Design and rationale of the Danish trial of beta-blocker treatment after myocardial infarction without reduced ejection fraction: study protocol for a randomized controlled trial

Trials

Borja Ibanez¹  Ann Dorthe Zwisler²  Mogens Lytken Larsen³  Svend Eggert Jensen³  Hans Erik Bøtker⁴  Anna Meta Dyrvig Kristensen⁵  Eva Prescott⁵  Ida Gustafsson⁵  Olav Wendelboe Nielsen⁵  Thomas Sehested⁵  Per Hildebrandt⁶  Sussie Foghmar⁷  Karsten Tange Veien⁸  Dan Atar⁹  Kristian Korsgaard Thomsen^1,10  Ann Bovin^1,11  Tomas Jernberg^1,12  Christian Torp-Pedersen^1,13  Michael Hecht Olsen^1,14  Theis Lange^1,15  Charlotte Cerquira^1,16 

[1] Centro Nacional de Investigaciones Cardiovasculares (CNIC) & IIS- Fundación Jiménez Díaz & CIBERCV;Danish Centre for Rehabilitation and Palliative Care, Odense University Hospital and University of Southern Denmark;Department of Cardiology, Aalborg University Hospital;Department of Cardiology, Aarhus University Hospital;Department of Cardiology, Bispebjerg University Hospital;Department of Cardiology, Frederiksberg Heart Clinic;Department of Cardiology, Hvidovre-Amager Hospital;Department of Cardiology, Odense University Hospital;Department of Cardiology, Oslo University Hospital;Department of Cardiology, Sydvestjysk Sygehus;Department of Cardiology, Sygehus Lillebælt;Department of Clinical Sciences, Division of Cardiology, Karolinska Institutet, Danderyd Hospital;Department of Epidemiology and Biostatistics, Aalborg University Hospital;Department of Internal Medicine, Holbæk Hospital;Section of Biostatistics, University of Copenhagen;The Regional Clinical Quality Development Program;

关键词: Myocardial infarction;    Beta-blocker treatment;    Long-term prognosis;    Randomized controlled trial;   

DOI  :  10.1186/s13063-020-4214-6

来源: DOAJ

【 摘 要 】

Abstract Background Treatment with beta-blockers is currently recommended after myocardial infarction (MI). The evidence relies on trials conducted decades ago before implementation of revascularization and contemporary medical therapy or in trials enrolling patients with heart failure or reduced left ventricular ejection fraction (LVEF ≤ 40%). Accordingly, the impact of beta-blockers on mortality and morbidity following acute MI in patients without reduced LVEF or heart failure is unclear. Methods/design The Danish trial of beta-blocker treatment after myocardial infarction without reduced ejection fraction (DANBLOCK) is a prospective, randomized, controlled, open-label, non-blinded endpoint clinical trial designed to evaluate the efficacy of beta-blocker treatment in post-MI patients in the absence of reduced LVEF or heart failure. We will randomize 3570 patients will be randomized within 14 days of index MI to beta-blocker or control for a minimum of 2 years. The primary endpoint is a composite of all-cause mortality, recurrent MI, acute decompensated heart failure, unstable angina pectoris, or stroke. The primary composite endpoint will be assessed through locally reported and adjudicated endpoints supplemented by linkage to the Danish national registers. A number of secondary endpoints will be investigated including patient reported outcomes and cardiovascular mortality. Data from similar ongoing trials in Norway and Sweden will be pooled to perform an individual patient data meta-analysis. Discussion DANBLOCK is a randomized clinical trial investigating the effect of long-term beta-blocker therapy after myocardial infarction in patients without heart failure and reduced LVEF. Results from the trial will add important scientific evidence to inform future clinical guidelines. Trial registration Clinicaltrials.gov, NCT03778554 . Registered on 19 December 2018. European Clinical Trials Database, 2018-002699-42 , registered on 28 September 2018.

【 授权许可】

Unknown