Novel Approaches for Improving Vascular Function in Veterans With HFpEF

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Mar 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying new ways to improve blood vessel function and physical ability in veterans who have a type of heart failure called heart failure with preserved ejection fraction (HFpEF). The trial will explore how three different treatments—L-Citrulline, tetrahydrobiopterin (BH4), and atorvastatin—might help these patients feel better and improve their overall health.

To join the study, participants need to be at least 18 years old and able to provide written consent. They should have a certain level of heart function and have experienced some symptoms related to heart failure, but not be severely affected (classified as NYHA functional class I, II, or III). Participants can expect to receive one of the treatments and will be monitored throughout the study to see how they respond. It’s important to note that some people may not be eligible to participate, especially if they have specific health issues or are taking certain medications. This trial is currently recruiting, and all veterans regardless of gender are welcome to apply.

Gender

ALL

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.