 69
- From 20 Nov 2021 to the primary completion date, 13 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of cancer or end stage lung disease
- History of falls
Other
- Estimated glomerular filtration rate \< 45 mL/min/1.73 m2 as measured by the simplified MDRD formula
- Recent HF decompensation
- Inability to do exercise test
- Inability to provide written informed consent
Who the study is looking for
- Adults age\> 18 years
- HFpEF with left ventricular ejection fraction \>50%
- Clinically stable and no hospitalization in last 4 weeks
- Estimated glomerular filtration rate \> 45 mL/min/1.73 m2 as measured by the simplified MDRD formula
- Stable diuretic regimen
- SPPB \<10 or historical (within 12 months) or current Peak (measured or estimated) VO2 \<= 60% predicted value for age and gender.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UT Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.