220 Participants Needed

Mechanisms for Symptoms in Congenital Heart Disease

(PACT Trial)

HD
Overseen ByHalley Davison
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Mayo Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand why individuals with congenital heart disease (a condition present from birth) experience symptoms like shortness of breath and heart palpitations. Researchers are examining how these symptoms relate to changes in heart structure. The trial welcomes individuals who have undergone surgery to repair Tetralogy of Fallot or have been diagnosed with certain other heart defects, such as Ebstein's anomaly or coarctation of the aorta. It is ideal for those who have experienced significant heart valve issues, as shown in heart imaging tests. As an unphased study, this trial offers participants the chance to contribute to groundbreaking research that could enhance understanding and treatment of congenital heart disease.

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to uncover the underlying mechanisms causing arrhythmias and reduced aerobic capacity in people with Tetralogy of Fallot and other congenital heart diseases. Unlike current treatments that mainly focus on managing symptoms or correcting structural issues through surgery, this study dives deeper into the physiological processes at play. By understanding these processes, future treatments could be developed to directly address the root causes of these complications, potentially leading to more effective and targeted interventions. This could significantly improve the quality of life for individuals affected by these conditions.

Who Is on the Research Team?

AE

Alexander Egbe, MBBS, MPH

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

Inclusion Criteria

I have moderate or severe pulmonary regurgitation as shown by an echocardiogram.
I have had surgery to correct my Tetralogy of Fallot.
I have been diagnosed with a congenital heart disease such as Ebstein's anomaly or coarctation of the aorta.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observation

Participants are monitored for right heart remodeling and aerobic capacity over the course of the study

24 months

Follow-up

Participants are monitored for safety and effectiveness after the main observation period

4 weeks

What Are the Treatments Tested in This Trial?

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+