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Heart Diseases clinical trials

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NCT ID: NCT02741115 Completed - Clinical trials for Single Ventricle Heart Disease

Fontan Udenafil Exercise Longitudinal Assessment Trial

FUEL
Start date: July 22, 2016
Phase: Phase 3
Study type: Interventional

This study will evaluate the clinical efficacy and safety of udenafil, an orally administered, potent and selective inhibitor of PDE5, versus placebo for the treatment of adolescent subjects who have undergone the Fontan procedure.

NCT ID: NCT02740621 Completed - Clinical trials for Coronary Heart Disease

The Impact of Opioids in Coronary Heart Disease

MIOP/TRAPS
Start date: January 2016
Phase:
Study type: Observational

In this study, the risk of opioid medications on coronary heart disease in adults is investigated. Patients with the necessity of a coronary angiography and control patients with a non-cardiac disease of the same hospital are inquired with a standardized questionnaire about demographic and clinical risk factors for heart attack. An impact of opioid medications on coronary heart disease is hypothesised (MIOP). In addition, all patients with coronary angiography should be consulted twice (after 3 and 6 months) to find out how many of these patients have developed a refractory angina pectoris (TRAPS).

NCT ID: NCT02737982 Completed - Myocardial Ischemia Clinical Trials

Sex and Gender Differences in Ischemic Heart Disease - Endocrine Vascular Disease Approach

EVA
Start date: April 2016
Phase:
Study type: Observational [Patient Registry]

The application of sex-gender medicine is strongly recommended by World Health Organization and other international organization. In fact, it is emerging that, although men and women are affected to the same cardiovascular diseases (CVD), however they have different risk factors, disease progression and response to pharmacological and not-pharmacological treatments. Consequentially, the identification of biomarkers and therapeutic approaches taking into account sex gender differences (SGD) is relevant to develop a really evidence-based medicine. With the aim of translate in clinical setting the more recently available basic research evidences on estrogens and androgens balance involvement in modulation of ischemia-reperfusion myocardial damage, the investigators planned to conduct a research study on patients, affected by suspected or known ischemic heart disease (IHD) undergoing angiography and/or percutaneous coronary interventions (PCI), aged more than 18 years of both sex in ratio 1:1. Thus, in this setting, the goals of this proposal are: 1. To assess the sex-gender difference in entity of microvascular reperfusion damage in patients with IHD undergoing urgent or elective PCI; 2. To evaluate estrogen/androgen-dependent and -independent effects in gender-related differences on myocardial ischemia reperfusion damage occurring during PCI; 3. To investigate the differences in terms of platelet biology between men and women affected by IHD undergoing urgent or elective PCI, matched for age and clinical cardiovascular and metabolic characteristics; 4. To verify sex-driven interplay between response to PCI procedure, platelet function, sex hormones and entity of reperfusion and myocardial damage, as well as, the impact on clinical outcomes during a 1-year follow up. This research study wants to explore and consequently elucidate biological mechanisms responsible for sex-based differences in vivo human models of ischemia reperfusion myocardial damage. Moreover, the investigators expected to clarify the impact of biological variables evaluated on clinical outcomes after reperfusion therapeutic intervention.

NCT ID: NCT02737969 Completed - Clinical trials for Structural Heart Disease

TEE/Angio Fusion Study

Start date: April 2016
Phase:
Study type: Observational

This is a pilot study of patients undergoing structural heart disease procedures that utilize TEE and fluoroscopic guidance at the New York University (NYU) Langone Medical Center. Patients in this study will undergo their procedure utilizing the TEE/Angio fusion software prototype. This protocol is primarily intended to ascertain the potential utility of the software prototype in the study population and to provide data and feedback to improve the workflow and algorithms of the prototype. As such, a primary outcome variable and statistical analysis plan have not been identified. However, procedural time, measures of radiation exposure (dose area product, total radiation dose, fluoroscopy time), degree of residual valvular regurgitation or paravalvular regurgitation as applicable, and complications will be recorded.

NCT ID: NCT02737644 Completed - Clinical trials for Congenital Heart Disease

Peri-conception Key Nutritional Factors and Congenital Heart Disease

PKNFCHD
Start date: March 2016
Phase:
Study type: Observational

The study is a nested case-control study and the purpose is to describe the status of key nutrients(eg.folic acid and vitamins) supplementation among pregnant women in Shanghai, to find out the association between the level of serum key nutrients during peri-conceptional period and the incidence of congenital heart defects (CHD) in newborn, and to provide better preconception care.

NCT ID: NCT02736344 Completed - Heart Disease Clinical Trials

BIONICS - Pharmacokinetics (PK) Trial

BIONICS
Start date: April 2016
Phase:
Study type: Observational

The BioNIR Ridaforolimus Eluting Coronary Stent System is a single use device/drug combination product comprising: - Stent - mounted Cobalt Chromium (CoCr) alloy based stent - Delivery System - Rapid Exchange (RX) Coronary System - Polymer matrix coating - Poly n-butyl methacrylate (PBMA) and polymer coating (CarboSil®) - Ridaforolimus drug - Chemical Abstracts Service (CAS) Registry Number: 572924-54-0 The product is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to lesions in vessels with reference diameters of 2.5mm to 4.25mm, including complex lesions.

NCT ID: NCT02734940 Terminated - Heart Diseases Clinical Trials

Multimodal Analgesia in Cardiac Surgery (Pilot Study)

Start date: July 11, 2016
Phase: Phase 4
Study type: Interventional

The investigators objective is to assess the effectiveness of an opioid sparing multimodal approach for enhancing the recovery in Cardiac Surgical patients. This model would use a combination of intravenous (Dexmedetomidine, Ketamine, Lidocaine) and Spinal (Morphine) drugs.

NCT ID: NCT02732691 Active, not recruiting - Clinical trials for Cardiovascular Diseases

JENAVALVE AS EFS TRIAL: Pericardial TAVR Aortic Stenosis Study

Start date: October 21, 2016
Phase: N/A
Study type: Interventional

To collect information about treatment for severe aortic stenosis (AS), which affects the aortic valve in the heart. Aortic stenosis is a narrowing of the aortic valve opening, which decreases blood flow from the heart and causes symptoms such as chest pain, fainting and shortness of breath. The preferred treatment for severe aortic stenosis is aortic valve replacement surgery.

NCT ID: NCT02732106 Active, not recruiting - Clinical trials for Chronic Heart Failure

Characterization of Adipose Derived Regenerative Cells (ADRCs) From Patients With Chronic Heart Disease

Start date: April 2013
Phase: N/A
Study type: Observational

Human adipose tissue is now recognized as an acceptable, highly abundant source of adipose-derived regenerative cells (ADRCs). ADRCs are a heterogeneous or mixed population of cells found in adipose tissue including adult stem cells, leukocytes, connective tissue and vessel-associated cells. Autologous adult regenerative cells are thought to promote healing of scarred or injured tissue. While the investigators are learning more about the exact mechanisms every day, it is believed that this heterogeneous population of cells influences the local environment via cell-to-cell signaling, immune modulation, and differentiation into other cell types. The use of ADRCs in the treatment of many different medical conditions (including cardiovascular disease, soft tissue defects, wound healing, and many more) is being evaluated in numerous clinical and preclinical studies around the world. While there is a considerable amount of information regarding the cellular composition of ADRCs isolated from healthy donors, basically there is no much data regarding the ADRC composition from cardiac patients. In this study, adipose tissue or cells from chronic heart ischemia patients, that would otherwise be thrown away in waste, will be provided to researchers who will study these cells with the objective to characterize ADRCs derived from patients with a heart disease and to compare if a heart disease state does impact ADRC cell composition.

NCT ID: NCT02731248 Recruiting - Clinical trials for Congenital Heart Disease

Pulse Oximeter Screening in Congenital Heart Disease

POX
Start date: April 2016
Phase: N/A
Study type: Observational

Pulse oximetry screening of newborn infants increases early detection of critical congenital heart disease and minimises the risk of circulatory collapse before surgery. This study provides an update on the implementation of pulse oximetry screening in Turkey