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Exercise + BH4 for Heart Failure

Phase < 1
Recruiting
Led By David W. Wray, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Women currently taking hormone replacement therapy (HRT)
Patients with atrial fibrillation or HF believed to be secondary to atrial fibrillation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up four years

Summary

This trial is studying how impaired muscle blood flow contributes to exercise intolerance in Veterans with heart failure and a reduced ejection fraction. They hope to develop strategies for restoring exercise tolerance and slowing disease progression in this patient group.

Who is the study for?
This trial is for stable cardiomyopathy patients aged 45-75 who've been on optimal heart failure treatment for at least 6 weeks. They should have severe heart function reduction, minimal smoking history, and be able to exercise without orthopedic limits. Excluded are those with extreme obesity, uncontrolled high blood pressure, severe kidney issues, sedentary lifestyle, certain heart rhythm problems or diseases causing their heart failure.
What is being tested?
The study tests if antioxidants and a compound called Tetrahydrobiopterin (BH4), along with exercise training can improve muscle blood flow and exercise tolerance in people with reduced ejection fraction heart failure (HFrEF). The goal is to slow disease progression and enhance quality of life.
What are the potential side effects?
Potential side effects may include typical risks associated with physical activity such as muscle soreness or strain. Antioxidants generally have low risk but could cause stomach upset or allergic reactions. BH4's side effects might include headache, diarrhea, or flushing.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently on hormone replacement therapy.
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My heart condition is due to atrial fibrillation.
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I cannot perform exercises that require bending my knee due to physical limitations.
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I am a woman who has been through menopause naturally or by surgery.
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I am not morbidly obese, do not have uncontrolled high blood pressure, severe anemia, or severe kidney problems.
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I have not been physically active for the last 6 months.
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I have a serious health condition such as severe lung disease, diabetes on insulin, or advanced cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~four years
This trial's timeline: 3 weeks for screening, Varies for treatment, and four years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Blood Flow

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: Oral BH4Experimental Treatment1 Intervention
8 week oral tetrahydrobiopterin treatment
Group II: Oral AOxExperimental Treatment1 Intervention
8 week oral antioxidant treatment
Group III: Ex trainingExperimental Treatment1 Intervention
8-week knee-extensor exercise training program
Group IV: Oral BH4 (placebo)Placebo Group1 Intervention
Placebo for arm 3
Group V: Oral AOx (placebo)Placebo Group1 Intervention
Placebo for arm 1
Group VI: Ex training (attn con)Placebo Group1 Intervention
Attention control for arm 5
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Antioxidant
2014
N/A
~780
Tetrahydrobiopterin (BH4)
2015
Completed Phase 2
~80

Find a Location

Who is running the clinical trial?

University of UtahOTHER
1,141 Previous Clinical Trials
1,697,659 Total Patients Enrolled
18 Trials studying Heart Failure
5,339 Patients Enrolled for Heart Failure
VA Office of Research and DevelopmentLead Sponsor
1,664 Previous Clinical Trials
3,765,585 Total Patients Enrolled
39 Trials studying Heart Failure
63,175 Patients Enrolled for Heart Failure
David W. Wray, PhDPrincipal InvestigatorVA Salt Lake City Health Care System, Salt Lake City, UT
1 Previous Clinical Trials
30 Total Patients Enrolled
1 Trials studying Heart Failure
30 Patients Enrolled for Heart Failure

Media Library

Exercise training Clinical Trial Eligibility Overview. Trial Name: NCT03136029 — Phase < 1
Heart Failure Research Study Groups: Oral BH4 (placebo), Ex training, Oral AOx, Oral AOx (placebo), Ex training (attn con), Oral BH4
Heart Failure Clinical Trial 2023: Exercise training Highlights & Side Effects. Trial Name: NCT03136029 — Phase < 1
Exercise training 2023 Treatment Timeline for Medical Study. Trial Name: NCT03136029 — Phase < 1
~10 spots leftby May 2025
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