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Heart Defects, Congenital clinical trials

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NCT ID: NCT02564796 Terminated - Anemia Clinical Trials

Erythropoietin to Prevent Unnecessary Transfusions In Patients With Cyanotic CHD - A Prospective Control Trial

Start date: November 2016
Phase: Phase 2
Study type: Interventional

Cyanotic congenital cardiac patients require higher hemoglobin concentrations (red blood cell levels) for optimal oxygen delivery to the body. Prophylactic erythropoietin (EPO) and iron can prevent and/or decrease the amount of blood transfusions needed in this population. We seek to investigate if EPO and iron make a clinically significant difference in the number of transfusions given to these patients and the morbidity associated with it.

NCT ID: NCT02561975 Completed - Clinical trials for Complex Congenital Heart Disease

Adaptation of Alveolar-capillary Diffusion at Effort of Subjects Suffering From Complex Congenital Heart Disease

CAR-DIFF
Start date: December 2014
Phase: N/A
Study type: Interventional

An injury of haematosis in post ischemic chronic heart failure limits the clinic tolerance. There is a correlation between injury of pulmonary diffusing, chronic heart failure intensity and aerobic physic ability evaluated by an heart-rate maximal exercise tolerance test (VO2 max). This injury is a new follow-up parameter of cardiac function for the adult. The nature of damage (vascular or membrane) can be determined by the measure of double pulmonary diffusing capacity to carbon monoxide (CO) associated to nitric oxide (NO). Today, in chronic heart failure consecutive to a congenital heart disease, there is no data on evolution of membrane and capillar factors.It is impossible to predict if membrane damage will be the best factor correlated to the VO2max in patients suffering from complex congenital heart disease. Assessing these parameters could be an comparative evaluation of heart-rate exercise tolerance test with VO2max and an early control of his damage without risks related to heart-rate maximal exercise and independently of age, sex, hemoglobin, type of heart disease.These results would have an early prognostic value that would permit to refine the follow-up and the treatment. The main objective of this trial is to assess the statistic correlation between the membrane injury of alveolar-capillary diffusing at rest and aerobic physic ability restriction in children and adults suffering from complex congenital heart disease.

NCT ID: NCT02555319 Completed - Clinical trials for Congenital Heart Defects

A Feasibility Study to Evaluate the Safety and Short-term Effectiveness of Transcatheter Pulmonary Valve (TPV)

Start date: August 26, 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the safety and short-term effectiveness of implantation of Transcatheter Pulmonary Valve (TPV) for the treatment of congenital heart disease with pulmonary valve disease.

NCT ID: NCT02551107 Terminated - Clinical trials for Congenital Heart Disease

Infant Nasal Nitric Oxide Levels in Congenital Heart Disease

Start date: December 2015
Phase: N/A
Study type: Interventional

This pilot study aims to measure nasal nitric oxide (nNO) in a group of neonates and infants (≤ 12 months) with congenital heart disease (CHD) and compare their nNO levels to age matched controls without CHD. CHD patients will be divided into subgroups, based on their cardiac anatomy, to try and identify a level of risk of ciliary dyskinesia within the subgroup of CHD. Each of these sub groups' nNO levels will be compared between groups and against age matched control infants without CHD.

NCT ID: NCT02549625 Completed - Clinical trials for Congenital Heart Disease

Phase I Safety and Feasibility Study of Intracoronary Delivery of Autologous Bone Marrow Derived Mononuclear Cells

Start date: August 2015
Phase: Phase 1
Study type: Interventional

The objective of this study is to determine the safety and feasibility of autologous mononuclear cells (MNC) collected from bone marrow (BM) and intracoronary delivery for individuals with declining performance of their single right ventricle systemic pumps. This procedure has the potential to foster a new strategy for congenital heart patients. This is an open-label study of autologous MNC derived from bone marrow with a 2-year follow-up to document 1) related serious adverse events and 2) monitor changes in cardiac structure and function.

NCT ID: NCT02542683 Recruiting - Children Clinical Trials

Physical Activity and Cognitive Development in Children

Start date: April 2016
Phase:
Study type: Observational

1. Compare physical activity and cognitive functions between children having cardiac surgery with an age-matched group of children undergoing non-cardiac surgery, as well as otherwise healthy siblings or best buddies (or age and gender-matched children if no siblings or best buddies available) before surgery and after surgery or six months following initial assessment. 2. Determine the effects of a structured physical activity program for 6 months following surgery on cognitive functions and adaptive behavior in children following congenital cardiac surgery. 3. Determine the effects of a structured physical activity program for 12 months following surgery on cognitive functions and adaptive behavior in children following congenital cardiac surgery. 4. We will perform exploratory analysis to determine whether any effects of a 12-months structured physical activity program on cognitive functions and adaptive behavior persist beyond 12 months after cessation of the program.

NCT ID: NCT02537392 Completed - Clinical trials for Congenital Heart Disease

Multi-micronutrient Supplementation During Peri-conception and Congenital Heart Disease

Start date: September 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether daily oral supplements of vitamin B complex along with folic acid or supplements of iron plus folic acid given to women during peri-conception can reduce the risk of congenital heart disease when compared with folic acid alone.

NCT ID: NCT02527811 Enrolling by invitation - Clinical trials for Congenital Heart Diseases

Ulinastatin Injection in in Pediatric Patients Undergoing Open Heart Surgery

Start date: April 2015
Phase: Phase 4
Study type: Interventional

1. Explore the efficacy of Ulinastatin use in improving post-operative pulmonary insufficiency and safety in pediatric patients undergoing scheduled CPB open heart surgery to treat Complex Congenital Heart Disease 2. Explore the efficacy of Ulinastatin use in improving intraoperative hemodynamic instability as well as other post-operative organ recuperation and its impact on hospital stay & cost

NCT ID: NCT02519335 Terminated - Clinical trials for Heart Defects, Congenital

Use of the Cardioprotectant Dexrazoxane During Congenital Heart Surgery: Proposal for Pilot Investigation

Start date: September 2014
Phase: Phase 1
Study type: Interventional

Cardiopulmonary bypass and arrest of the heart during cardiac surgery are necessary to allow the surgeon to perform heart operations. However, these processes can cause injury to the heart which may worsen post-operative outcomes. In fact, the effects of these injuries may continue after surgery, and lead to a long-term decrease in heart function. Neonates and young infants are at particular risk for this occurrence. While much research has been done in adults looking for medicines that might protect the heart during surgery, few studies have been conducted in neonates and young infants. The investigators are testing Dexrazoxane, which has proven to be cardio-protective in pediatric cancer patients, in the hope that it may lessen cardiac injury during and after congenital heart surgery, and thereby improve outcomes in the neonatal and young infant population. In order to accomplish this, the investigators must first determine how Dexrazoxane can be safely administered to young children with congenital heart disease. Therefore, the investigators are performing a pilot study of 12 children to assess: 1. how Dexrazoxane at 3 different doses is metabolized in the body of a child age 0-6 months during and after congenital heart surgery, and 2. the safety of Dexrazoxane use in the neonatal and young infant population undergoing cardiac surgery.

NCT ID: NCT02503267 Recruiting - Clinical trials for Congenital Heart Diseases

"Incidence and Consequences of Disorders of Glycosylation in Patients With Conotruncal and Septal Heart Defects"

(CARDIoG)
Start date: July 2015
Phase: N/A
Study type: Observational

The objective of the study is to investigate congenital disorders of glycosylation in congenital heart diseases without a clear molecular or genetic basis.