RightFit
RecruitingPhase 1

Novel Approaches for Improving Vascular Function in Veterans With HFpEF

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests L-citrulline, tetrahydrobiopterin (BH4), and atorvastatin in Veterans with heart failure with preserved ejection fraction (HFpEF). In HFpEF, the heart still pumps out a normal share of blood. The study looks at how these treatments affect physical ability and how well blood vessels work.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older and able to give written consent to join.
  • Have heart failure in NYHA class I, II, or III—a rating based on symptoms during activity.
  • Have an ejection fraction above 50%, meaning the heart’s main pumping chamber pumps out more than half its blood with each beat.
  • At Visit 1, have a BNP blood level of at least 150 pg/mL or NT-proBNP of at least 600 pg/mL. Or, have BNP of at least 100 pg/mL or NT-proBNP of at least 400 pg/mL, plus a hospital stay for heart failure in the past 12 months. These blood tests measure signs of heart strain.

Who can't join

  • Have had an allergy or strong reaction to any fat-soluble statin, a type of cholesterol medicine.
  • Previously had an ejection fraction below 50%.
  • Have NYHA class IV heart failure, with symptoms even at rest.
  • Have HFpEF caused by a major heart valve problem that has not been corrected.
  • Have active liver disease or liver enzyme blood tests that stay high without a known reason.
  • Are a woman who is pregnant or may become pregnant.
  • Currently take antioxidants, nitrates, PDE-5 inhibitors, or statins. These include certain supplements and medicines for chest pain, erection problems, or high cholesterol.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

UT