Clinical trial

Tailored Exercise Training Study Among Adults With HFpEF

Recruiting now · Phase 2, Phase 3 · 1 countries · Registry ID NCT07223242

Recruiting nowPhase 2, Phase 3Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionHFpEF - Heart Failure With Preserved Ejection Fraction, Diabetic Cardiomyopathies

Full registry criteria

Inclusion Criteria: 1. Age\>= 18 yrs 2. LVEF (Left Ventricular Ejection Fraction) \>= 50% 3. History of HFpEF or at risk of HFpEF 1. HFpEF diagnosis based on:- -HF hospitalization within 12 months- * NT-proBNP \>360 pg/mL 2. Risk of HFpEF based on:- * \>2 risk factors (h/o diabetes, hypertension, obesity, physical inactivity by self-report) 4. SPPB \< 10 or VO2\<60th percentile 5. BMI \>=28 (for randomization in phase II) 6. Able to use cell phone and mobile application Exclusion Criteria: 1. Hospitalization 1 month prior to baseline visit 2. History of recurrent falls 3. eGFR (Estimated Glomerular Filtration Rate) \<20ml/min/1.73m 4. Active changes in HF therapies over 2 weeks prior to baseline visit 5. Inability participate in exercise training therapy 6. Inability to perform CPET (Cardiopulmonary Exercise Testing) testing 7. Severe left side valvular heart disease 8. End stage pulmonary disease, requiring continuous supplemental oxygen 9. Major surgery within 3 months of screening or major elective surgery during the duration of the study. 10. Unstable weight defined by \>5% change in body weight in last 30 days before first study visit. 11. Pregnancy

Treatments and study arms

Moderate-intensity continuous training (MCT)

Behavioral

Tailored moderate-intensity exercise training video with weekly virtual meetings with a coach

Resistance training

Behavioral

Resistance training videos assigned to patient

Weight loss

Drug

Initiation/intensification of weight loss medications, such as semaglutide or tirzepatide

Primary outcomes

Peak Exercise Oxygen Uptake (VO2peak)Baseline, 3months, 6months, and 9months

VO2peak indexed to body weight (mL/kg/min) will be the co-primary outcome for the trial. VO2peak is a gold-standard measure of aerobic exercise capacity and will be measured by maximal exercise test using a previously established ergometer protocol

Short Physical Performance Battery (SPPB)Baseline, 3months, 6months, and 9months

SPPB will be a co-primary outcome for the trial. Score ranges from 0 to 12, with 0 indicating the worst performance and 12 indicating the best.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of Texas Southwestern Medical Center🇺🇸 Dallas, Texas, United States
Ambarish Pandey, MDContact