drugset / Trial / NCT03778554
Danish Trial of Beta Blocker Treatment After Myocardial Infarction Without Reduced Ejection Fraction
Phase 4
Active not recruiting
2760 enrolled
Bispebjerg Hospital
Aalborg University Hospital · collabAarhus University Hospital · collabAmager Hospital · collabBornholm Hospital · collabGentofte Hospital · collabGlostrup University Hospital, Copenhagen · collabHerlev Hospital · collabHolbaek Hospital · collabHospital of Southern Jutland · collabHospitalsenheden Midt · collabHospitalsenheden Vest · collabHvidovre University Hospital · collabNaestved Hospital · collabNordsjaellands Hospital · collabNykoebing Hospital · collabOdense University Hospital · collabRegionshospitalet Horsens · collabSilkeborg Sygehus · collabSlagelse Hospital · collabSvendborg Hospital · collabSydvestjysk Sygehus · collabSygehus Lillebaelt (Vejle and Kolding) · collabUniversity Hospital Bispebjerg and Frederiksberg · collabZealand University Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
To determine whether long-term treatment with oral betablocker therapy after myocardial infarction in patient with no heart failure reduces the composite outcome of recurrent MI, all-cause mortality, revascularisation with percutaneous coronary intervention or coronary artery bypass graft, ischemic stroke, incident heart failure, or malignant ventricular arrhythmia including resuscitated cardiac arrest of cardiac origin.
Timeline
- Start
- 2018-12-17
- Primary completion
- 2025-04-01
- Completion
- 2035-12-10
Outcome
Met primary endpoint
paper hazard ratio, 0.85; 95% confidence interval [CI], 0.75 to 0.98; P = 0.03 PMID 40888716 ↗
paper beta-blocker therapy led to a lower risk of death or major adverse cardiovascular events than no beta-blocker therapy. PMID 40888716 ↗
Publications
- Munkhaugen J, Kristensen AMD, Halvorsen S, Holmager T, Olsen MH, Bakken A, Sehested TSG, Ruddox V, Maeng M, Vikenes K, Jensen SE, Steigen T, Lambrechtsen J, Jortveit J, Bovin A, Schirmer H, Christiansen MK, Wiseth R, Mikkelsen D, Larsen AI, Lyngby Kjaergaard C, Andresen K, Gustafsson I, Tuseth V, Larsen ML, Deeg PS, Veien K, Bohmer E, Botker HE, Brattrud AO, Bronnum-Schou J, Pettersen AR, Bang LE, Oie E, Engstrom T, Borg EB, Kristensen K, Nymo SH, Gislason G, Vethe NT, Abdulla JAM, Dammen T, Mouridsen MR, Bendz B, Bertelsen MLN, Hove JD, Schierbeck L, Snoer M, Davidsen C, Egholm G, Thomsen KK, Jadou G, Poenaru M, Krarup NT, Bottcher M, Staehr PB, Zwisler AD, Edvardsen T, Torp-Pedersen C, Otterstad JE, Lange T, Fagerland MW, Atar D, Prescott E; BETAMI-DANBLOCK Investigators. Beta-Blockers after Myocardial Infarction in Patients without Heart Failure. N Engl J Med. 2025 Nov 13;393(19):1901-1911. doi: 10.1056/NEJMoa2505985. Epub 2025 Aug 30.
- Kristensen AMD, Bovin A, Zwisler AD, Cerquira C, Torp-Pedersen C, Botker HE, Gustafsson I, Veien KT, Thomsen KK, Olsen MH, Larsen ML, Nielsen OW, Hildebrandt P, Foghmar S, Jensen SE, Lange T, Sehested T, Jernberg T, Atar D, Ibanez B, Prescott E. 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. 2020 May 23;21(1):415. doi: 10.1186/s13063-020-4214-6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bisoprolol | Other / unclassified | 10 mg | Oral |
| Subject | Carvedilol | Other / unclassified | 50 mg | Oral |
| Subject | Metoprolol | Other / unclassified | 200 mg | Oral |
| Subject | Nebivolol | Other / unclassified | 10 mg | Oral |