Novel Approaches for Improving Vascular Function in Veterans With HFpEF (NCT06312748) | Clinical Trial Compass
RecruitingPhase 1
Novel Approaches for Improving Vascular Function in Veterans With HFpEF
United States90 participantsStarted 2021-05-19
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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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.