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Mineralocorticoid Receptor Antagonist
Spironolactone for Single Ventricle Heart Condition
Phase 1 & 2
Recruiting
Led By Mark Fogel, MD
Research Sponsored by Children's Hospital of Philadelphia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Cohort 1 (Observational Group - no study medication): Subjects between 1 and ≤ 6 years of age of either gender. Either single left or single right ventricle. Subjects who are scheduled to undergo a Fontan operation at CHOP. Parents signing informed consent.
Cohort 2 (study drug Group - spironolactone): Subjects between 1 and ≤ 6 years of age of either gender. Either single left or single right ventricle. Subjects who are scheduled to undergo a Fontan operation at CHOP. Parents signing informed consent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
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.
Who is the study for?
This trial is for children aged 1 to less than 6 with a single ventricle heart defect, scheduled for Fontan surgery at CHOP. It includes those who agree to MRI scans under sedation and whose parents consent. Excluded are kids already on spironolactone or similar drugs, with severe kidney issues, hyperkalemia, Addison disease, or conditions making the trial harmful.Check my eligibility
What is being tested?
The study tests if spironolactone can prevent heart and liver fibrosis in kids with single ventricle hearts facing Fontan surgery. It uses MRIs and blood markers to track changes non-invasively. Participants will be observed before and after starting the medication.See study design
What are the potential side effects?
Spironolactone may cause electrolyte imbalances like high potassium levels (hyperkalemia), hormonal changes leading to breast enlargement in males (gynecomastia), stomach issues, dizziness, or skin rashes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 1 and 6 years old, scheduled for a Fontan operation at CHOP, and my parents have agreed.
Select...
I am between 1 and 6 years old, scheduled for a Fontan operation at CHOP, and my parents have agreed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Heart
Heart tissue characterization prior to and after Fontan
Liver
+1 moreSecondary outcome measures
Lymphatic dysfunction T1rho prior to and after Fontan
Lymphatic dysfunction by MRE prior to and after Fontan
Serum biomarkers of fibrosis
Side effects data
From 2022 Phase 4 trial • 79 Patients • NCT021690898%
Hypotension
5%
Hyperkalemia
5%
Diabetes related
5%
Infection
3%
Chest pain/discomfort
3%
Breast tenderness/Gynecomastia
3%
Surgical
100%
80%
60%
40%
20%
0%
Study treatment Arm
Spironolactone
Placebo
Trial Design
5Treatment groups
Experimental Treatment
Active Control
Group I: SpironolactoneExperimental Treatment1 Intervention
Children will undergo characterization and measurement of liver and cardiac fibrosis with MRI and cardiac magnetic resonance (CMR) as well as serum biomarkers immediately prior to the Fontan operation.
All SV children will undergo characterization and measurement of liver and cardiac fibrosis with MRI and cardiac magnetic resonance (CMR) as well as serum biomarkers ~1 year after the Fontan operation.
Spironolactone is a mild diuretic. Drug dosage will be those used clinically and per the CHOP formulary: 3 mg/kg/day in divided doses every 6-24 hours; the drug will be weight adjusted every ~0.5 kg with a maximum dosage of 200 mg/24 hours. Maximum single dose is 100 mg.
Spironolactone administration will begin after the Fontan procedure in the hospital prior to discharge or at the first outpatient visit ~ 2 weeks after discharge.
Group II: ControlActive Control1 Intervention
The purpose of this study is to non-invasively characterize the fibrotic consequences of SV physiology, its possible solution and effect on lymphatics. This project investigates the response to acute imposition of Fontan hemodynamics by examining the interrelationship between liver and cardiac fibrosis/dysfunction and lymphatic congestion (figure 1) along with a pilot trial of the antifibrotic agent, spironolactone, to prevent these consequences and to determine if MRI can discern these differences. The combination of serum biomarkers and MRI form a powerful non-invasive tool in putting together this complicated web of dysfunction.
Control subjects who are non-SV patients but who have normal heart function who are undergoing CMR for evaluation (eg patients undergoing CMR for vascular ring evaluation, family history of congenital heart disease but found to be normal, etc) will have study related MRI and CMR sequences performed.
Group III: Observational - 1AActive Control1 Intervention
Subjects who were enrolled in this study in Spironolactone arm and patient's family would like to continue participation.
All SV children, whether they received spironolactone or not, will undergo characterization and measurement of liver and cardiac fibrosis with MRI and cardiac magnetic resonance (CMR) as well as serum biomarkers ~1 year after the Fontan operation. Demographics and medical history will be collected again along with adverse events. Children will also undergo CMR for evaluation of hemodynamics, ventricular function (including strain), computational modeling and lymphatic abnormalities. A few of these patients will be undergoing CMR for clinical reasons and study CMR related and study MRI related imaging and blood draws will be performed in coordination with their clinical care (ie these sequences will be added on to their clinical sequences).
Group IV: ObservationalActive Control1 Intervention
Children will undergo characterization and measurement of liver and cardiac fibrosis with MRI and cardiac magnetic resonance (CMR) as well as serum biomarkers immediately prior to the Fontan operation.
All SV children, whether they received spironolactone or not, will undergo characterization and measurement of liver and cardiac fibrosis with MRI and cardiac magnetic resonance (CMR) as well as serum biomarkers ~1 year after the Fontan operation. Demographics and medical history will be collected again along with adverse events. Children will also undergo CMR for evaluation of hemodynamics, ventricular function (including strain), computational modeling and lymphatic abnormalities. A few of these patients will be undergoing CMR for clinical reasons and study CMR related and study MRI related imaging and blood draws will be performed in coordination with their clinical care (ie these sequences will be added on to their clinical sequences).
Group V: Observational - 1BActive Control1 Intervention
Subjects who were enrolled in other studies with intervention.
All SV children, whether they received spironolactone or not, will undergo characterization and measurement of liver and cardiac fibrosis with MRI and cardiac magnetic resonance (CMR) as well as serum biomarkers ~1 year after the Fontan operation. Demographics and medical history will be collected again along with adverse events. Children will also undergo CMR for evaluation of hemodynamics, ventricular function (including strain), computational modeling and lymphatic abnormalities. A few of these patients will be undergoing CMR for clinical reasons and study CMR related and study MRI related imaging and blood draws will be performed in coordination with their clinical care (ie these sequences will be added on to their clinical sequences).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spironolactone
2005
Completed Phase 4
~7340
Find a Location
Who is running the clinical trial?
Children's Hospital of PhiladelphiaLead Sponsor
708 Previous Clinical Trials
8,581,183 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,834 Previous Clinical Trials
47,310,515 Total Patients Enrolled
Mark Fogel, MDPrincipal InvestigatorChildren's Hospital of Philadelphia
2 Previous Clinical Trials
261 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Observational - 1A
- Group 3: Observational
- Group 4: Observational - 1B
- Group 5: Spironolactone
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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