Tailored exercise training for adults with HFpEF

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2/3 interventional study delivers home-based moderate-intensity continuous training (MCT) through tailored exercise videos on mobile devices with weekly virtual support and measures effects on exercise capacity and skeletal muscle composition. In Phase I, 120 participants undergo three months of remote MCT with in-person baseline and follow-up testing including CPET and physical performance measures. Participants who meet randomization criteria (including BMI ≥28) enter Phase II to compare four lifestyle interventions such as resistance training and weight-loss programs for their effects on peak VO2, SPPB, muscle composition, and quality of life. The design emphasizes remote delivery to overcome logistical and cost barriers of supervised exercise while retaining key in-person assessments at the study center.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Texas Southwestern Medical Center
  Dallas, Texas, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.