RECRUITINGPhase 2 / Phase 3INTERVENTIONAL

Tailored Exercise Training Study Among Adults With HFpEF

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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 Being Tested

BEHAVIORAL

Moderate-intensity continuous training (MCT)

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

BEHAVIORAL

Resistance training

Resistance training videos assigned to patient

DRUG

Weight loss

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

Locations (1)

University of Texas Southwestern Medical Center

Dallas, Texas, United States