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Recruiting Phase 1 NCT06312748

Novel Approaches for Improving Vascular Function in Veterans With HFpEF

Trial Parameters

Condition Heart Failure With Preserved Ejection Fraction
Sponsor VA Office of Research and Development
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 90
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2021-05-19
Completion 2028-09-30
Interventions
L-CitrullinePlacebo for L-CitrullineBH4

Brief Summary

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).

Eligibility 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.

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