Status:
RECRUITING
Tailored Exercise Training Study Among Adults With HFpEF
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
HFpEF - Heart Failure With Preserved Ejection Fraction
Diabetic Cardiomyopathies
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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. Exercis...
Detailed 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 wit...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT07223242
Start Date
February 18 2025
End Date
December 30 2026
Last Update
October 31 2025
Active Locations (1)
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1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75209