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Heart Diseases clinical trials

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NCT ID: NCT03014830 Completed - Atherosclerosis Clinical Trials

Alirocumab and Reverse Cholesterol Transport

Start date: June 1, 2017
Phase: Phase 1
Study type: Interventional

Alirocumab is an injectable treatment for elevated blood cholesterol. The hypothesis of this study is that it also increases cholesterol excretion from the body into the stool, a process sometimes called reverse cholesterol transport. A cholesterol metabolic study will be done before and after 6 weeks of alirocumab treatment. If alirocumab increases reverse cholesterol transport, it is possible that this action provides additional protection from cardiovascular disease.

NCT ID: NCT03014700 Completed - Clinical trials for Congenital Heart Disease

Fibrinogen Concentrate vs Cryoprecipitate

Start date: March 2016
Phase: Phase 4
Study type: Interventional

One of the most common hemostatic derangements in pediatric open- heart surgery is an acute acquired hypofibrinogenemia. This compromises fibrin clot generation and platelet aggregation, resulting in increased bleeding and allogenic blood transfusions. Currently, fresh frozen plasma and cryoprecipitate are used to supplement fibrinogen in pediatric cardiac patients. We propose that replacing cryoprecipitate with fibrinogen concentrate will be as effective in treating post-CPB bleeding and will decrease total blood product exposure when used as part of a blood transfusion algorithm. We plan to include all patients undergoing cardiac surgery on CPB less than 12 months and a fibrinogen level <250mg/dL while on bypass. We hope to demonstrate that fibrinogen concentrate is at least as effective as the standard of care in the management of peri- operative bleeding in neonatal patients undergoing cardiopulmonary bypass. If we are able to demonstrate that fibrinogen is at least as effective as the standard of care, then we would plan a multi-center trial to demonstrate the safety and efficacy of this medication. If we are able to demonstrate that fibrinogen concentrate is effective, fibrinogen concentrate could replace allogenic products and potentially decrease transfusion related morbidity in mortality in this population.

NCT ID: NCT03013751 Active, not recruiting - Clinical trials for Functional Single Ventricle Heart Disease

A Extension Study of Udenafil in Adolescents

FUELExten
Start date: January 2017
Phase: Phase 3
Study type: Interventional

This study is a 12-month (52 week) safety extension study to supplement the FUEL Phase III clinical trial to provide safety information regarding the long-term use of udenafil in adolescents with single ventricle congenital heart disease.

NCT ID: NCT03011775 Completed - Adverse Effect Clinical Trials

Effect of Pioglitazone on Insulin Resistance, Atherosclerosis Progression and Clinical Course of Coronary Heart Disease

EFFORT
Start date: November 2012
Phase: Phase 4
Study type: Interventional

Pioglitazone, a medication of thiazolidinedione group, is capable of triggering the peroxisome proliferator-activated receptors (PPAR-γ). Activation of receptor PPAR-γ regulates carbohydrate and lipid metabolism, immune and inflammatory responses in heart tissues. Our aim will to study the effect of pioglitazone on insulin resistance, the clinical course of atherosclerosis and coronary heart disease (CHD). The study will include 43 patients with coronary artery disease. Patients will be divided into the study group - 20 patients, in whom pioglitazone will be included in the combined therapy at a dose of 15 mg 1 time per day in the morning, and the control group - 23 patients receiving standard complex drug therapy over 6 months. Patients will be underwent clinical examination, ultrasound of neck vessels, study of carbohydrate and lipid metabolism. The end primary points of the study will be the onset of death due to myocardial infarction, coronary revascularization procedures (coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI)), or hospitalization for acute coronary syndrome (ACS) or unstable angina (UA). Predefined secondary end points included carotic atherosclerotic leisure (carotic intima-media thickness, diameter of stenosis, presents of atherosclerotic plaque), systemic inflammation level (the level of C reactive protein), lipid metabolism (levels of serum total cholesterol, triglycerides, high and low density lipoproteins), level of insulin resistance ( oral glucose tolerance test, blood glucose).

NCT ID: NCT03011697 Recruiting - Clinical trials for Valvular Heart Disease

Valvular Heart Disease Registry Study in Second Affiliated Hospital of ZheJiang University

VHD-ZJU
Start date: February 1, 2017
Phase:
Study type: Observational

We design a prospective, observational cohort study to provide contemporary information on the prevalence, characteristics, risk stratification,cost-effective ,treatments and prognosis of Chinese hospitalised adult patients with valvular heart disease.

NCT ID: NCT03007537 Terminated - Surgery Clinical Trials

The Prevention of Erythropoietin on Cardiac Surgery-associated Acute Kidney Injury

Start date: October 1, 2015
Phase: N/A
Study type: Interventional

To testify the prevention of Erythropoietin on cardiac surgery associated-acute kidney injury, and trying to provide evidence for protecting the renal function and improving the prognosis for patients after cardiac surgery.

NCT ID: NCT03006835 Not yet recruiting - Clinical trials for Coronary Heart Disease

Different Dosage of Domestic and Imported Clopidogrel on the Platelet Inhibition Ratio in Patients Undergoing PCI

Start date: January 2017
Phase: Phase 4
Study type: Interventional

This is a single-center, randomized, single-blind, investigator-initiated, pharmacological study with a parallel design. Patients with non-ACS undergoing primary percutaneous coronary intervention will be randomized after informed consent, in a 1:1:1:1 ratio to the following treatment groups: Group Α: Domestic Clopidogrel 300mg as a loading dose before PCI, followed by 75mg per day. Group B: Domestic Clopidogrel 600mg as a loading dose before PCI, followed by 75mg per day. Group B: Imported Clopidogrel 300mg as a loading dose before PCI, followed by 75mg per day. Group D: Imported Clopidogrel 600mg as a loading dose before PCI, followed by 75mg per day. Platelet inhibition ratio assessment by thrombelastogram will be performed,2 hours after the loading dose(Day 0), 6 hours after thrombelastogram (Day 0), 30 day after thrombelastogram. Documentation of major adverse cardiac events (death, myocardial infarction, stroke, revascularization procedure with PCI or CABG) and serious adverse events (bleeding, other adverse events)will be performed until Day 30.

NCT ID: NCT03005626 Completed - Clinical trials for Congenital Heart Diseases

Transition From Adolescents to Adulthood for Patients With Congenital Heart Diseases

Start date: January 2017
Phase: N/A
Study type: Interventional

The Investigators aim to measure the impact of a transition program in congenital cardiology in terms of health-related quality of life.

NCT ID: NCT02999438 Completed - Heart Failure Clinical Trials

Frailty in Children With Cardiac Disease

Start date: November 2016
Phase:
Study type: Observational

Frailty is a complex biologic syndrome of diminished physiologic reserve that leads to decreased resistance to stressors and is associated with adverse health outcomes. The syndrome has been well studied in adults and is quantified by the Fried criteria, which are comprised of five components- slowness, weakness, self-reported exhaustion, shrinkage and diminished physical activity. The concept of frailty is novel in children. A study in young adult childhood cancer survivors demonstrated increased incidence of frailty in this population along with increased risk of morbidity and mortality. This suggests that frailty as a phenotype has relevance outside of the geriatric age group. Pediatric patients with single ventricle physiology, heart failure and pulmonary artery hypertension- all represent populations with significantly increased risk of mortality, morbidity and decreased quality of life. Currently, such patients are monitored outpatient by serial echocardiograms and blood work that only gives information about end organ damage. But there is no validated tool available to measure global infirmity in such children. Better understanding of the relevance and applicability of frailty in pediatrics may allow for identification of the most vulnerable pediatric cardiac patients and be of value in optimizing their clinical management and improving health outcomes.

NCT ID: NCT02996903 Completed - Clinical trials for Coronary Artery Disease

Prospective Multicenter Registry On RadiaTion Dose Estimates Of Cardiac CT AngIOgraphy IN Daily Practice in 2017

PROTECTION-VI
Start date: March 1, 2017
Phase:
Study type: Observational [Patient Registry]

The "Prospective Multicenter Registry On RadiaTion Dose Estimates Of Cardiac CT AngIOgraphy IN Daily Practice in 2017" (PROTECTION-VI) study is a prospective registry and investigator-initiated initiative without third-party funding, which will collect and analyze the radiation dose exposure of Cardiac Computed Tomography Angiographic (CCTA) studies in current daily practice worldwide. Particularly, the study will assess the use of strategies for dose reduction during CCTA. A decade ago, the multicentre observational PROTECTION-I study has revealed that the dose-length-product of CCTA ranges between 568 - 1259 mGy x cm with a median of 885 mGy x cm. This corresponds to an estimated effective dose of approximately 12 mSv. Since then a variety of techniques have been developed and enhanced in order to reduce radiation exposure during CCTA. Recent studies demonstrated feasibility of dramatically reduced effective radiation doses during CCTA (0,1 - 0,3 mSv). This has been executed in small cohorts of patients at scientific expert centers. However, it remains unclear, if such low-level radiation dose exposure may be achieved in clinical routine and if diagnostic image quality is maintained. In order to analyze the magnitude of radiation dose exposure of CCTA in today's clinical practice and the current use of dose-saving techniques, we designed the PROTECTION-VI study. Eventually, this study may contribute to further improving radiation dose exposure for patients undergoing CCTA.