Improving Vascular Function in Veterans with Heart Failure
Novel Approaches for Improving Vascular Function in Veterans With HFpEF
This study is testing whether a combination of L-Citrulline, BH4, and atorvastatin can help improve blood flow and physical ability in Veterans with heart failure.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Salt Lake City, Utah) |
| Trial ID | NCT06312748 on ClinicalTrials.gov |
What this trial studies
This project evaluates the effects of L-Citrulline, tetrahydrobiopterin (BH4), and atorvastatin on physical capacity and vascular function in Veterans suffering from heart failure with preserved ejection fraction (HFpEF). The study aims to address the rising hospital admission rates among Veterans with HFpEF by exploring alternative therapeutic approaches that target vascular dysfunction and chronic inflammation. By assessing the impact of these interventions, the research seeks to improve exercise tolerance and overall health outcomes for this patient population.
Who should consider this trial
Good fit: Ideal candidates include Veterans aged 18 and older with HFpEF, specifically those with a left ventricular ejection fraction greater than 50% and elevated plasma BNP levels.
Not a fit: Patients with significant uncorrected primary valvular disease or those with a history of hypersensitivity to statins may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved physical capacity and reduced hospital readmissions for Veterans with HFpEF.
How similar studies have performed: While there have been studies exploring vascular function in heart failure, this approach using L-Citrulline and BH4 in Veterans with HFpEF is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years or older and able to give written informed consent. * New York Heart Association (NYHA) functional class I, II, or III. * Left Ventricular Ejection Fraction (LVEF) \> 50%. * Plasma Brain Natriuretic Peptide (BNP) equal to or greater than 150 pg/mL or NT-proBNP equal to or greater than 600 pg/mL at Visit 1, or a BNP equal to or great than 100 pg/mL (or NT-proBNP equal to or greater than 400 pg/mL) and a hospitalization for heart failure within the last 12 months. Exclusion Criteria: * History of hypersensitivity or allergy to any lipophilic statin. * Prior EF \<50%. * NYHA Class IV. * Patients with HFpEF secondary to significant uncorrected primary valvular disease. * Active liver disease or unexplained persistent elevations in serum transaminase. * Women who are pregnant or may become pregnant. * Patients currently treated with antioxidants, nitrates, PDE-5 inhibitors, or statins.
Where this trial is running
Salt Lake City, Utah
- VA Salt Lake City Health Care System, Salt Lake City, UT — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Principal investigator: David W. Wray, PhD — VA Salt Lake City Health Care System, Salt Lake City, UT
- Study coordinator: David W Wray, PhD
- Email: David.Wray2@va.gov
- Phone: (801) 582-1565
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.