Personalized cardiac rehab for veterans with HFpEF
Precision Rehabilitation for Veterans With Heart Failure With Preserved Ejection Fraction (HFpEF)
This project will try a supervised 12-week monitored exercise program during cardiac rehabilitation to see if it improves fitness and heart function in veterans with HFpEF.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 4 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Columbia VA Health Care System Federal |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Columbia, South Carolina) |
| Trial ID | NCT07493915 on ClinicalTrials.gov |
What this trial studies
This observational feasibility project will enroll a small number of veterans to test whether a monitored, moderate continuous training program delivered three times weekly for 12 weeks can be carried out safely and produces measurable changes in cardiorespiratory fitness. Participants will undergo baseline testing including a cardiopulmonary exercise test (CPET), heart imaging, and two small blood draws, then complete supervised exercise sessions at the VA facility while investigators track VO2Peak, symptoms, quality of life, and cardiac structure and function. The initial enrollment of four patients is intended to refine the protocol, confirm the facility can support a larger trial, and check for any clear harms or promising signals. The study also aims to identify baseline features that predict who is most likely to respond to exercise.
Who should consider this trial
Good fit: Ideal candidates are veterans with NYHA class II or III symptoms, EF ≥50%, left ventricular hypertrophy, evidence of diastolic dysfunction, a history of hypertension, and medical clearance plus ability to participate in supervised exercise.
Not a fit: Patients with EF <50%, absence of LVH, significant LV dilation, segmental wall motion abnormalities, significant valvular or non-coronary heart disease, active non-cardiac conditions affecting the heart, or who cannot safely exercise are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, this approach could demonstrate that supervised moderate exercise increases cardiorespiratory fitness, reduces symptoms, and improves quality of life for veterans with HFpEF, informing larger trials and VA care programs.
How similar studies have performed: Small prior studies have suggested supervised exercise can improve VO2Peak in some HFpEF patients, but results have been mixed and no large definitive trial has yet confirmed a consistent benefit.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * New York Heart Association Class II or III HF symptoms * History of hypertension * EF≥50% * LVH confirmed by echocardiography, Cardiac CT, or Cardiac MR * Diastolic dysfunction which must include ≥2 of the following: 1. Average E/e'\>14 2. Septal e'\<7 cm/s or Lateral e' \<10 cm/s 3. TR velocity\> 2.8 m/s 4. LA computed volume index \>34 mL/M2 5. PCWP or LVEDP\>15 * Ability to participate in an exercise program as determined by a research, cardiology, or primary care provider Exclusion Criteria: * Ejection Fraction \< 50% * Absence of LVH * LV Dilation (LV end diastolic volume indexed to BSA \> 75 ml/m2) * Any Segmental wall motion abnormality * Acute ST segment elevation myocardial infarction (STEMI) * Significant valvular or other non-coronary heart disease * Any non-cardiac disease or condition that could influence myocardial function (e.g., collagen-vascular disease, history of cardiotoxic cancer chemotherapy, amyloid) * Anemia defined as Hgb \< 11.0 g/dl in males, 10 g/dl in females * Current accelerating angina, unstable angina, angina at rest, or NSTEMI within 3 months * Chronic pulmonary disease requiring home oxygen or steroid therapy * Significant non-CV organ disease: Chronic hepatic or renal disease (eGFR \< 25 mL/min/1.73m2) * Inability to provide informed consent * Inability to perform exercise
Where this trial is running
Columbia, South Carolina
- Columbia VA Health Care System — Columbia, South Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Kurt Barringhaus, MD, FACC, FSCAI — William Jennings Bryan Dorn VA Medical Center
- Study coordinator: Kurt Barringhaus, MD, FACC, FSCAI
- Email: kurt.barringhaus@va.gov
- Phone: 803-776-4000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.