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Heart Defects, Congenital clinical trials

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NCT ID: NCT00155285 Recruiting - Heart Diseases Clinical Trials

Evaluating the Infant Complex Congenital Heart Disease by Multidetector Computed Tomography

Start date: January 2000
Phase: N/A
Study type: Interventional

To test the ability of multi-detector spiral CT in evalting the infant complex congenital heart disease.

NCT ID: NCT00132782 Completed - Arrhythmia Clinical Trials

Relationship Between Functional Health Status and Ventricular Performance After Fontan--Pediatric Heart Network

Start date: March 2003
Phase: N/A
Study type: Observational

The purpose of this cross-sectional study was to determine the interrelationships between health status and measures of cardiac performance in children 6 to 18 years of age with congenital heart disease who have undergone a Fontan procedure as surgical treatment for functional single ventricle. The goal was to develop a data set that will permit identification of a clinically relevant endpoint for subsequent trials of medical management of the Fontan patient.

NCT ID: NCT00115934 Completed - Clinical trials for Heart Defects, Congenital

Comparison of Two Types of Shunts in Infants With Single Ventricle Defect Undergoing Staged Reconstruction--Pediatric Heart Network

Start date: May 2005
Phase: Phase 3
Study type: Interventional

This trial will evaluate the efficacy and safety of the modified Blalock-Taussig shunt (MBTS) compared to the right ventricle to pulmonary artery (RV-to-PA) shunt; compare the effect of the MBTS to that of the RV-to-PA shunt on the incidence of death or cardiac transplantation at 12 months post randomization; and compare the effect of the two shunts on intensive care unit (ICU) morbidity, unintended cardiovascular interventional procedures, right ventricular function, tricuspid valve regurgitation, pulmonary artery growth, and neurodevelopmental outcome.

NCT ID: NCT00115375 Completed - Clinical trials for Congenital Heart Defects

Platelet Aggregation Inhibition in Children on Clopidogrel (PICOLO)

Start date: January 2004
Phase: Phase 2
Study type: Interventional

PICOLO is a double blind placebo controlled phase II dose ranging, dose escalating study in patients of Blalock-Taussig age categories (neonates and infants/toddlers), to determine the dose providing inhibition of platelet aggregation similar to adults.

NCT ID: NCT00113698 Terminated - Clinical trials for Heart Failure, Congestive

Angiotensin Converting Enzyme Inhibition in Children With Mitral Regurgitation

AceiMR
Start date: December 2004
Phase: Phase 3
Study type: Interventional

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

NCT ID: NCT00113087 Completed - Clinical trials for Heart Failure, Congestive

Trial of Angiotensin Converting Enzyme Inhibition in Infants With Single Ventricle--Pediatric Heart Network

ISV
Start date: August 2003
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of administering an angiotensin converting enzyme inhibitor (ACE-I) (enalapril) to infants with a functional single ventricle. The study will also compare the effect of ACE-I therapy to placebo on somatic growth and compare the effect of ACE-I therapy to placebo on signs and symptoms of heart failure, neurodevelopmental and functional status, ventricular geometry, function, and atrioventricular (AV) valve regurgitation. In addition, the study will determine the relationship between genetic polymorphisms linked to ventricular hypertrophy (enlarged heart) and the response to ACE-I therapy and compare the incidence of adverse events in subjects treated with ACE-I with those in subjects treated with placebo.

NCT ID: NCT00112424 Completed - Clinical trials for Congenital Heart Defects

Trial of Cardiac Magnetic Resonance Imaging (MRI) Versus Cardiac Catheterization Prior to Glenn Operation

Start date: January 2004
Phase: N/A
Study type: Interventional

This study is a prospective, randomized study of patients with single ventricle heart disease who are to undergo superior cavo-pulmonary anastomosis, or "Glenn" operation. Such patients have historically undergone cardiac catheterization to ensure suitability for the procedure. Cardiac magnetic resonance imaging (cardiac MRI) is a newer technology that provides excellent anatomic and functional imaging of the heart. This study is designed to demonstrate our hypothesis that cardiac magnetic resonance imaging will provide comparable information to catheterization, with less side effects.

NCT ID: NCT00027417 Completed - Clinical trials for Heart Defects, Congenital

Study of Triostat in Infants During Heart Surgery

Start date: April 2001
Phase: Phase 3
Study type: Interventional

This is a study to determine the safety and efficacy of liothyronine sodium/triiodothyronine (Triostat), a synthetic thyroid hormone, when given to infants with congenital heart disease during cardiopulmonary bypass surgery.

NCT ID: NCT00027196 Completed - Clinical trials for Congenital Heart Defect

Signs and Symptoms Associated With Molecular Defects in Genetically Inherited Heart Disease

Start date: April 1998
Phase: N/A
Study type: Observational

Genetically inherited heart diseases (familial cardiopathies) are conditions affecting the heart passed on to family members by abnormalities in genetic information. These conditions are responsible for many heart related deaths and illnesses. Researchers are interested in learning more about the specific genetic abnormalities causing heart diseases. In addition, they would like to find out how these abnormal genes can contribute to the development of other medical problems. In order to do this, researchers plan to study patients and family members of patients diagnosed with genetically inherited heart disease. Those people participating in the study will undergo a variety of tests including blood tests, echocardiograms, and magnetic resonance imaging studies (MRI). These tests will be used to help researchers find the genetic problem causing the familial cardiopathy. Researchers hope that the information gathered from this study can be used to develop better medical care through early diagnosis, management, and treatment plans.

NCT ID: NCT00006186 Completed - Clinical trials for Congenital Heart Defects

Autologous Fresh Whole Blood and Coagulation Following Cardiopulmonary Bypass in Infants

Start date: n/a
Phase: N/A
Study type: Interventional

Dilution of blood caused by cardiopulmonary bypass (the heart-lung machine) during open heart surgery is associated with decreased concentrations in the blood of coagulation factors. This can be extreme in infants because of their small blood volumes and can lead to impairment of the normal blood clotting mechanism and excessive bleeding after the operation. Transfusion of fresh whole blood has been shown to be an effective treatment because fresh blood is rich in coagulation factors. However, it is difficult to obtain truly fresh blood from a blood bank. We hypothesized that fresh blood drawn from the patient and given back after cardiopulmonary bypass would improve the clotting mechanism. In our study, the infants in the treatment group have some of their own fresh blood removed after they are anesthetized for the operation and before they are placed on cardiopulmonary bypass. This blood is then given back to them after completion of cardiopulmonary bypass. Infants in the control group will not have their own blood removed but will undergo cardiopulmonary bypass. We will compare the two groups by drawing blood samples that measure coagulation tests.