Novel Approaches for Improving Vascular Function in Veterans With HFpEF
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- L-Citrulline
- Placebo for L-Citrulline
- BH4
- Placebo for BH4
- Atorvastatin
- Placebo for Atorvastatin
Treatment groups
90 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
VA Office of Research and Development
Lead sponsor
University of Utah
Collaborator
Source ClinicalTrials.gov