Clinical Trials Logo

Clinical Trial Summary

This study will evaluate the efficacy and safety of angiotensin converting enzyme inhibition (ACE-I) therapy for the treatment of mitral regurgitation (MR).


Clinical Trial Description

BACKGROUND:

MR causes volume overload and hemodynamic burden on the left ventricle. Initial compensatory mechanisms may fail, leading to increased severity. Patients who have had repair of an atrioventricular septal defect (AVSD) are selected for this study as they have a relatively high incidence of moderate MR and their regurgitant orifice is mobile and dynamic, contributing to the likelihood that they might respond to medical therapy.

DESIGN NARRATIVE:

This is a randomized, double-blind, placebo-controlled trial of ACE-I therapy in children less than 18 years of age with at least moderate MR who are at least 6 months postoperative from repair of an AVSD. A non-randomized Observational Phase enrolled 181 children who were less than 6 months postoperative from repair of an AVSD, who were then evaluated at 6 months for trial eligibility. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00113698
Study type Interventional
Source University of Utah
Contact
Status Terminated
Phase Phase 3
Start date December 2004
Completion date January 2006

See also
  Status Clinical Trial Phase
Completed NCT01357850 - A Multi-center, Placebo-controlled Study to Evaluate the Safety of GSK716155 and Its Effects on Myocardial Metabolism, Myocardial Function, and Exercise Capacity in Patients With NYHA Class II/III Congestive Heart Failure Phase 2
Recruiting NCT00532688 - N-Acetylcysteine in Heart Failure With Coexistent Chronic Renal Failure Phase 2/Phase 3
Terminated NCT00383630 - Bone Marrow Cell Transplantation to Improve Heart Function in Individuals With End-Stage Heart Failure Phase 2
Completed NCT00531661 - CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients N/A
Completed NCT00149435 - Cardiovascular Health Study (CHS) Events Follow-up Study
Completed NCT00241761 - Epidemiology of Depression and Heart Failure in Aging N/A
Completed NCT00159614 - Effect of KW-3902IV in Combination With IV Furosemide on Renal Function in Subjects With CHF and Renal Impairment Phase 2
Terminated NCT00125437 - Larger Dose of Spironolactone for the Treatment of Patients With Nonischemic Cardiomyopathy N/A
Terminated NCT00357591 - Randomized Trial for Patients With Chronic Heart Failure With Acute Decompensation N/A
Completed NCT00202579 - Efficacy and Safety of Ivabradine in Severe Congestive Heart Failure Phase 2
Completed NCT00094263 - Long-Term Predictors of Morbidity in Older Age N/A
Completed NCT00048425 - Evaluation of Intravenous Levosimendan Efficacy in the Short Term Treatment of Decompensated Chronic Heart Failure. Phase 3
Completed NCT00530426 - Heart Failure Registry Phase 4
Completed NCT00023556 - Genetic Architecture of Heart Disease in Rural Brazil N/A
Terminated NCT00190359 - Growth Hormone and Heart Failure N/A
Completed NCT00004562 - Occluded Artery Trial (OAT) Phase 3
Completed NCT00005265 - Natural History of Coronary Heart Disease N/A
Completed NCT02772068 - Hemodynamic Response to Exercise in HFpEF Patients After Upregulation of SERCA2a Early Phase 1
Completed NCT02925546 - A Phase I Study to Assess the Pharmacokinetics of GSK2798745 Tablets Phase 1
Completed NCT01074307 - A Prospective, Open-labeled, Multi-centric Trial in Subjects With Systolic Heart Failure to Evaluate Bisoprolol Treatment for the Effects on Surrogate Markers of Heart Failure in Korea Phase 4