Mitral Regurgitation (ACE-I in MR) Study Basics

ACE-I in MR is a Trial of ACE Inhibition Therapy in Children with Mitral Regurgitation (MR) after Repair of an Atrioventricular Septal Defect (AVSD) . The short title for the study is ACE-I in MR. When this study first started, there were two parts. The first part, the observational study , was being done to see if mitral valve leaking decreases after surgery for AVSD repair. The observational study will enroll 180 people and started on 06/01/2004. The second part of this study stopped on November 4, 2005 due to poor enrollment. It was being done to see if giving a medication called Enalapril (an ACE inhibitor) will improve severe mitral valve regurgitation (leaking of the mitral valve) and decrease the heart size in patients who have had an AVSD (a hole in the heart) repaired.

How many people participated in the study?

The observational study enrolled 181 people.

Who was in the study?

Participants were eligible if:

• The AVSD repair was less than 28 days before enrollment.
• 17.5 years or less.
  

What happened in the observational study?

Each eligible participant was asked to sign an informed consent form to allow the study staff to review and record information the medical chart. The amount of mitral valve leaking was be evaluated after an echocardiogram . A second echocardiogram was done at 6 months to compare the amount of MR with the amount seen on the first echocardiogram.

What were the results of the study?

This study ended on January 31, 2006 and results are currently being analyzed.

ACE-I in MR for Parents
                           
Title
Trial of ACE Inhibition Therapy in Children with Mitral Regurgitation (MR) after Repair of an Atrioventricular Septal Defect (AVSD)

Short Title
ACE-I in MR

What was the purpose?
When this study first started, there were two parts. The first part, the observational study was being done to see if mitral valve leaking decreases after surgery for AVSD repair.  The second part of this study stopped on November 4, 2005 due to poor enrollment. It was being done to see if giving a medication called Enalapril (an ACE inhibitor) will improve severe mitral valve regurgitation (leaking of the mitral valve) and decrease the heart size in patients who have had an AVSD (a hole in the heart) repaired.   

How many people participated in the observational study?
The observational study enrolled 181 people.

Who was in the study?
Participants were eligible if:

• The AVSD repair was less than 28 days before enrollment.
• 17.5 years or less.

What happened in the observational study?
Each eligible participant was asked to sign an informed consent form to allow the study staff to review and record information the medical chart. The amount of mitral valve leaking was be evaluated after an echocardiogram. A second echocardiogram was done at 6 months to compare the amount of MR with the amount seen on the first echocardiogram. 

What were the results of the study? 
Surgical repair of all AVSD types results in low morbidity and mortality and short hospital stays. Repair is associated with catch-up growth, particularly in underweight children with a partial or transitional AVSD repaired between 3 and 18 months of age.  Mitral regurgitation remains the most common residual defect.