San Diego, CANCT05918211Now EnrollingIRB Ready

Single Ventricle Heart Disease Clinical Trial in San Diego, CA

Access cutting-edge single ventricle heart disease treatment through this phase 3 clinical trial at a research site in San Diego. Study-provided care at no cost to qualified participants.

Sponsored by Mezzion Pharma Co. Ltd

Quick Self-Assessment

See if you qualify for this San Diego location

Preparing your pre-screening questions…

Expert Care in San Diego

Access single ventricle heart disease specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related single ventricle heart disease treatment provided free

Apply for This San Diego Location

Check if you qualify for this single ventricle heart disease clinical trial in San Diego, CA

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to San Diego

    Convenient for CA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit San Diego site if eligible
  4. 4Begin participation

About This Single Ventricle Heart Disease Study in San Diego

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.

Sponsor: Mezzion Pharma Co. Ltd

Who Can Participate

Inclusion Criteria

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.

Exclusion Criteria

Height \< 132 cm.
Weight \< 40 kg.
Hospitalization for acute decompensated heart failure within the last 12 months.
Current intravenous inotropic drugs.
Undergoing evaluation for heart transplantation or listed for transplantation.
Diagnosis of active protein losing enteropathy or plastic bronchitis within the last 3 years, or a history of liver cirrhosis.
Known Fontan baffle obstruction, branch pulmonary artery stenosis, or pulmonary vein stenosis resulting in a mean gradient of \> 4 mmHg between the regions proximal and distal to the obstruction as measured by either catheterization or echocardiography, obtained prior to screening for the trial.
Single lung physiology with greater than 80% flow to one lung.
Failure to achieve maximal exertion (defined as RER \< 1.10) on screening/baseline exercise test.
Peak minute oxygen consumption (VO2) less than 45% or ≥ 80% of predicated for age and gender at enrollment.
Severe ventricular dysfunction assessed qualitatively by clinical echocardiography within 6 months prior to enrollment.
Severe valvar regurgitation, ventricular outflow obstruction, or severe aortic arch obstruction assessed by clinical echocardiography within six months prior to enrollment.
History of significant renal (serum creatinine \> 2.0), hepatic (serum AST and/or ALT \> 3 times upper limit of normal), gastrointestinal or biliary disorders that could impair absorption, metabolism or excretion of orally administered medications.
Inability to complete exercise testing at baseline screening.
Subjects with a pacemaker whose heart rate at peak exercise is controlled by the extrinsic pacemaker as opposed to a native atrial rhythm.
History of PDE-5 inhibitor use within 12 months prior to enrollment. (Treatment is defined as chronic therapy as opposed to a single dose.)
History of any other medication for treatment of pulmonary hypertension within 3 months before study onset.
Known intolerance to oral udenafil.
Frequent use of medications or other substances that inhibit or induce CYP3A4.
Current use of alpha-blockers or nitrates.
Ongoing or planned participation in another research protocol that would either prevent successful completion of planned study testing or invalidate its results.
Noncardiac medical, psychiatric, and/or social disorder that would prevent successful completion of planned study testing or would invalidate its results.
Cardiac care, ongoing or planned, at a non-study center that would impede study completion.
For females: Pregnancy at the time of screening, pregnancy planned before study completion, or refusal to use an acceptable method of contraception for study duration if sexually active.
Unable to abstain or limit intake of grapefruit juice and grapefruit containing drinks during the duration of the trial.
Refusal to provide written informed consent/assent.
In the opinion of the investigator, the subject is likely to be non-compliant with the study protocol.
History of clinically significant thromboembolic event, in the option of the site Principal Investigator, that may put the subject at increased risk of a subsequent event while participating in the study.
Coronavirus disease 2019 (COVID-19) vaccination or symptoms of COVID-19 infection within 7 days of Visit 1.
Not taking antiplatelet or anticoagulant therapy.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in San Diego?

Yes, this clinical trial (NCT05918211) has an active research site in San Diego, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Single Ventricle Heart Disease Treatment Options in San Diego, CA

If you're searching for single ventricle heart disease treatment options in San Diego, CA, this clinical trial (NCT05918211) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our San Diego research site is actively enrolling participants for this phase 3 clinical trial. You'll receive care from experienced single ventricle heart disease specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all single ventricle heart disease clinical trials near you to find additional studies recruiting in your area.

More Heart Disease Trials in San Diego, CA

See all heart disease clinical trials recruiting in San Diego — not just this study.

Browse Heart Disease Trials in San Diego →

Browse More Trials by Condition

Heart Disease TrialsAnkylosing Spondylitis TrialsInterstitial Cystitis TrialsAll Conditions →

Ready to Join in San Diego?

Take the first step toward participating in this groundbreaking clinical trial

Secure · Expert Care · San Diego, CA