Health TrialsbyHealthPanel

Fontan Udenafil Exercise Longitudinal Assessment Trial - 2

ConditionSingle Ventricle Heart Disease
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12-18
SponsorMezzion Pharma Co. Ltd

About this trial

This study will evaluate the clinical efficacy and safety of udenafil, an orally administered, potent and selective inhibitor of PDE5, versus placebo for the treatment of adolescent who have had the Fontan procedure.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Males and females with Fontan physiology who are 12 to less than 19 years of age at enrollment.

Participant consent or parental/guardian consent and participant assent.

Participant fluency in primary language of country in which study is being conducted.

Current antiplatelet or anticoagulant therapy.

Disqualifiers

Height < 132 cm.

Weight < 40 kg.

Hospitalization for acute decompensated heart failure within the last 12 months.

Current intravenous inotropic drugs.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Udenafil

    Drug

    Active drug

  • Placebo

    Drug

    Matching Placebo

Treatment groups

436 Participants
are divided into 2 treatment groups
Group A: DrugExperimental treatment 1 intervention
Group B: PlaceboExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Exercise Capacity

The change in exercise capacity (as measured by maximal VO2 at maximum exercise effort) from baseline to 26 weeks (or study completion)

Time frame
Baseline to 26 Weeks

Secondary outcomes

1

Change in VO2 at the ventilatory anaerobic threshold (VAT)

Change in peak oxygen consumption (VO2) from baseline to Week 26 as measured by maximal central cardiopulmonary exercise test (CPET) reading laboratory.

Time frame
Baseline to 26 weeks
2

Change in Enhanced Liver Fibrosis (ELF) Score

Change from baseline to Week 26 in the Enhanced Liver Fibrosis (ELF) Score calculated by the change in the following biomarkers: hyaluronic acid, amino-terminal propeptide of type III collagen, and tissue inhibitor of metalloproteinase-1. subjects with scores of \<7.7 were assigned to the no or mild fibrosis group; 7.7 to 9.8 to the moderate fibrosis group, and \>9.8 to the severe fibrosis group.

Time frame
Baseline to 26 weeks
3

Work rate (watts) at ventilatory anaerobic threshold (VAT)

Change from baseline to 26 weeks in work rate in watts at the ventilatory anaerobic threshold as measured by the central cardiopulmonary exercise test reading laboratory.

Time frame
Baseline to 26 weeks
4

Change in ventilatory efficiency (VE/VCO2) at ventilatory anaerobic threshold

Change from baseline to Week 26 in ventilatory efficiency calculated by ventilatory efficiency divided by minute carbon dioxide production at the ventilatory anaerobic threshold (VE/VCO2 at VAT).

Time frame
Baseline to 26 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mezzion Pharma Co. Ltd

Lead sponsor

Source ClinicalTrials.gov
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