Recruiting PHASE1 Heart Failure With Preserved Ejection Fraction

New treatment option for Heart Failure With Preserved Ejection Fraction

Official title Novel Approaches for Improving Vascular Function in Veterans With HFpEF

ClinicalTrials.gov ID: NCT06312748

What this study is testing

What is L-Citrulline?

L-Citrulline is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for heart failure with preserved ejection fraction.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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).
  • Phase 1: an early, usually small safety study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • 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...

You likely can't join if

  • 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.
See the full eligibility criteria
Who can join
  • 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...
What rules you out
  • 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.

The study team makes the final eligibility decision.

Where it's taking place

  • Salt Lake City, Utah, United States

Compensation & support

Compensation mentioned.

ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.

Questions & answers

Do participants get paid in this trial?

This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Salt Lake City, Utah, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.