NCT06312748 Novel Approaches for Improving Vascular Function in Veterans With HFpEF
| NCT ID | NCT06312748 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | VA Office of Research and Development |
| Condition | Heart Failure With Preserved Ejection Fraction |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2021-05-19 |
| Primary Completion | 2028-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 90 participants in total. It began in 2021-05-19 with a primary completion date of 2028-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
David W. Wray, PhD
PRINCIPAL INVESTIGATOR
VA Salt Lake City Health Care System, Salt Lake City, UT
Frequently Asked Questions
Who can join the NCT06312748 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure With Preserved Ejection Fraction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06312748 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06312748 currently recruiting?
Yes, NCT06312748 is actively recruiting participants. Contact the research team at David.Wray2@va.gov for enrollment information.
Where is the NCT06312748 trial being conducted?
This trial is being conducted at Salt Lake City, United States.
Who is sponsoring the NCT06312748 clinical trial?
NCT06312748 is sponsored by VA Office of Research and Development. The principal investigator is David W. Wray, PhD at VA Salt Lake City Health Care System, Salt Lake City, UT. The trial plans to enroll 90 participants.
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