NCT07223242RecruitingPhase 2/3
Tailored Exercise Training Study Among Adults With HFpEF
Source: ClinicalTrials.gov · Last updated 31 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Heart failure with preserved ejection fraction (HFpEF) is associated with a high morbidity and mortality burden. There are limited pharmacological options available for the treatment of HFpEF. 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. This study will investigate the effects of a remote exercise training intervention on exercise capacity and skeletal muscle composition in patients with HFpEF, or those at risk for it. In addition, it will compare four different lifestyle interventions for their effects on exercise capacity.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 6 Oct 2025
- Start date
- 18 Feb 2025
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- University of Texas Southwestern Medical Center
- Diseases
- Heart failure
- NCT number
- NCT07223242
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 120
- From 18 Feb 2025 to the primary completion date, 30 Dec 2026
- 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.
Prior treatment
- Hospitalization 1 month prior to baseline visit
- Active changes in HF therapies over 2 weeks prior to baseline visit
- Inability participate in exercise training therapy
- Major surgery within 3 months of screening or major elective surgery during the duration of the study.
- Unstable weight defined by \>5% change in body weight in last 30 days before first study visit.
Other illness
- History of recurrent falls
- Severe left side valvular heart disease
- End stage pulmonary disease, requiring continuous supplemental oxygen
Lab values
- eGFR (Estimated Glomerular Filtration Rate) \<20ml/min/1.73m
Other
- Inability to perform CPET (Cardiopulmonary Exercise Testing) testing
- Pregnancy
Who the study is looking for
- Age\>= 18 yrs
- LVEF (Left Ventricular Ejection Fraction) \>= 50%
- History of HFpEF or at risk of HFpEF
- HFpEF diagnosis based on:- -HF hospitalization within 12 months-
- NT-proBNP \>360 pg/mL
- Risk of HFpEF based on:-
- \>2 risk factors (h/o diabetes, hypertension, obesity, physical inactivity by self-report)
- SPPB \< 10 or VO2\<60th percentile
- BMI \>=28 (for randomization in phase II)
- Able to use cell phone and mobile application
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 |
|---|---|---|---|
| University of Texas Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.