Improving Vascular Function in Veterans with Heart Failure
Official title: Novel Approaches for Improving Vascular Function in Veterans With HFpEF
Run by VA Office of Research and Development · NCT06312748 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Salt Lake City, Utah) |
| Status | Recruiting |
| Started | May 19, 2021 |
| Main results expected | September 30, 2028 |
| Study ends | September 30, 2030 |
| Registry record updated | April 23, 2026 |
| Trial ID | NCT06312748 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Remote rehabilitation for HFpEF patients using telerehabilitation
A home-based telerehabilitation program is being tested to see if it is safe and helpful for people with heart failure with preserved ejection fraction.
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EDG-15400 in adults with HFpEF: a phase 2 study
This phase 2 study tests different doses of EDG-15400 against placebo in adults with HFpEF to see if it is safe and tolerable.
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Incretin therapy with tirzepatide for obesity-related HFpEF
A 15-month study will test whether tirzepatide helps people with obesity and HFpEF by reducing plasma volume.
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Boosted exercise with group coaching for HFpEF
This trial tests a blended, guided exercise program with group coaching and remote monitoring to see if it helps older adults with HFpEF improve activity and health at a lower cost.
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Exercise cardiac MRI for heart failure with preserved ejection fraction
This study will try low-field exercise cardiac MRI to see if it can diagnose, describe, and predict risk in people with HFpEF compared with those who have non-cardiac breathlessness and healthy volunteers.
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HRS-1893 for heart failure with preserved ejection fraction
This trial will test whether HRS-1893 is safe and tolerable in adults aged 40 and older who have heart failure with preserved ejection fraction.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.