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NCT05918211RECRUITINGIRB Ready

Fontan Udenafil Exercise Longitudinal Assessment Trial - 2

(FUEL-2)

Sponsored by Mezzion Pharma Co. Ltd

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
๐Ÿ“Š
1 of 436 participants interested
0% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

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

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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.

Who Can Participate

Inclusion Criteria

Males and females with Fontan physiology who are 12 to less than 19 years of age at enrollment. 2. Participant consent or parental/guardian consent and participant assent. 3. Participant fluency in primary language of country in which study is being conducted. 4. Current antiplatelet or anticoagulant therapy.

Exclusion Criteria

Height \< 132 cm. 2. Weight \< 40 kg. 3. Hospitalization for acute decompensated heart failure within the last 12 months. 4. Current intravenous inotropic drugs. 5. Undergoing evaluation for heart transplantation or listed for transplantation. 6. Diagnosis of active protein losing enteropathy or plastic bronchitis within the last 3 years, or a history of liver cirrhosis. 7. 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

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

๐Ÿ‘ฅ

Target Enrollment

436 participants

๐ŸŽ‚

Age Range

12 Years - 18 Years

โšง

Gender

ALL

๐Ÿข

Sponsor

Mezzion Pharma Co. Ltd

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Phoenix

Arizona

Location available
View Phoenix location page
RECRUITING

Little Rock

Arkansas

Location available
View Little Rock location page
RECRUITING

Los Angeles

California

Location available
View Los Angeles location page
RECRUITING

San Diego

California

Location available
View San Diego location page
RECRUITING

San Francisco

California

Location available
View San Francisco location page
RECRUITING

Denver

Colorado

Location available
View Denver location page
RECRUITING

New Haven

Connecticut

Location available
View New Haven location page
RECRUITING

Wilmington

Delaware

Location available
View Wilmington location page
RECRUITING

Washington D.C.

District of Columbia

Location available
View Washington D.C. location page

๐Ÿ“ And 28 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

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

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

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

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Single Ventricle Heart Disease Treatment in Phoenix?

Join others in Arizona exploring innovative treatment options through clinical research

Single Ventricle Heart Disease Treatment Options in Phoenix, Arizona

If you're searching for Single Ventricle Heart Disease treatment in Phoenix, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Phoenix, Little Rock, Los Angeles and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Single Ventricle Heart Disease. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Arizona
Now Enrolling
Up to 436 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Single Ventricle Heart Disease?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Single Ventricle Heart Disease

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Single Ventricle Heart Disease Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT05918211. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.