RecruitingPhase 1NCT06312748

Novel Approaches for Improving Vascular Function in Veterans With HFpEF

Sponsor

VA Office of Research and Development

Enrollment

90 participants

Start Date

May 19, 2021

Study Type

INTERVENTIONAL

Conditions

Inflammation Heart Failure With Preserved Ejection Fraction

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

Min Age: 18 Years

Inclusion Criteria4

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 Criteria7

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.