TY - JOUR

T1 - Design and rationale of the Danish trial of beta-blocker treatment after myocardial infarction without reduced ejection fraction

T2 - Study protocol for a randomized controlled trial

AU - Kristensen, Anna Meta Dyrvig

AU - Bovin, Ann

AU - Zwisler, Ann Dorthe

AU - Cerquira, Charlotte

AU - Torp-Pedersen, Christian

AU - Bøtker, Hans Erik

AU - Gustafsson, Ida

AU - Veien, Karsten Tange

AU - Thomsen, Kristian Korsgaard

AU - Olsen, Michael Hecht

AU - Larsen, Mogens Lytken

AU - Nielsen, Olav Wendelboe

AU - Hildebrandt, Per

AU - Foghmar, Sussie

AU - Jensen, Svend Eggert

AU - Lange, Theis

AU - Sehested, Thomas

AU - Jernberg, Tomas

AU - Atar, Dan

AU - Ibanez, Borja

AU - Prescott, Eva

PY - 2020

Y1 - 2020

N2 - 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.

AB - 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.

KW - Beta-blocker treatment

KW - Long-term prognosis

KW - Myocardial infarction

KW - Randomized controlled trial

U2 - 10.1186/s13063-020-4214-6

DO - 10.1186/s13063-020-4214-6

M3 - Journal article

C2 - 32446298

AN - SCOPUS:85085456116

VL - 21

JO - Trials

JF - Trials

SN - 1745-6215

IS - 1

M1 - 415

ER -