← Trials/Trial dossier/NCT07223242

TEXPEF

RecruitingPhase 2, PHASE3

Tailored Exercise Training Study Among Adults With HFpEF

Lead sponsor

University of Texas Southwestern Medical Center

Assets

Semaglutide / Tirzepatide

Listed sites

Recruiting sites

Enrollment

120

estimated

Study population

Heart failure, Obesity / overweight

Key I/E criteria

•BMI ≥28•EF ≥50%

Primary endpoints

•Peak Exercise Oxygen Uptake (VO2peak)•Short Physical Performance Battery (SPPB)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07223242

Org study IDSTU-2024-0592

Timeline

Milestones

Study start2025-02-18actual

Study first posted2025-10-31actual

Last update posted2025-10-31actual

Primary completion2026-12-30estimated

Study completion2026-12-30estimated

Assets

Investigational agents

Semaglutide Tirzepatide

Study populations

Who this study enrolls

Heart failureObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (22)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Heart failure

Weight & body composition

Patient-reported / QoL

Other clinical outcomes

Other (unclassified)

Cardiometabolic biomarkers

Weight & body composition

6 endpoints

Secondary/protocol endpoint/low confidence

Intramyocellular fat

Time frame:Baseline, 3months, 6months, and 9months

change from baseline, improvement

Secondary/protocol endpoint

Intermuscular Adipose Tissue (IMAT)

Time frame:Baseline, 3months, 6months, and 9months

change from baseline, improvement

Secondary/protocol endpoint

Subcutaneous adiposity deposits

Time frame:Baseline, 3months, 6months, and 9months

Subcutaneous fat, change

change from baseline, improvement

Secondary/protocol endpoint

Visceral Adiposity Deposits

Time frame:Baseline, 3months, 6months, and 9months

Visceral fat, change

change from baseline, improvement

Secondary/protocol endpoint

Pericardial Adiposity Deposits

Time frame:Baseline, 3months, 6months, and 9months

Visceral fat, change

change from baseline, improvement

Secondary/protocol endpoint

Lower Body Adiposity Deposits

Time frame:Baseline, 3months, 6months, and 9months

change from baseline, improvement

Heart failure

8 endpoints

Primary/protocol endpoint

Peak Exercise Oxygen Uptake (VO2peak)

Time frame:Baseline, 3months, 6months, and 9months

descriptive

Secondary/protocol endpoint

Kansas City Cardiomyopathy Questionnaire 12 (KCCQ-12)

Time frame:Baseline, 3months, 6months, and 9months

KCCQ total score

change from baseline, improvement

Secondary/protocol endpoint

6 Minute Walk Distance (6MWD)

Time frame:Baseline, 3months, 6months, and 9months

6-minute walk distance

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Thirty Second Chair Test

Time frame:Baseline, 3months, 6months, and 9months

descriptive

Secondary/protocol endpoint/low confidence

Exercise cardiac output

Time frame:Baseline, 3months, 6months, and 9months

descriptive

Secondary/protocol endpoint

E/e': Ratio of early mitral inflow velocity (E) to early diastolic mitral annular velocity (e')

Time frame:Baseline, 3months, 6months, and 9months

ratio, improvement

Secondary/protocol endpoint/low confidence

Left ventricular global longitudinal strain (LV GLS)

Time frame:Baseline, 3months, 6months, and 9months

descriptive

Secondary/protocol endpoint

NT-proBNP

Time frame:Baseline, 3months, 6months, and 9months

NT-proBNP, change

change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint

Secondary/protocol endpoint/low confidence

High-sensitivity troponin I

Time frame:Baseline, 3months, 6months, and 9months

descriptive

Patient-reported / QoL

3 endpoints

Secondary/protocol endpoint

General Quality of Life - EQ-5D-5L

Time frame:Baseline, 3months, 6months, and 9months

EQ-5D index

change from baseline, improvement

Secondary/protocol endpoint

GAD 7 score

Time frame:Baseline, 3months, 6months, and 9months

change from baseline, improvement

Secondary/protocol endpoint

PHQ 9 score

Time frame:Baseline, 3months, 6months, and 9months

change from baseline, improvement

Other clinical outcomes

2 endpoints

Primary/protocol endpoint

Short Physical Performance Battery (SPPB)

Time frame:Baseline, 3months, 6months, and 9months

change from baseline, improvement

Secondary/protocol endpoint

Fried Frailty Phenotype

Time frame:Baseline, 3months, 6months, and 9months

descriptive, improvement

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Resting cardiac output

Time frame:Baseline, 3months, 6months, and 9months

descriptive

Secondary/protocol endpoint/low confidence

Left atrial reservoir strain

Time frame:Baseline, 3months, 6months, and 9months

change from baseline, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.