Clinical Trials for Congenital heart defects

Clinical trials are research studies conducted in an effort to improve overall patient health and care. Each trial involves running supervised tests to determine the effectiveness and safety of new drugs, procedures and/or devices with the aim of answering scientific questions about a disease or condition. Risks and side-effects are also evaluated during these trials with results ranging from being unpleasant, with side effects such as headaches, to more serious or even life-threatening risks. A clinical trial may be separated into phases, or steps, with each step designed to answer a separate research question. This maybe reflected in the trial name.

A brief description of each phase:

• Phase I: Usually designed to evaluate safety, determine a safe dosage range, and identify side effects on a small group of patients.
• Phase II: If Phase I is successful, the trial is then repeated with a larger group to further evaluate its effect and safety.
• Phase III: Trials are conducted on an ever larger group and are compared with the best current treatment while gathering more information on effect and safety.
• Phase IV: These studies monitor long-term side effects after the treatment has been marketed.

Clinical Trials data for Congenital heart defects is grouped into the following categories:-

• View by trial name
• View by drugs used in Congenital heart defects clinical trials

Clinical Trials by trial name

The format for each of the following is:

• The name of the trial,
• followed by whether the trial is recruiting patients,
  - The trial may not have started and not yet recruiting, or the trial may have started and do not need any more recruitements, or the trial may be completed.
  - Note**: Please follow the link to determine the current trial status.
• followed by a list of drug/s, if any, used in the trial

ClinicalTrials.gov has listed the following trials for Congenital heart defects:

• Nesiritide Use Following Cardiac Surgery in Infants - This study is currently recruiting patients (Current: 23 Nov 2006) - nesiritide
• Study of Triostat in Infants During Heart Surgery - This study is currently recruiting patients (Current: 23 Nov 2006) - Liothyronine sodium/triiodothyronine
• Physical Activity in Fontan Patients - This study is currently recruiting patients (Current: 23 Nov 2006)
• Genetic and Nutritional Causes of Heart Birth Defects - This study is no longer recruiting patients (Current: 23 Nov 2006)
• Right Ventricular Failure in Congenital Heart Defects - This study is currently recruiting patients (Current: 23 Nov 2006)
• Trial of Cardiac Magnetic Resonance Imaging (MRI) Versus Cardiac Catheterization Prior to Glenn Operation - This study is currently recruiting patients (Current: 23 Nov 2006)
• Infection in DiGeorge Following CHD Surgery - This study is no longer recruiting patients (Current: 23 Nov 2006)
• Heart Failure in Adult Patients With a History of Congenital Heart Disease - This study is no longer recruiting patients (Current: 23 Nov 2006)
• Body Water Content in Cyanotic Congenital Heart Disease - This study has been completed (Current: 23 Nov 2006)
• Study of the Relationship Between Calcium Levels and Intact Parathyroid Hormone (iPTH) in Adults With Repaired or Palliated Conotruncal Cardiac Defects - This study has been completed (Current: 23 Nov 2006) - calcium gluconate,sodium citrate
• Liothyronine in Children With Single Ventricle Congenital Cardiac Malformations Undergoing the Fontan Procedure - This study has been completed (Current: 23 Nov 2006) - liothyronine I 131
• Comparison of Hematocrit Levels in Infant Heart Surgery - This study is no longer recruiting patients (Current: 23 Nov 2006)
• Pediatric Heart Network - This study is currently recruiting patients (Current: 23 Nov 2006)
• Trial of Angiotensin Converting Enzyme Inhibition in Infants With Single Ventricle - This study is currently recruiting patients (Current: 23 Nov 2006) - Enalapril
• Trial of Angiotensin Converting Enzyme Inhibition in Children With Mitral Regurgitation After Repair of Atrioventricular Septal Defect - This study is no longer recruiting patients (Current: 23 Nov 2006) - Enalapril (ACE inhibitor)
• Comparison of Two Types of Shunts in Infants With Single Ventricle Defect Undergoing Staged Reconstruction - This study is currently recruiting patients (Current: 23 Nov 2006)
• Hypertonic Saline Dextran in Pediatric Cardiac Surgery - This study is no longer recruiting patients (Current: 23 Nov 2006) - 7.5% NaCl in 6% dextran 70 solution
• Citrulline for Children Undergoing Cardiopulmonary Bypass Surgery - This study is currently recruiting patients (Current: 23 Nov 2006) - Citrulline
• A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of MEDI-524 - This study is no longer recruiting patients (Current: 23 Nov 2006) - MEDI-524
• Intravenous L-Citrulline to Treat Children Undergoing Heart Bypass Surgery - This study is currently recruiting patients (Current: 23 Nov 2006) - L-citrulline
• Ontario MDCT Coronary Angiography Study (OMCAS) - This study is not yet open for patient recruitment (Current: 23 Nov 2006)
• Efficacy And Safety Of Clopidogrel In Neonates /Infants With Systemic To Pulmonary Artery Shunt Palliation (CLARINET) - This study is currently recruiting patients (Current: 23 Nov 2006) - Clopidogrel
• Evaluation and Treatment of Heart Disease in Patients Not Participating in Research - This study has been completed (Current: 23 Nov 2006)
• Autologous Fresh Whole Blood and Coagulation Following Cardiopulmonary Bypass in Infants - This study has been completed (Current: 23 Nov 2006)
• Signs and Symptoms Associated With Molecular Defects in Genetically Inherited Heart Disease - This study has been completed (Current: 23 Nov 2006)
• Platelet Aggregation Inhibition in Children on Clopidogrel (PICOLO) - This study is no longer recruiting patients (Current: 23 Nov 2006) - Clopidogrel
• Using Tissue Doppler/Synchronization to Determine Heart Function in Children With Congenital Heart Disease - This study is not yet open for patient recruitment (Current: 23 Nov 2006)
• Death Following Congenital Heart Surgery - This study is no longer recruiting patients (Current: 23 Nov 2006)
• Cylexin for Reduction of Reperfusion Injury in Infant Heart Surgery - This study has been completed (Current: 23 Nov 2006) - CY-1503
• Assessing the Hemodynamic Benefits of Cardiac Resynchronization Therapy in Children Following Open-Heart Surgery - This study is currently recruiting patients (Current: 23 Nov 2006)
• Bosentan in Treatment of Pulmonary Arterial Hypertension - This study is currently recruiting patients (Current: 23 Nov 2006) - Bosentan administration
• Follow Up of Post-Repair Tetralogy of Fallot - This study is currently recruiting patients (Current: 23 Nov 2006)
• Infant Heart Surgery: Central Nervous System Sequelae of Circulatory Arrest - This study has been completed (Current: 23 Nov 2006)
• Management of Patent Ductus in Premature Infants - This study has been completed (Current: 23 Nov 2006) - indomethacin
• Positional Cloning of the Gene(s) Responsible for Alagille Syndrome - This study has been completed (Current: 23 Nov 2006)
• Study of Heritable Connective Tissue Disorders - This study has been completed (Current: 23 Nov 2006)
• Immunologic Evaluation in Patients With DiGeorge Syndrome or Velocardiofacial Syndrome - This study is currently recruiting patients (Current: 23 Nov 2006)
• Etiologic Risk Factors of Cardiovascular Malformations - This study has been completed (Current: 23 Nov 2006)
• Reproduction and Survival After Cardiac Defect Repair - This study has been completed (Current: 23 Nov 2006)
• Family Study of Congenital Cardiovascular Malformations - This study has been completed (Current: 23 Nov 2006)
• Molecular Genetic Epidemiology of Endocardial Cushion Defects - SCOR in Pediatric Cardiovascular Disease - This study has been completed (Current: 23 Nov 2006)
• Epidemiology of Persistent Pulmonary Hypertension of the Newborn - SCOR in Lung Biology and Diseases in Infants and Children - This study has been completed (Current: 23 Nov 2006)
• Molecular Genetic Epidemiology of Three Cardiac Defects -SCOR in Pediatric Cardiovascular Disease - This study has been completed (Current: 23 Nov 2006)
• Genetic Study of Patients With Primary Ciliary Dyskinesia - This study has been completed (Current: 23 Nov 2006)
• Study of Energy Expenditure in Infants With Ventricular Septal Defects - This study is currently recruiting patients (Current: 23 Nov 2006)
• Study of Magnesium Sulfate in Children With Reduced Bone Density Secondary to Chronic Cholestatic Liver Disease - This study has been completed (Current: 23 Nov 2006) - magnesium gluconate,magnesium sulfate
• Dexamethasone Treatment for Congenital Heart Block (CHB) in Newborns With Lupus - This study is currently recruiting patients (Current: 23 Nov 2006) - Dexamethasone or other corticosteroid
• Trial of Indomethacin Prophylaxis in Preterm Infants (TIPP) - This study has been completed (Current: 23 Nov 2006) - indomethacin
• Natural History Study of Smith-Magenis Syndrome - This study is currently recruiting patients (Current: 23 Nov 2006)
• Multidisciplinary Study of Right Ventricular Dysplasia - This study is currently recruiting patients (Current: 23 Nov 2006)
• The Research Registry for Neonatal Lupus - This study is currently recruiting patients (Current: 23 Nov 2006)
• Velocardiofacial (VCFS; 22q11.2; DiGeorge) Syndrome Study - This study is currently recruiting patients (Current: 23 Nov 2006)
• Comparison of Two Pulmonary Valve Replacement Methods to Treat Tetralogy of Fallot - This study is currently recruiting patients (Current: 23 Nov 2006)
• Relationship Between Functional Health Status and Ventricular Performance After Fontan (A Trial Conducted by the Pediatric Heart Network) - This study has been completed (Current: 23 Nov 2006)
• Biomodel in Tetralogy of Fallot - This study is currently recruiting patients (Current: 23 Nov 2006)
• Sleep Disordered Breathing in Children With Single Ventricle Physiology - This study is currently recruiting patients (Current: 23 Nov 2006)
• Genetics and Psychopathology in the 22q11 Deletion Syndrome - This study is currently recruiting patients (Current: 23 Nov 2006)
• Nitric Oxide, Endothelin-1, and the Patency of Ductus Arteriosus in Preterm Infants - This study has been completed (Current: 23 Nov 2006)
• 4-D Visualization in Magnetic Resonance Imaging (MRI) in the Congenital Heart Disease Population - This study is currently recruiting patients (Current: 23 Nov 2006)
• NIRS in Neonatal Cardiac Surgery - This study is no longer recruiting patients (Current: 23 Nov 2006)
• PC-Trial: Patent Foramen Ovale and Cryptogenic Embolism - This study is currently recruiting patients (Current: 23 Nov 2006)
• Aortic Regurgitation After Surgical Repair of Outlet-Type Ventricular Septal Defect - This study is currently recruiting patients (Current: 23 Nov 2006)
• International Multi Centre Randomized Clinical Trial Of Anticoagulation In Children Following Fontan Procedures - This study is no longer recruiting patients (Current: 23 Nov 2006) - Warfarin vs ASA
• Comparison of 2 Different Indomethacin Dosing Protocols to Treat Infants Delivered at <28 Weeks Gestation With a Persistent Patent Ductus Arteriosus - This study is currently recruiting patients (Current: 23 Nov 2006) - indomethacin (two different dosing regimens)
• Paradigm I Clinical Trial: Study of the PFX Closure System in Subjects With Cryptogenic Stroke, Transient Ischemia Attack or Paradoxical Embolism - This study is currently recruiting patients (Current: 23 Nov 2006)
• The Paradigm II Trial: PFX Closure System in Subjects With Cryptogenic Stroke, Transient Ischemic Attack, Migraine or Decompression Illness - This study is not yet open for patient recruitment (Current: 23 Nov 2006)
• Evaluation of the STARFlex Septal Closure System in Patients With a Stroke or TIA Due to the Possible Passage of Clot of Unknown Origin Through a Patent Foramen Ovale (PFO) - This study is currently recruiting patients (Current: 23 Nov 2006)
• Safety and Effectiveness Study of the Solysafe Septal Occluder in Patients With Atrial Septum Defect and Patent Foramen Ovale - This study is currently recruiting patients (Current: 23 Nov 2006)
• Critical Congenital Heart Defect (CHD) Outcomes in Children - This study is currently recruiting patients (Current: 23 Nov 2006)
• Ibuprofen and Renal Function in Premature Infants - This study is currently recruiting patients (Current: 23 Nov 2006) - Ibuprofen
• Molecular Genetic Screening and Identification of Congenital Arrhythmogenic Diseases - This study is currently recruiting patients (Current: 23 Nov 2006)
• Optimal Timing for Repair of Left to Right Shunt Lesions - This study is no longer recruiting patients (Current: 23 Nov 2006)
• Relationship of Brain Natriuretic Peptide (BNP) Levels to Cardiac Diagnosis, Operation Performed, Post-Operative Course and Outcome - This study is no longer recruiting patients (Current: 23 Nov 2006)
• New Management Strategy of PDA for VLBW Preterm Infants - This study is currently recruiting patients (Current: 23 Nov 2006) - Indomethacin and Ibuprofen
• Calcium Current in Human Heart Cells - This study is currently recruiting patients (Current: 23 Nov 2006)
• Multisite Feeding Study: Home Surveillance and Feeding Strategies in Infants With Complex Single Ventricle - This study is currently recruiting patients (Current: 23 Nov 2006)
• ESCAPE Migraine Trial - This study is currently recruiting patients (Current: 23 Nov 2006)
• Manifestations of Heritable Disorders of Connective Tissue - This study is currently recruiting patients (Current: 23 Nov 2006)
• Outcomes Following Pulmonary Valve Replacement in Adults - This study is currently recruiting patients (Current: 23 Nov 2006)
• Evaluate Safety/Effectiveness of PFO Closure With the BioSTAR(R) Septal Repair Implant to Resolve Refractory Migraine w/ Aura - This study is currently recruiting patients (Current: 23 Nov 2006)
• Pro-Calcitonin Levels Following Pediatric Cardiac Surgery - This study is currently recruiting patients (Current: 23 Nov 2006)
• Combination Treatment With Bosentan and Sildenafil to Patients With Eisenmengers Syndrome - This study is currently recruiting patients (Current: 23 Nov 2006) - Bosentan and Sildenafil
• Single Ventricle Outcome - This study is currently recruiting patients (Current: 23 Nov 2006)
• Pilot Study of B-Type Natrieutic Peptide (BNP) Levels in Patients With Congenital Heart Disease(BNP) - This study is currently recruiting patients (Current: 23 Nov 2006)
• Rare Genetic Disorders of the Breathing Airways - This study is currently recruiting patients (Current: 23 Nov 2006)
• Pediatric Lead Extractability and Survival Evaluation (PLEASE) - This study is not yet open for patient recruitment (Current: 23 Nov 2006)
• Study of Non-Implant Method to Close Patent Foramen Ovale (PFO) - This study is currently recruiting patients (Current: 23 Nov 2006)
• Genetic Analysis of Left-Right Axis Formations - This study is currently recruiting patients (Current: 23 Nov 2006)
• Transfusion Strategies in Pediatric Cardiothoracic Surgery - This study is currently recruiting patients (Current: 23 Nov 2006)
• Safety and Effectiveness Study of the Solysafe Septal Occluder - This study is not yet open for patient recruitment (Current: 23 Nov 2006)
• Hepatitis C in Adults Who Underwent Congenital Heart Surgery Before Screening - This study is no longer recruiting patients (Current: 23 Nov 2006)
• N-Acetylcysteine in Neonatal Congenital Heart Surgery (INACT Study) - This study is currently recruiting patients (Current: 23 Nov 2006) - N-acetylcysteine
• Safety and Effectiveness of the Nit-Occlud L VSD Spiral Coil System - This study is currently recruiting patients (Current: 23 Nov 2006)
• Neurodevelopmental Outcomes in Hypoplastic Left Heart Syndrome - This study is currently recruiting patients (Current: 23 Nov 2006)
• Safety and Efficacy Study of Sitaxentan Sodium (Thelin) in Patients With Pulmonary Arterial Hypertension - This study has been completed (Current: 23 Nov 2006) - sitaxsentan sodium
• Analgesic Strategies in Newborns Receiving Prostaglandin Therapy - This study is currently recruiting patients (Current: 23 Nov 2006) - acetaminophen and nalbuphine,acetaminophen and morphine,acetaminophen and reduced dosage of protaglandin
• Percutaneous Interventions in Adults With CHD - This study is no longer recruiting patients (Current: 23 Nov 2006)

Drugs used in Clinical Trials for Congenital heart defects

The format for each of the following is:

• The drug,
• followed by the name of the trial,
• followed by whether the trial is recruiting patients,
  - The trial may not have started and not yet recruiting, or the trial may have started and do not need any more recruitements, or the trial may be completed.
  - Note**: Please follow the link to determine the current trial status.

ClinicalTrials.gov has listed the following drugs in trials for Congenital heart defects:

• 7.5% NaCl in 6% dextran 70 solution - Hypertonic Saline Dextran in Pediatric Cardiac Surgery - This study is no longer recruiting patients (Current: 23 Nov 2006)
• Acetaminophen And Morphine - Analgesic Strategies in Newborns Receiving Prostaglandin Therapy - This study is currently recruiting patients (Current: 23 Nov 2006)
• Acetaminophen And Nalbuphine - Analgesic Strategies in Newborns Receiving Prostaglandin Therapy - This study is currently recruiting patients (Current: 23 Nov 2006)
• Acetaminophen And Reduced Dosage Of Protaglandin - Analgesic Strategies in Newborns Receiving Prostaglandin Therapy - This study is currently recruiting patients (Current: 23 Nov 2006)
• Bosentan administration - Bosentan in Treatment of Pulmonary Arterial Hypertension - This study is currently recruiting patients (Current: 23 Nov 2006)
• Bosentan and Sildenafil - Combination Treatment With Bosentan and Sildenafil to Patients With Eisenmengers Syndrome - This study is currently recruiting patients (Current: 23 Nov 2006)
• CY-1503 - Cylexin for Reduction of Reperfusion Injury in Infant Heart Surgery - This study has been completed (Current: 23 Nov 2006)
• Calcium Gluconate - Study of the Relationship Between Calcium Levels and Intact Parathyroid Hormone (iPTH) in Adults With Repaired or Palliated Conotruncal Cardiac Defects - This study has been completed (Current: 23 Nov 2006)
• Citrulline - Citrulline for Children Undergoing Cardiopulmonary Bypass Surgery - This study is currently recruiting patients (Current: 23 Nov 2006)
• Clopidogrel - Efficacy And Safety Of Clopidogrel In Neonates /Infants With Systemic To Pulmonary Artery Shunt Palliation (CLARINET) - This study is currently recruiting patients (Current: 23 Nov 2006)
• Clopidogrel - Platelet Aggregation Inhibition in Children on Clopidogrel (PICOLO) - This study is no longer recruiting patients (Current: 23 Nov 2006)
• Dexamethasone or other corticosteroid - Dexamethasone Treatment for Congenital Heart Block (CHB) in Newborns With Lupus - This study is currently recruiting patients (Current: 23 Nov 2006)
• Enalapril (ACE inhibitor) - Trial of Angiotensin Converting Enzyme Inhibition in Children With Mitral Regurgitation After Repair of Atrioventricular Septal Defect - This study is no longer recruiting patients (Current: 23 Nov 2006)
• Enalapril - Trial of Angiotensin Converting Enzyme Inhibition in Infants With Single Ventricle - This study is currently recruiting patients (Current: 23 Nov 2006)
• Ibuprofen - Ibuprofen and Renal Function in Premature Infants - This study is currently recruiting patients (Current: 23 Nov 2006)
• Indomethacin (Two Different Dosing Regimens) - Comparison of 2 Different Indomethacin Dosing Protocols to Treat Infants Delivered at <28 Weeks Gestation With a Persistent Patent Ductus Arteriosus - This study is currently recruiting patients (Current: 23 Nov 2006)
• Indomethacin and Ibuprofen - New Management Strategy of PDA for VLBW Preterm Infants - This study is currently recruiting patients (Current: 23 Nov 2006)
• Indomethacin - Management of Patent Ductus in Premature Infants - This study has been completed (Current: 23 Nov 2006)
• Indomethacin - Trial of Indomethacin Prophylaxis in Preterm Infants (TIPP) - This study has been completed (Current: 23 Nov 2006)
• L-citrulline - Intravenous L-Citrulline to Treat Children Undergoing Heart Bypass Surgery - This study is currently recruiting patients (Current: 23 Nov 2006)
• Liothyronine I 131 - Liothyronine in Children With Single Ventricle Congenital Cardiac Malformations Undergoing the Fontan Procedure - This study has been completed (Current: 23 Nov 2006)
• Liothyronine sodium/triiodothyronine - Study of Triostat in Infants During Heart Surgery - This study is currently recruiting patients (Current: 23 Nov 2006)
• MEDI-524 - A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of MEDI-524 - This study is no longer recruiting patients (Current: 23 Nov 2006)
• Magnesium Gluconate - Study of Magnesium Sulfate in Children With Reduced Bone Density Secondary to Chronic Cholestatic Liver Disease - This study has been completed (Current: 23 Nov 2006)
• Magnesium Sulfate - Study of Magnesium Sulfate in Children With Reduced Bone Density Secondary to Chronic Cholestatic Liver Disease - This study has been completed (Current: 23 Nov 2006)
• N-acetylcysteine - N-Acetylcysteine in Neonatal Congenital Heart Surgery (INACT Study) - This study is currently recruiting patients (Current: 23 Nov 2006)
• Nesiritide - Nesiritide Use Following Cardiac Surgery in Infants - This study is currently recruiting patients (Current: 23 Nov 2006)
• Sitaxsentan Sodium - Safety and Efficacy Study of Sitaxentan Sodium (Thelin) in Patients With Pulmonary Arterial Hypertension - This study has been completed (Current: 23 Nov 2006)
• Sodium Citrate - Study of the Relationship Between Calcium Levels and Intact Parathyroid Hormone (iPTH) in Adults With Repaired or Palliated Conotruncal Cardiac Defects - This study has been completed (Current: 23 Nov 2006)
• Warfarin vs ASA - International Multi Centre Randomized Clinical Trial Of Anticoagulation In Children Following Fontan Procedures - This study is no longer recruiting patients (Current: 23 Nov 2006)

The trial data on this page has been sourced from

• The U.S. National Library of Medicine (NLM) together with ClinicalTrials.gov

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