Tailored Exercise Training Study Among Adults With HFpEF (TEXPEF)

The University of Texas System (UT)

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Diabetic Cardiomyopathies; HFpEF - Heart Failure With Preserved Ejection Fraction

Treatments: Drug: Weight loss; Behavioral: Resistance training; Behavioral: Moderate-intensity continuous training (MCT)

Study type: Interventional

Funder types: Other

Identifiers

NCT07223242

STU-2024-0592

Details and patient eligibility

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.

Full description

Heart failure (HF) portends substantial morbidity, mortality, and health care costs in the United States and the prevalence of heart failure with preserved ejection fraction (HFpEF) relative to HF with reduced ejection fraction (HFrEF) has been increasing. HFpEF is associated with a high morbidity and mortality burden. There are limited pharmacological options available for the treatment of HFpEF. It is now recognized as a systemic, multi-organ, geriatric syndrome, with exercise intolerance (EI) and functional impairment as the key clinical manifestations. 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 the effects of four different lifestyle interventions on exercise capacity.

The study will be carried out in two phases. In Phase I, 120 participants will undergo three months of home-based moderate-intensity continuous training (MCT), using tailored exercise videos on a mobile or tablet. Participants will also have weekly virtual meetings with a coach to discuss their progress. This will be followed by 3 months of no intervention, to assess the effects of detraining.

In Phase II (at the 6-month mark), 100 participants will be randomized to one of four extended training strategies for 3 months -(i) MCT alone; (ii) MCT plus resistance training; (iii) MCT plus weight loss, or (iv) MCT plus resistance training and weight loss.

The co-primary outcomes are (1) peak VO2, and (2) short physical performance battery score. In addition, participants will undergo CT chest/abdomen/pelvis at 3 months and 6 months to assess change in skeletal muscle composition with MCT

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 4 patient groups

Moderate-intensity continuous training (MCT)

Active Comparator group

Description:

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

Treatment:

Behavioral: Moderate-intensity continuous training (MCT)

Moderate-intensity continuous training + weight loss

Experimental group

Description:

Tailored moderate-intensity exercise training videos with weekly virtual meetings with a coach + initiation/intensification of pharmacological weight loss

Treatment:

Behavioral: Moderate-intensity continuous training (MCT)

Drug: Weight loss

Moderate-intensity continuous training + resistance training

Experimental group

Description:

Tailored moderate-intensity exercise training videos with weekly virtual meetings with a coach + tailored resistance training videos

Treatment:

Behavioral: Resistance training

Behavioral: Moderate-intensity continuous training (MCT)

Moderate-intensity continuous training + resistance training + weight loss

Experimental group

Description:

Tailored moderate-intensity exercise training videos with weekly virtual meetings with a coach + tailored resistance training videos + initiation/intensification of pharmacological weight loss

Treatment:

Behavioral: Resistance training

Behavioral: Moderate-intensity continuous training (MCT)

Drug: Weight loss