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Udenafil for Single Ventricle Heart Disease (FUEL-2 Trial)
Phase 3
Recruiting
Research Sponsored by Mezzion Pharma Co. Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Males and females with Fontan physiology who are 12 to less than 19 years of age at enrollment
Current antiplatelet or anticoagulant therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 26 weeks
Awards & highlights
FUEL-2 Trial Summary
This trial will test a drug to help adolescents who had a specific heart surgery.
Who is the study for?
Adolescents aged 12-18 with Fontan physiology, fluent in the study country's primary language, on antiplatelet or anticoagulant therapy can join. Excluded are those under 132 cm tall, pregnant females or not using contraception, recent heart failure hospitalization, severe ventricular dysfunction, and certain medication users.Check my eligibility
What is being tested?
The trial is testing Udenafil against a placebo to see if it's safe and effective for teens who've had the Fontan procedure. Participants will be randomly assigned to either receive Udenafil or a placebo for comparison.See study design
What are the potential side effects?
Udenafil may cause side effects similar to other PDE5 inhibitors like headaches, flushing of the face, nasal congestion, heartburn and potentially serious reactions affecting cardiovascular function.
FUEL-2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 12 and 18 years old with Fontan physiology.
Select...
I am currently on blood thinner medication.
FUEL-2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 26 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 26 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Exercise Capacity
Secondary outcome measures
Change in Enhanced Liver Fibrosis (ELF) Score
Change in VO2 at the ventilatory anaerobic threshold (VAT)
Change in ventilatory efficiency (VE/VCO2) at ventilatory anaerobic threshold
+1 moreFUEL-2 Trial Design
2Treatment groups
Experimental Treatment
Group I: PlaceboExperimental Treatment1 Intervention
Approximately 218 subjects dosed with matching placebo will be enrolled at approximately 30 sites.
Group II: DrugExperimental Treatment1 Intervention
Approximately 218 subjects dosed with udenafil will be enrolled at approximately 30 sites.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Udenafil
2016
Completed Phase 4
~2380
Placebo
1995
Completed Phase 3
~2670
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Single Ventricle Heart Disease (SVHD) aim to improve cardiac output, reduce pulmonary vascular resistance, and enhance exercise capacity. PDE5 inhibitors, such as Udenafil, work by blocking the enzyme phosphodiesterase type 5 (PDE5), which leads to increased levels of cyclic guanosine monophosphate (cGMP).
Elevated cGMP causes relaxation of smooth muscle cells in the pulmonary vasculature, resulting in vasodilation and reduced pulmonary artery pressure. This mechanism is crucial for SVHD patients as it helps to decrease the workload on the single functional ventricle, improve blood flow, and enhance overall cardiovascular efficiency, thereby improving exercise tolerance and quality of life.
Medical treatment of pulmonary hypertension in adults with congenital heart disease: updated and extended results from the International COMPERA-CHD Registry.
Medical treatment of pulmonary hypertension in adults with congenital heart disease: updated and extended results from the International COMPERA-CHD Registry.
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Who is running the clinical trial?
Mezzion Pharma Co. LtdLead Sponsor
4 Previous Clinical Trials
836 Total Patients Enrolled
2 Trials studying Single Ventricle Heart Disease
500 Patients Enrolled for Single Ventricle Heart Disease
John Hariadi, MDStudy DirectorMezzion Pharma Co. Ltd
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