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Statins

L-Citrulline + BH4 + Atorvastatin for Heart Failure

Phase 1

Recruiting

Research Sponsored by D. Walter Wray

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, day 90

Summary

This trial will study how L-Citrulline, tetrahydrobiopterin (BH4), and atorvastatin affect the physical ability and blood vessel function in Veterans with heart failure

Who is the study for?

This trial is for veterans with heart failure where the heart's lower chambers are still pumping well (HFpEF). Participants should have signs of inflammation or diagnosed heart failure. Specific eligibility details aren't provided, but typically, participants must be in stable health and meet certain medical criteria.

What is being tested?

The study tests if L-Citrulline, BH4 (tetrahydrobiopterin), or atorvastatin can improve how far veterans with HFpEF can walk and their blood vessel function. Each participant will receive one treatment followed by a placebo in different periods to compare effects.

What are the potential side effects?

Possible side effects may include digestive discomfort from L-Citrulline, headaches or gastrointestinal issues from BH4, and muscle pain or weakness from atorvastatin. Placebos generally have no active ingredients but can cause perceived side effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, day 90

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, day 90

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, day 90 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Flow-mediated dilation (FMD)

Secondary study objectives

Passive Limb Movement (PLM)

Trial Design

6Treatment groups

Experimental Treatment

Group I: Placebo, Then L-CitrullineExperimental Treatment2 Interventions

Participants will receive a 90-day supply of Placebo and perform baseline assessments of resting arterial blood pressure, ECT, arterial elasticity/pulse contour analysis, flow-mediated vasodilation and passive limb movement procedures. Participants will return to the laboratory for up to 5 additional study visits (days 10, 20, 30, 60, and 90) and repeat the experimental protocol. After a two-week washout period, participants will receive a 90-day supply of L-Citrulline and perform baseline and follow-up assessments as above.

Group II: Placebo, Then BH4Experimental Treatment2 Interventions

Participants will receive a 90-day supply of Placebo and perform baseline assessments of resting arterial blood pressure, ECT, arterial elasticity/pulse contour analysis, flow-mediated vasodilation and passive limb movement procedures. Participants will return to the laboratory for up to 5 additional study visits (days 10, 20, 30, 60, and 90) and repeat the experimental protocol. After a two-week washout period, participants will receive a 90-day supply of BH4 and perform baseline and follow-up assessments as above.

Group III: Placebo, Then AtorvastatinExperimental Treatment2 Interventions

Participants will receive a 90-day supply of Placebo and perform baseline assessments of resting arterial blood pressure, ECT, arterial elasticity/pulse contour analysis, flow-mediated vasodilation and passive limb movement procedures. Participants will return to the laboratory for up to 5 additional study visits (days 10, 20, 30, 60, and 90) and repeat the experimental protocol. After a two-week washout period, participants will receive a 90-day supply of Atorvastatin and perform baseline and follow-up assessments as above.

Group IV: L-Citrulline, Then PlaceboExperimental Treatment2 Interventions

Participants will receive a 90-day supply of L-Citrulline and perform baseline assessments of resting arterial blood pressure, ECT, arterial elasticity/pulse contour analysis, flow-mediated vasodilation and passive limb movement procedures. Participants will return to the laboratory for up to 5 additional study visits (days 10, 20, 30, 60, and 90) and repeat the experimental protocol. After a two-week washout period, participants will receive a 90-day supply of Placebo and perform baseline and follow-up assessments as above.

Group V: BH4, Then PlaceboExperimental Treatment2 Interventions

Participants will receive a 90-day supply of BH4 and perform baseline assessments of resting arterial blood pressure, ECT, arterial elasticity/pulse contour analysis, flow-mediated vasodilation and passive limb movement procedures. Participants will return to the laboratory for up to 5 additional study visits (days 10, 20, 30, 60, and 90) and repeat the experimental protocol. After a two-week washout period, participants will receive a 90-day supply of Placebo and perform baseline and follow-up assessments as above.

Group VI: Atorvastatin, Then PlaceboExperimental Treatment2 Interventions

Participants will receive a 90-day supply of Atorvastatin and perform baseline assessments of resting arterial blood pressure, ECT, arterial elasticity/pulse contour analysis, flow-mediated vasodilation and passive limb movement procedures. Participants will return to the laboratory for up to 5 additional study visits (days 10, 20, 30, 60, and 90) and repeat the experimental protocol. After a two-week washout period, participants will receive a 90-day supply of Placebo and perform baseline and follow-up assessments as above.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo for Atorvastatin

2000

Completed Phase 3

~630

L-Citrulline

2023

Completed Phase 2

~350