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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up four years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ four years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~four years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
1,099 Previous Clinical Trials
1,778,582 Total Patients Enrolled
17 Trials studying Heart Failure
3,139 Patients Enrolled for Heart Failure
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,289 Total Patients Enrolled
38 Trials studying Heart Failure
63,048 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You can only join the study if you have specific heart symptoms, low heart function, hardly smoke, and do not have a pacemaker.My heart failure is not due to untreated major valve problems, except for issues caused by a weak left ventricle.I am on heart failure treatment as per AHA/ACC/HFSA guidelines or have a valid reason for not following them.I am currently on hormone replacement therapy.My heart condition is due to atrial fibrillation.I have had a stable heart condition for over 3 months, despite treatment.I cannot perform exercises that require bending my knee due to physical limitations.I am a woman who has been through menopause naturally or by surgery.I am not morbidly obese, do not have uncontrolled high blood pressure, severe anemia, or severe kidney problems.I have not been physically active for the last 6 months.I have a serious health condition such as severe lung disease, diabetes on insulin, or advanced cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Oral BH4 (placebo)
- Group 2: Ex training
- Group 3: Oral AOx
- Group 4: Oral AOx (placebo)
- Group 5: Ex training (attn con)
- Group 6: Oral BH4
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are being included in this experiment?
"Affirmative, the information posted on clinicaltrials.gov indicates that this study is currently recruiting participants. The trial was initially posted on June 1st 2018 and its most recent update happened on June 17th 2022. 140 individuals are required for the experiment to take place at one medical facility."
Answered by AI
Are there any available patient slots for this trial?
"Affirmative. According to clinicaltrials.gov, this trial has been open since June 1st 2018 and is actively recruiting patients; 140 participants need to be enrolled at a single medical site."
Answered by AI
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