Novel Approaches for Improving Vascular Function in Veterans With HFpEF
Recruiting now · Phase 1 · Has a placebo group
Conditions studied: Heart Failure With Preserved Ejection Fraction, Inflammation
In brief
This project will evaluate the impact of L-Citrulline, tetrahydrobiopterin (BH4), and atorvastatin administration on physical capacity and vascular function in Veterans with heart failure with preserved ejection fraction (HFpEF).
Key facts
- Study ID
- NCT06312748
- Run by
- VA Office of Research and Development
- People needed
- 90
- Starts
- 2021-05-19
- Expected to finish
- 2030-09-30
- Last updated by the study team
- 2026-04-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- VA Salt Lake City Health Care System, Salt Lake City, UT — Salt Lake City, Utah, United States (enrolling)
Full record on ClinicalTrials.gov
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