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Heart Diseases clinical trials

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NCT ID: NCT03153137 Completed - Clinical trials for Congenital Heart Disease

Clinical Study Assessing the Efficacy and Safety of Macitentan in Fontan-palliated Subjects

RUBATO
Start date: August 14, 2017
Phase: Phase 3
Study type: Interventional

The primary objective is to assess the effect of macitentan 10 mg as compared to placebo on exercise capacity through cardiopulmonary exercise testing.

NCT ID: NCT03150953 Completed - Clinical trials for Congenital Heart Disease

Evaluation of a Novel Patient Warming System During MRI

Start date: May 26, 2016
Phase: N/A
Study type: Interventional

Patients under deep sedation and general anesthesia lose heat to their surrounding environment. Hypothermia after anesthesia is associated with worse patient outcomes, including increased number of infections and cardiovascular complications. Cardiac MRI scans performed for patients who require general anesthesia can cause a loss of body heat. Several mechanisms exist for reducing hypothermia under anesthesia including forced air warmers, fluid warmers, radiant warmers, and chemical warmers. Unfortunately, there are no MRI-compatible systems which allow patient warming and prevention of hypothermia in anesthetized patient in the MRI-scanner. This study is testing a non-invasive device that warms patients under clinically indicated general anesthesia in the MRI scanner. This device will keep in the heat made by the MRI scanner.

NCT ID: NCT03146143 Completed - Clinical trials for Congenital Cardiac Disorders

Ultrafiltration Effect on Extravascular Lung Water in Pediatric Cardiac Surgery

Start date: May 15, 2017
Phase: N/A
Study type: Interventional

study will assess the effect the ultrafiltration after pediatric congenital heart surgery on cardiopulmonary bypass. patients will be divided into two groups. first group will receive ultrafiltration and the second group will be control group without filtration. we will assess extravascular lung water by lung ultrasound, arterial oxygen tension and duration of ventilation.

NCT ID: NCT03144258 Completed - Clinical trials for Congenital Heart Disease

Evaluation of the Microcirculation During the Corrective Surgery of Congenital Heart Defects in Children

Start date: February 20, 2018
Phase:
Study type: Observational

General objective of the research project: To evaluate the alterations of systemic microvascular reactivity during cardiopulmonary bypass (CPB), in children submitted to cardiac surgery for repair of congenital heart defects.

NCT ID: NCT03144011 Completed - Clinical trials for Cardiopulmonary Bypass

Acute Kidney Injury in Children After Cardiopulmonary Bypass

Start date: February 8, 2017
Phase:
Study type: Observational

Acute kidney injury (AKI) is a common complication in patients with congenital heart defects after cardiopulmonary bypass. The death rate from AKI in critically ill children remains high and reaches 60%. The basic criteria for diagnosing and assessing the severity of kidney injury until recently were the level of serum creatinine and the amount of urine released. However, it should be noted that the level of serum creatinine, traditionally used to assess renal function, does not significantly increase until a decrease of more than 50% of the glomerular filtration rate, in addition, its level depends also on some extrarenal causes. Artificial blood circulation and hemodilution leads to the preservation of the level of creatinine at sufficiently low levels up to 1-3 days postoperative period. The level of diuresis as well as the level of creatinine is a nonspecific criterion after cardiac surgery and depends on several factors. Currently, in the field of acute renal injury studies, progress has been made in the emergence of new biomarkers such as the tissue inhibitor metalloproteinase-2 (TIMP-2) and insulin-like growth factor binding globulin-7 (IGFBP7), which are early markers of acute renal damage. In a study in adult patients, it was shown that the levels of TIMP-2 and IGFBP7 increased In the first 24-48 before the diagnosis of IR-associated renal damage. Among pediatric patients with congenital heart defects, such studies are single and only present for the age group 3 and older, which also demonstrated the high specificity and prognostic significance of these biomarkers in the early diagnosis of acute renal damage. It should also be noted that, in spite of the high specificity of the markers described, it is also necessary to note their considerable cost. Thus, taking into account the above, it is planned to compare and identify the relationship of these indicators with such parameter as the index of renal vascular resistance, the increase of which in the pre- and postoperative period may serve as a sign of the beginning acute renal injury.

NCT ID: NCT03138603 Completed - Heart Diseases Clinical Trials

Metoprolol to Reduce Perioperative Myocardial Injury

ORION
Start date: December 2016
Phase: Phase 3
Study type: Interventional

The purpose of this research study is to test if a commonly used, FDA-approved medication, called metoprolol, given at the conclusion of anesthesia following surgery, and during postoperative admission, reduces the possibility of heart related complications in patients with coronary artery disease (CAD).

NCT ID: NCT03136835 Completed - Clinical trials for Hypoplastic Left Heart Syndrome

Maternal Hyperoxygenation in Congenital Heart Disease

MATCH
Start date: February 2, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

A pilot study investigating the safety and feasibility of chronic maternal hyperoxygenation in the setting of fetal congenital heart disease

NCT ID: NCT03133689 Completed - Clinical trials for Coronary Heart Disease

Alcohol Consumption and Coronary Heart Disease Onset

Start date: March 1, 2017
Phase: N/A
Study type: Observational

The primary aim of this study is to examine if long-term patterns of alcohol consumption are associated with time-to-onset for incident coronary heart disease (fatal and non-fatal), using data from multiple cohorts.

NCT ID: NCT03125772 Completed - Type 2 Diabetes Clinical Trials

Trial on Safety & Performance of TAXUS Element vs. XIENCE Prime Stent in Treatment of Coronary Lesion in Diabetics

Tuxedo
Start date: June 2011
Phase: N/A
Study type: Interventional

The TUXEDO-India is a prospective, single blind, multi-center randomized clinical trial to assess the TAXUS Element™ in a consecutive population of diabetic patients with coronary artery disease undergoing coronary revascularization. Approximately 1,830 patients with single or multi lesion, multi vessel coronary artery or saphenous vein graft disease ranging in vessels ranging from 2.25 mm to 4.0 mm in diameter by visual estimate will be enrolled in a 1:1 randomization to TAXUS Element™ vs. XIENCE™ Prime in India at up to 50 clinical sites, to demonstrate the safety and effectiveness of TAXUS Element™ in an unrestricted population. Procedural Endpoints: - Device success, defined as attainment of < 30% residual stenosis of the target lesion (visual assessment) using the TAXUS Element™ or XIENCE™ Prime stent. - Lesion success defined as attainment of < 30% residual stenosis (visual assessment) using any percutaneous method. - Procedure success defined as lesion success without the occurrence of in-hospital MACE. - Procedure complication rate including composite and individual angiographic occurrence of dissection ≥B, distal embolization, no reflow, slow flow, abrupt closure, or perforation.

NCT ID: NCT03119090 Completed - Clinical trials for Congenital Heart Disease

Fontan Imaging Biomarkers (FIB) Study

FIB
Start date: September 2015
Phase:
Study type: Observational

The goal of the Fontan Imaging Biomarkers (FIB) study is to identify the associations of blood and urine biomarkers to imaging parameters of ventricular mechanics.