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Phosphodiesterase Inhibitor
Tadalafil for Fontan Physiology
Phase 3
Recruiting
Led By Alexander C Egbe, MBBS, MPH
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have previously undergone a Fontan Palliation
Patients must be undergoing a clinically indicated Cardiac Catheterization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights
Study Summary
This trial will test the effects of Tadalafil on Fontan patients' ability to pump blood, their endothelial function, and how well their organs function.
Who is the study for?
Adults over 18 who've had a Fontan Palliation, can exercise on a supine bike, and are able to have an MRI. They must be willing to give written consent and be scheduled for cardiac catheterization. It's not for those under 18, pregnant or breastfeeding women, people on certain heart medications, or unable to exercise.Check my eligibility
What is being tested?
The trial is testing if Tadalafil can improve blood flow (hemodynamics), the health of blood vessels (endothelial function), and organ function in patients with Fontan Physiology compared to a placebo (a substance with no active drug).See study design
What are the potential side effects?
Tadalafil may cause headaches, indigestion, back pain, muscle aches, flushing, stuffy or runny nose. These side effects usually go away after a few hours but can last longer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had a Fontan procedure for my heart condition.
Select...
I am scheduled for a heart catheterization procedure.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Microvascular endothelial function
Pulmonary vascular reserve
Secondary outcome measures
Exercise capacity
Liver stiffness
Patient reported quality of life
+1 moreSide effects data
From 2017 Phase 4 trial • 635 Patients • NCT022248469%
Viral upper respiratory tract infection
3%
Periodontitis
3%
Prostatitis
2%
Alanine aminotransferase increased
2%
Upper respiratory tract infection
2%
Abdominal pain upper
2%
Chronic gastritis
2%
Blood uric acid increased
2%
Insomnia
1%
Eczema
1%
Gout
1%
Back pain
1%
Rhinitis
1%
Sleep disorder
1%
Rhinitis allergic
1%
Pharyngitis
1%
Influenza
1%
Diabetes mellitus
1%
Enteritis
1%
Gastritis
1%
Urinary tract infection
1%
Dizziness
1%
Epistaxis
1%
Renal cyst
1%
Gastric polyps
1%
Gastrooesophageal reflux disease
1%
Nephrolithiasis
1%
Hypertension
1%
Pyrexia
1%
Large intestine polyp
1%
Abdominal distension
1%
Abdominal pain
1%
Dental caries
1%
Diarrhoea
1%
Gamma-glutamyltransferase increased
1%
Headache
1%
Cough
100%
80%
60%
40%
20%
0%
Study treatment Arm
2.5 mg/5 mg Tadalafil
5 mg Tadalafil
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Tadalafil GroupExperimental Treatment1 Intervention
Study participants will receive 10 mg of Tadalafil daily for 1 week, then 20 mg daily for 1 week, and finally 40 mg daily for 50 weeks for a total therapy time of 52 weeks. Tadalafil will be taken orally in capsule form once daily.
Group II: Placebo GroupPlacebo Group1 Intervention
Study participants will receive a placebo capsule that looks identical to the Tadalafil capsule. The placebo will be taken orally once daily for 52 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tadalafil
FDA approved
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,210 Previous Clinical Trials
3,766,893 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,837 Previous Clinical Trials
47,851,547 Total Patients Enrolled
Alexander C Egbe, MBBS, MPHPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am under 18 years old.I am willing and able to sign a consent form.I am not on any IV drugs to strengthen my heart muscle.I have had a Fontan procedure for my heart condition.I am not currently taking alpha-blockers, pulmonary vasodilators, or nitrates.I am scheduled for a heart catheterization procedure.I am 18 years old or older.
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
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.
Research Study Groups:
This trial has the following groups:- Group 1: Tadalafil Group
- Group 2: Placebo Group
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any life-threatening risks to taking Tadalafil?
"Tadalafil has received a score of 3 for safety."
Answered by AI
What is the recruitment goal for this clinical trial?
"Yes, that is correct. The clinicaltrials.gov website shows that this study is open for recruitment. This particular trial was posted on September 16th, 2022 and was last updated on October 10th, 2022. Only 80 patients are needed for this study which is taking place at 1 site."
Answered by AI
What are the researchers hoping to discover through this trial?
"The 52 week trial's primary focus is to study microvascular endothelial function with secondary measures of exercise capacity, liver stiffness, and patient reported quality of life."
Answered by AI
Are we currently looking for new participants for this research project?
"That is correct, the clinicaltrials.gov website shows that this study is open for recruitment. The trial was originally posted on September 16th, 2022 and was most recently edited on October 10th, 2022. The study is enrolling 80 patients at 1 site."
Answered by AI
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