Tailored Exercise Training Study Among Adults With HFpEF

NCT07223242 | Recruiting Phase 2 FDA Drug

• 1 other identifier: STU-2024-0592
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HFpEF - Heart Failure With Preserved Ejection Fraction; Diabetic Cardiomyopathies

Keywords

Diabetic cardiomyopathy; Remote exercise training; Weight loss; Rehab

Outcome Measures

Primary Outcomes (2)

• Peak Exercise Oxygen Uptake (VO2peak)

  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

  Baseline, 3months, 6months, and 9months

• Short Physical Performance Battery (SPPB)

  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.

  Baseline, 3months, 6months, and 9months

Secondary Outcomes (20)

• Kansas City Cardiomyopathy Questionnaire 12 (KCCQ-12)

  Baseline, 3months, 6months, and 9months

• 6 Minute Walk Distance (6MWD)

  Baseline, 3months, 6months, and 9months

• General Quality of Life - EQ-5D-5L

  Baseline, 3months, 6months, and 9months

• Thirty Second Chair Test

  Baseline, 3months, 6months, and 9months

• Fried Frailty Phenotype

  Baseline, 3months, 6months, and 9months

Study Arms (4)

Moderate-intensity continuous training (MCT)

ACTIVE COMPARATOR

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

Behavioral: Moderate-intensity continuous training (MCT)

Moderate-intensity continuous training + weight loss

EXPERIMENTAL

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

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

Moderate-intensity continuous training + resistance training

EXPERIMENTAL

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

Behavioral: Moderate-intensity continuous training (MCT); Behavioral: Resistance training

Moderate-intensity continuous training + resistance training + weight loss

EXPERIMENTAL

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

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

Interventions

Moderate-intensity continuous training (MCT) BEHAVIORAL

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

Moderate-intensity continuous training (MCT); Moderate-intensity continuous training + resistance training; Moderate-intensity continuous training + resistance training + weight loss; Moderate-intensity continuous training + weight loss

Resistance training BEHAVIORAL

Resistance training videos assigned to patient

Moderate-intensity continuous training + resistance training; Moderate-intensity continuous training + resistance training + weight loss

Weight loss DRUG

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

Moderate-intensity continuous training + resistance training + weight loss; Moderate-intensity continuous training + weight loss

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Hospitalization 1 month prior to baseline visit
• History of recurrent falls
• eGFR (Estimated Glomerular Filtration Rate) \<20ml/min/1.73m
• Active changes in HF therapies over 2 weeks prior to baseline visit
• Inability participate in exercise training therapy
• Inability to perform CPET (Cardiopulmonary Exercise Testing) testing
• Severe left side valvular heart disease
• End stage pulmonary disease, requiring continuous supplemental oxygen
• 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.
• Pregnancy

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75209, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Cardiomyopathies; Weight Loss

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: Participants will be randomized in a 1:1:1:1 fashion for phase 2

Study Record Dates

• First Submitted: October 6, 2025
• First Posted: October 31, 2025
• Study Start: February 18, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: October 31, 2025

Record last verified: 2025-10

Locations

US (1)