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
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Anna Meta Dyrvig Kristensen1, Ann Bovin2, Ann Dorthe Zwisler3
1Department of Cardiology, Bispebjerg University Hospital, Copenhagen, Denmark. anna.meta.dyrvig.kristensen.02@regionh.dk.
Insights
Beta-blocker therapy after myocardial infarction (MI) is recommended, but its benefit in patients without heart failure or reduced ejection fraction is unclear. The DANBLOCK trial will evaluate beta-blockers in this population to inform clinical guidelines.
Area of Science:
- Cardiology
- Clinical Trials
- Pharmacology
Background:
- Current beta-blocker recommendations post-myocardial infarction (MI) stem from older trials.
- These trials often included patients with heart failure or reduced left ventricular ejection fraction (LVEF ≤ 40%).
- The efficacy of beta-blockers in post-MI patients without these conditions remains uncertain.
Purpose of the Study:
- To evaluate the efficacy of long-term beta-blocker treatment in post-MI patients without reduced LVEF or heart failure.
- To provide evidence to inform future clinical guidelines regarding beta-blocker use after MI.
Main Methods:
- The DANBLOCK trial is a prospective, randomized, controlled, open-label trial.
- 3570 patients will be randomized within 14 days of MI to receive beta-blockers or control for at least 2 years.
- Primary endpoint is a composite of mortality, recurrent MI, heart failure, unstable angina, or stroke, assessed via local adjudication and national registers.
Main Results:
- This section is not applicable as the study is ongoing and results are not yet available.
Conclusions:
- The DANBLOCK trial will investigate long-term beta-blocker therapy in post-MI patients without heart failure and reduced LVEF.
- Results are expected to contribute significant scientific evidence to update clinical practice guidelines.
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.
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