Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
Download Study protocol NOAC
Document related concepts
Transcript
Research Plan New Oral Anticoaguants (NOACs) in Adults with Congenital Heart Disease (ACHD) - Insights from the Swiss ACHD Registry Applicant PD Dr. med. Daniel Tobler Department of Cardiology University hospital Basel Petersgraben 4 4031 Basel E-mail: [email protected] Phone: ++41 61 556 58 40 Fax: ++41 61 279 98 23 Co-Applicants PD Dr. med. Matthias Greutmann Departement of Cardiology University Heart Center Zurich Rämistrasse 100, 8091 Zürich – Switzerland Email: [email protected] Phone: +41 44 255 38 83 Fax : +41 44 255 87 01 Prof. Dr. med. Markus Schwerzmann Center for congenital heart disease Department of cardiology, Inselspital Freiburgstrasse 4 3010 Bern E-mail: [email protected] Phone: ++41 31 632 00 99 Fax: ++41 31 632 80 50 Background: Congenital heart disease is the most common birth defect affecting about 1% of all live births. Before surgical repair became available, infant mortality was high. With the advent of open heart surgery and improved pediatric care, childhood mortality has become uncommon and survival to adulthood is now expected. As a consequence, a rapidly increasing cohort of adult survivors has evolved. However, these adults are not cured. Many are at high risk of premature cardiac death as young adults. Their risk for cardiovascular complications is even much higher, with atrial arrhythmias being by far the most common complication. In one population based study, more than 50% of patients with severe congenital heart developed atrial arrhythmias by age 65 years. The new oral anticoagulants (NOACs) have become the treatment of choice to prevent cardio-embolic events in patients with non-valvular atrial fibrillations. Many patients with congenital heart disease and supraventricular tachycardia may also benefit from these drugs, but this population was underrepresented or not tested at all in the large NOAC trials. Therefore, it is unknown if and how many patients with congenital heart disease would benefit. Aim: To evaluate the frequency of ACHD patients in Switzerland with a formal indication for NOACs (nonvalvular atrial fibrillation); to analyze clinical characteristics of this cohort; to describe major outcomes of ACHD patients under current anticoaculation (NOACs versus Marcoumar). Methods: Between May 2014 – June 2016 patient data and detailed data on adverse cardiovascular events are prospectively collected for all patients enrolled into the Swiss national ACHD registry. All patients follwed at specialised ACHD clinics (University hospitals of Basel, Bern, Lausanne, Geneva and Zurich; and Kantonsspital St. Gallen , Lucerne and Klinik in Park) are asked to participate at their regular clinical follow-up. So far, more than 1600 patients haven been enrolled (May 2015). The registry is registered at www.clinicaltrials.gov. Data collection includes patients' age, main diagnosis, previous interventions and previous cardiac complications, type of arrhythmia, mode of arrhythmia therapy (ablation, cardioversion, drug therapy, no therapy) and mode of anticoaculation (name and dose of drug). Major cardiac outcomes of patients under current anticoagulation will be investigated prospectively. Outcome measures include death, stroke and major bleedings. Outcome measures: Relative (in comparison to the entire ACHD cohort) and absolute numbers of patients with a formal indication of NOACs within the studied cohort. Descriptions of patients' clinical characteristics and cardiac outcomes. Study Registration and Publication The registry is registered at www.clinicaltrials.gov. The study team will undertake all efforts necessary to publish the results of this study in a peer-reviewed medical journal. Time table May 2014 – ongoing Patient recruitment into Swiss registry for adults with congenital heart disease May 2014 – December 2016 Prospective data collection for cardiac outcomes January 2017 – March 2017 Analysis of dataset and manuscript preparation Requested positions Research fellow: Data entering into the Swiss registry 8000 sFr Basel, 04.05.2015 PD Dr. med. Daniel Tobler Department of Cardiology, University Hospital Basel
