Tailored Exercise Training Study Among Adults With HFpEF

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Texas
University of Texas Southwestern Medical Center
RECRUITING
Dallas
Time Frame
Start Date: 2025-02-18
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 120
Treatments
Active_comparator: Moderate-intensity continuous training (MCT)
Tailored moderate-intensity exercise training video with weekly virtual meetings with a coach
Experimental: Moderate-intensity continuous training + weight loss
Tailored moderate-intensity exercise training videos with weekly virtual meetings with a coach + initiation/intensification of pharmacological weight loss
Experimental: Moderate-intensity continuous training + resistance training
Tailored moderate-intensity exercise training videos with weekly virtual meetings with a coach + tailored resistance training videos
Experimental: Moderate-intensity continuous training + resistance training + weight loss
Tailored moderate-intensity exercise training videos with weekly virtual meetings with a coach + tailored resistance training videos + initiation/intensification of pharmacological weight loss
Sponsors
Leads: University of Texas Southwestern Medical Center

This content was sourced from clinicaltrials.gov