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Spironolactone for Single Ventricle Heart Condition
Study Summary
This trial is investigating the effect of Fontan hemodynamics on the interrelationship between liver and cardiac fibrosis/dysfunction and lymphatic congestion. A pilot trial of the antifibrotic agent, spironolactone, will be conducted to prevent these consequences and to determine if MRI can discern these differences.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 4 trial • 79 Patients • NCT02169089Trial Design
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Who is running the clinical trial?
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- I am between 1 and 6 years old, scheduled for a Fontan operation at CHOP, and my parents have agreed.I am between 1 and 6 years old, with a specific heart condition, and planning to have a Fontan operation at CHOP.I am between 1 and 6 years old, scheduled for a Fontan operation at CHOP, and my parents have agreed.My doctor thinks this trial is not safe for me or I have a pacemaker, or I am on specific heart medications.I am not eligible for this trial due to my current condition or treatments.I have a condition or use a device that makes this trial unsafe for me, or I'm taking certain medications.I am between 1 and 6 years old, need anesthesia for a clinical MRI, and my heart and liver are normal.
- Group 1: Observational
- Group 2: Observational - 1A
- Group 3: Control
- Group 4: Observational - 1B
- Group 5: Spironolactone
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Why is Spironolactone prescribed so often?
"Spironolactone can be an effective tool in the treatment of primary hyperaldosteronism, cirrhosis of the liver, and therapeutic procedure."
Is there room for new participants in this experiment?
"The trial, which is currently recruiting patients, was originally posted on February 11th 2021. The most recent update to the listing was made on March 17th of this year."
Are there other Spironolactone clinical trials that have taken place?
"As of right now, there are twenty-nine different ongoing clinical trials studying Spironolactone. Out of those, eight have reached Phase 3. Although a majority of the studies taking place are based in Miami, Florida; there are two hundred and ninety-three research sites total for this medication."
How many people are the most that can enroll in this research project?
"Yes, the trial is still recruiting patients according to the latest information on clinicaltrials.gov. The study was posted on February 11th 2021 and was updated as recently as March 17th 2022. They are looking for a total of 120 individuals across 1 site."
Is this research project looking for participants who are over 45 years old?
"The population that this study is looking to enroll are children who have not yet reached 6 years old, but are above 1 year of age."
How can I become a participant in this clinical trial?
"The study is looking for 120 participants who are between 1 and 6 years old, have a common ventricle, and meet the following additional requirements: Subjects must be single ventricle patients., Must be of either gender and between 1-6 years old, Have parents that sign informed consent, Be scheduled to undergo a Fontan operation at CHOP, Have normal ventricular function and livers."
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