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BH4 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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Flow-mediated dilation (FMD)

Secondary outcome measures

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

BH4

2016

Completed Phase 2

~30

L-Citrulline

2023

Completed Phase 2

~340

Atorvastatin

1998

Completed Phase 4

~10900

Placebo for Atorvastatin

2000

Completed Phase 3

~630

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

D. Walter WrayLead Sponsor

US Department of Veterans AffairsFED

868 Previous Clinical Trials

487,800 Total Patients Enrolled

31 Trials studying Heart Failure

10,818 Patients Enrolled for Heart Failure

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals being recruited for participation in this research?

"Indeed, the information available on clinicaltrials.gov shows that this trial is actively seeking volunteers. It was initially posted on May 19, 2021 and has been recently updated on March 8, 2024. The investigation aims to recruit a total of 90 participants from one designated site."

Answered by AI

Is the recruitment of participants currently ongoing for this clinical trial?

"Yes, the details available on clinicaltrials.gov specify that this investigation is actively seeking volunteers. The trial was posted for the first time on May 19th, 2021, and its latest revision was made on March 8th, 2024. This study aims to enroll a total of 90 participants at a single designated site."

Answered by AI

What are the potential risks associated with L-Citrulline compared to a placebo for individuals?

"Based on our assessment at Power, the safety of L-Citrulline compared to Placebo is rated as 1 due to this being a Phase 1 trial with restricted evidence supporting both safety and effectiveness."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Novel Approaches for Improving Vascular Function in Veterans With HFpEF

D. Walter Wray 2021. "Novel Approaches for Improving Vascular Function in Veterans With HFpEF". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06312748.

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