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Trials
Published in: Trials 1/2020

Open Access 01-12-2020 | ß-Blockers | Study protocol

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

Authors: Anna Meta Dyrvig Kristensen, Ann Bovin, Ann Dorthe Zwisler, Charlotte Cerquira, Christian Torp-Pedersen, Hans Erik Bøtker, Ida Gustafsson, Karsten Tange Veien, Kristian Korsgaard Thomsen, Michael Hecht Olsen, Mogens Lytken Larsen, Olav Wendelboe Nielsen, Per Hildebrandt, Sussie Foghmar, Svend Eggert Jensen, Theis Lange, Thomas Sehested, Tomas Jernberg, Dan Atar, Borja Ibanez, Eva Prescott

Published in: Trials | Issue 1/2020

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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.
Appendix
Available only for authorised users
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Metadata
Title
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
Authors
Anna Meta Dyrvig Kristensen
Ann Bovin
Ann Dorthe Zwisler
Charlotte Cerquira
Christian Torp-Pedersen
Hans Erik Bøtker
Ida Gustafsson
Karsten Tange Veien
Kristian Korsgaard Thomsen
Michael Hecht Olsen
Mogens Lytken Larsen
Olav Wendelboe Nielsen
Per Hildebrandt
Sussie Foghmar
Svend Eggert Jensen
Theis Lange
Thomas Sehested
Tomas Jernberg
Dan Atar
Borja Ibanez
Eva Prescott
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-4214-6

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