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
SN - 1745-6215
VL - 21
JO - Trials
JF - Trials
IS - 1
M1 - 415
ER -