Novel Approaches for Improving Vascular Function in Veterans With HFpEF
Recruiting · NCT06312748 · Interventional (participants receive a specific treatment) · Lead sponsor: VA Office of Research and Development
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed across 1 US state.
- VA Salt Lake City Health Care System, Salt Lake City, UT - Salt Lake City, Utah, United States