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Taking people in United StatesPhase 2/3

Exercise and weight loss tested in adults with heart failure with preserved ejection fraction

Tests remote exercise training and lifestyle programs in adults with a heart-pumping condition called HFpEF.

Plain-language title generated from the registry record
Registry title: Tailored Exercise Training Study Among Adults With HFpEF

Key facts

Where
Dallas, United StatesSee the site
Phase
Phase 2/3

Where in United States

  • University of Texas Southwestern Medical CenterDallas, United StatesTaking people

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Trial details

Who runs it
University of Texas Southwestern Medical Center
Trial code
NCT07223242
Record updated
31 October 2025
Original description
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.Read full original descriptionShow less

Tailored Exercise Training Study Among Adults With HFpEF

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.

Inclusion: 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.

Exclusion: 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; History of recurrent falls; Severe left side valvular heart disease; End stage pulmonary disease, requiring continuous supplemental oxygen; eGFR (Estimated Glomerular Filtration Rate) <20ml/min/1.73m; Inability to perform CPET (Cardiopulmonary Exercise Testing) testing; Pregnancy.

ClinicalTrials.gov NCT07223242