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Heart Diseases clinical trials

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NCT ID: NCT01668264 Not yet recruiting - Clinical trials for Congenital Heart Disease

Imaging Assessment of Diastolic Function

Start date: n/a
Phase: Phase 2
Study type: Interventional

Diastolic function is poorly studied in children with congenital heart disease. This is mainly due to the lack of validated techniques. Cardiac MRI offers two advantages compared to echocardiography: 1. accurate measurements of ventricular volumes and mass; 2. tissue characterization. The main advantage of echocardiography is a better temporal resolution which allows the study of short events like early relaxation. Overall there is a lack of studies correlating different echocardiographic and MRI parameters of heart function in pediatric populations with congenital or acquired heart diseases. This study will address specific questions on specific groups of patients that might bring more insight into chamber interaction and cardiac function. This study hypothesizes the following: - Atrial enlargement is a marker of chronic increase in filling pressures and 3D echo might be the best method for follow-up. - Cardiac remodeling associated with chronic loading results in changes in diastolic properties related to changes in cardiac mass and volume. This is related to changes in cardiac mechanics influencing diastolic parameters. Especially the influence on twisting and untwisting will be studied. - Regional myocardial fibrosis and scarring may account for regional systolic and diastolic dysfunction with possible prognostic impact

NCT ID: NCT01624818 Not yet recruiting - Heart Disease Clinical Trials

Active With Heart Disease

Start date: March 2013
Phase: Phase 0
Study type: Interventional

Background: In Norway each year 130-150 children are born with heart disease that requires lifelong medical follow-up. Children with heart defects have reduced motor skills and reduced physical capacity compared with healthy peers. Increased knowledge in the children themselves and the general public, along with psychosocial interventions improve the child's ability to cope with the consequences of their disease. Descriptions of the experiences that Norwegian children with heart disease and their parents have about participation in rehabilitation programs is limited. Geilomo children's hospital has 75 years experience in rehabilitation of children with chronic illness, and started in 2005 to welcome children with heart disease. At present there is no rehabilitation institutions in Norway that has a special group programs for children with heart disease. Geilomo want to establish such a group for children aged 6-7 years and 11-12 years. Main objective: The investigators will use of methods to learn more about the following: Study 1: The purpose is to generate knowledge about how children with heart disease and their relatives experience participation in a rehabilitation program at Geilomo children's hospital. Overarching question: How do children with heart disease and their guardians to participate in a rehabilitation program, and the impact of this on their daily life afterwards? Study 2: The purpose is to help a) to give the children an increased level of activity in the home environment. Question: Will children with heart disease increase their activity levels at home after a stay at Geilomo? 2b) for the children to improve their physical fitness. Question: Will children with heart disease have improved their physical condition three months after a stay at Geilomo? Work schedule: The project will have a duration of 3 years. The project will seek approval of the Regional Committee for Medical Research Ethics in May 2012. Interview Guide, information sheet and consent form has been prepared. Data collection for the study 2AB can start in March 2013. The first interviews will be conducted after 3 months, in June 2013. Data collection is expected to be completed in December 2013. The analysis will take place in parallel with the interview work. In 2014 and 2015 completed the writing of articles (3 pieces) and publication of results. Method: In order to shed light on the problem in study 1, the investigators will use semi-structured interview. 16 children and 16 parents to be interviewed after 3 months. Study 2a) To get information about their child's activity level in the home environment the investigators will use structured questionnaires. It is one form for children (36 persons) and another form for their parents (36 persons). Study 2b) All children (36 persons) conducting physical fitness test at the first visit and after three months. Children can be referred from across the country via the referral form. Dr. Henrik Holm (OUS) and Dr. Asle Hirth (HUS) determines participation according to inclusion and exclusion criteria. Parents submit a written consent on behalf of themselves and their children. Scientific significance: This application describes two related studies, both of which are expected to provide important information that can provide better services for children with heart disease.

NCT ID: NCT01534221 Not yet recruiting - Clinical trials for Ischemic Heart Disease

The COOPerative Establishment for Necessary Investigation in Clinical Outcome After Stenting

COPERNICOS
Start date: March 2012
Phase: Phase 4
Study type: Interventional

The superiority of a percutaneous coronary intervention (PCI) by one stent over another in terms of clinical outcome is usually documented in large randomized controlled trials (RCT). Although generated from selected study populations these data form the basis for evidence based practice (EBP) in the entire population of patients considered for coronary intervention. An inherent limitation of this approach is that study populations differ significantly from all comers in terms of patient characteristics and prognosis undermining the foundation for extrapolation of trial results to all comers. Furthermore, other trials are based on a "one-fits-all" concept, while the benefits of an "individual-tailored" approach that might be superior, is not investigated. The Purpose of the current study is to - Compare clinical outcome between several CE marked drug eluting stents - Compare clinical outcome between several CE marked bare metal stents - Compare clinical outcome in all comers with that of the selected study population of RCT's - Evolve methods to compare clinical outcomes between the generalized "one-fits-all" versus the individualized or "individual-tailored" stent selection approaches The Method employed is - All comer PCI registry - single centre - Randomisation of all eligible patients within the registry to one of several study stent - Quality assurance in non-randomized population within the registry by periodical alternating the institutional standard stent - Continuous follow up of all patients included the registry by means of systematic event detection and classification by an independent safety and end point committee - Assessment of effects on quality of life by heart and health questionnaires Outcome Measures Primary endpoints: - Composite of cardiac death, acute myocardial infraction and target vessel revascularisation - Stent thrombosis - A specifically developed Treatment Failure Rate classification Secondary outcome measures include each of the above, target lesion revascularisation and total death analyzed in a hierarchical fashion at 2, 3, 4 and 5 years. Tertiary outcome measure is self reported quality of life based on health questionnaires on general health and cardiac symptoms. Power Calculations An event rate of 20% within 5 years, a relative difference of 25% (an absolute difference of 5%), P< 5%, Power > 80% => 900 patients in each of two treatment arms. Prespecified Analysis include 1. The MACE rates between stent types 2. The Stent thrombosis rates between stent types 3. The Treatment failure rates between stent types 4. The randomized population versus non-randomized population 5. The individualized versus the generalized Population 6. QOL between stent types

NCT ID: NCT01495520 Not yet recruiting - Clinical trials for Ischemic Heart Disease

Ranolazine for Improving Symptoms of Palpitations

RYPPLE
Start date: January 2014
Phase: Phase 4
Study type: Interventional

Patients with ischemic heart disease often report multiple symptoms, including angina and palpitations. Ranolazine has antiarrhythmic effects which are largely a result of the drug's effect on multiple ion channels. It remains unknown, however, whether the favorable effects of ranolazine on symptoms and arrhythmias are maintained over time. Aim of this study is to test the hypothesis that chronic treatment with ranolazine can improve the symptomatic status of patients with ischemic heart disease by reducing the occurrence of palpitations.

NCT ID: NCT01442350 Not yet recruiting - Clinical trials for Fabry Disease, Cardiac Variant

Myocardial Affectation in Patients With Fabry Disease Without Phenotypic Manifestation. Diagnostic Value of Biomarkers

FAMY
Start date: October 2011
Phase: N/A
Study type: Observational

The cardiac variant of the Fabry disease is a rare cardiomyopathy affecting 1/50000 individuals in general population. It is generally diagnosed in advanced stages of the disease, because it presents clinical features very similar to the hypertrophic cardiomyopathy ones, making difficult the correct diagnosis. In Fabry disease there is a remodeling process of the myocardial interstitium and apoptosis of myocytes which leads to fibrosis development and later systolic dysfunction. The investigators propose to evaluate the utility of several biomarkers in the diagnosis of this cardiomyopathy, to facilitate the early diagnosis, which is clue to establish early enzyme replacement therapy or intensify the patients' follow up. In order to achieve this objective, the investigators will analyze markers of endothelial dysfunction, fibrosis and apoptosis in peripheral blood samples of patients carrying the mutation but without clinical manifestations and the investigators will compare their levels with dose obtained from two different control groups: diagnosed patients presenting clinical manifestations or index cases and healthy controls without carrying the mutation.

NCT ID: NCT01278771 Not yet recruiting - Clinical trials for Congenital Heart Disease

Coronary Anomalies in Congenital Heart Disease

CHD
Start date: March 2011
Phase: N/A
Study type: Observational

This is a retrospective study. The investigators shall review the angiography data of 1200 consecutive cardiac catheterizations of children and babies with CHD (Congenital Heart Disease) since 1998 till now. Coronary artery origin and course will be evaluated in relation to the morphologic cardiac anomalies. Coronary artery anomalies will be described and statistical analysis will be performed.

NCT ID: NCT01234181 Not yet recruiting - Clinical trials for Myocardial Infarction (MI) or Acute Myocardial Infarction (AMI)

Clinical Study of Hypoxia-Stressed Bone Marrow Mononuclear Cell Transplantation to Treat Heart Diseases

CSHSBMMCTTHD
Start date: November 2010
Phase: N/A
Study type: Interventional

The purpose of this study, is to determine the differences of clinical outcomes between hypoxic pre-treatment group and control group in bone marrow stem cell transplantation (BM-SCT) to treat acute myocardial infarction (AMI); and to evaluate the safety of both treatments. Heart failure patients underwent PCI treatment after AMI and with informed consent, are randomized allocation into hypoxic pre-treated BM-SCT group, normoxic pre-treated BM-SCT group, and control group. Cell resuspension is intracoronary injected into patients receiving coronary angiography, IL-6, CRP, TNF and BNP are detected; echocardiography, cardiac MRI and ECT are analyzed to evaluate heart function and alive myocardial cells. Holter's ECG monitor is employed to observe arrhythmia and embolism. We hypothesize that, by receiving hypoxic pre-treated BM-SCT, impaired heart function will be reversed in heart failure patients.

NCT ID: NCT01154998 Not yet recruiting - Clinical trials for Idiopathic Pulmonary Fibrosis

Case-Control Study of Fibrotic Interstitial Lung Disease (ILD) and Cardiac Disease / Interventions.

Start date: July 2010
Phase: N/A
Study type: Observational

There is a rare condition causing scarring of the lungs termed interstitial lung disease. This comprises a group of conditions which can be divided into separate diseases. The aim of this study is compare a group of patients (the cases) with 2 types of this disease (fibrotic non-specific interstitial pneumonia (NSIP) and idiopathic pulmonary fibrosis (IPF)) with patients without the disease. The study will look at the 2 groups and their exposures to factors such as medications, smoking, previous jobs, previous medical problems and specifically heart disease and any operations or procedures involving the heart. There have been previous studies showing a link between heart disease and scarring of the lungs. This study will look at whether this association is stronger in one or the other type of lung scarring diseases.

NCT ID: NCT00641290 Not yet recruiting - Clinical trials for Ischemic Heart Disease

Vigileo FloTrac vs Pulmonary Artery Catheter

Start date: April 2008
Phase: N/A
Study type: Observational

To study the role of Vigileo monitor using the FloTrac sensor to measure cardiac output using the pulse contour analysis as well as central venous oxygen saturation monitoring as a guide for tissue perfusion. The accuracy of the Vigileo monitoring was compared with the conventional thermodilution method for measuring cardiac output using the pulmonary artery catheter and mixed venous oxygen saturation for assessing global tissue perfusion.

NCT ID: NCT00117936 Not yet recruiting - Coronary Disease Clinical Trials

Fibroblast Growth Factor-1 (FGF-1) for the Treatment of Coronary Heart Disease

Start date: March 2020
Phase: Phase 2
Study type: Interventional

Treatment for no-option heart patients with coronary artery disease. Procedure includes the injection into the heart of a protein growth factor, administered by the Biological Delivery Systems MyoStar injection and mapping catheters, to stimulate the growth of blood vessels around blocked coronary arteries.