Danish Trial of Beta Blocker Treatment After Myocardial Infarction Without Reduced Ejection Fraction

NCT03778554 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: 2018-002699-42
• Study Type: interventional
• Target: 2,760
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Myocardial Infarction; Non-ST Elevation Myocardial Infarction (nSTEMI); ST Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• A composite of all-cause mortality, recurrent MI, revascularisation with PCI or CABG, ischemic stroke, incident heart failure, or malignant ventricular arrhythmia including resuscitated cardiac arrest of cardiac origin.

  Time to the composite of all-cause mortality, recurrent MI, revascularisation with PCI or CABG, ischemic stroke, incident heart failure, or malignant ventricular arrhythmia including resuscitated cardiac arrest of cardiag origin on an intention to treat analysis. The composite outcome will be assessed through nationwide registries and adjudicated by an independent Clinical Endpoint Adjudication Committee.

  Estimated follow-up min 6 months - max 6.25 years

Secondary Outcomes (23)

• Recurrent myocardial infarction

  Estimated follow-up min 6 months - max 6.25 years

• All-cause mortality

  Estimated follow-up min 6 months - max 6.25 years

• Malignant ventricular arrhythmias

  Estimated follow-up min 6 months - max 6.25 years

• Incident heart failure (diagnosed at hospitalization or at out-patient visits)

  Estimated follow-up min 6 months - max 6.25 years

• Unplanned coronary revascularization

  Estimated follow-up min 6 months - max 6.25 years

Study Arms (2)

Beta blocker treatment

EXPERIMENTAL

Treatment with beta blockers plus standard of care. Type and dosage according to treating cardiologist choice * Bisoprolol up to a total dose of 10 mg daily * Carvedilol up to a total dose of 50 mg daily * Metoprolol succinate up to a total dose of 200 mg daily * Nebivolol up to a total dose of 10 mg daily

Drug: Metoprolol Succinate; Drug: Bisoprolol; Drug: Carvedilol; Drug: Nebivolol

No beta blocker treatment

NO INTERVENTION

Standard care without beta blocker treatment

Interventions

Metoprolol Succinate DRUG

Eligible patients randomized to receive long-term therapy with oral beta-blockade

Beta blocker treatment

Bisoprolol DRUG

Eligible patients randomized to receive long-term therapy with oral beta-blockade

Beta blocker treatment

Carvedilol DRUG

Eligible patients randomized to receive long-term therapy with oral beta-blockade

Beta blocker treatment

Nebivolol DRUG

Eligible patients randomized to receive long-term therapy with oral beta-blockade

Beta blocker treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Left ventricular ejection fraction \> 40%
• Myocardial infarction (MI) within previous two weeks
• The diagnosis of acute MI must meet the Universal European Society of Cardiology (ESC) definition of MI

You may not qualify if:

• Clinical evidence of heart failure at the time of discharge
• Pregnancy or of child bearing age not using safe anticonception throughout the study period
• Lack of signed informed consent and expected cooperation during follow-up
• Any medical condition where beta blocker treatment is indicated according to the treating physician

Sponsors & Collaborators

• Bispebjerg Hospital: lead
• Amager Hospital: collaborator
• University Hospital Bispebjerg and Frederiksberg: collaborator
• Bornholm Hospital: collaborator
• Gentofte Hospital: collaborator
• Glostrup University Hospital, Copenhagen: collaborator
• Herlev Hospital: collaborator
• Hvidovre University Hospital: collaborator
• Nordsjaellands Hospital: collaborator
• Holbaek Hospital: collaborator
• Nykoebing Hospital: collaborator
• Naestved Hospital: collaborator
• Zealand University Hospital: collaborator
• Slagelse Hospital: collaborator
• Odense University Hospital: collaborator
• Svendborg Hospital: collaborator
• Sydvestjysk Sygehus: collaborator
• Hospital of Southern Jutland: collaborator
• Sygehus Lillebaelt (Vejle and Kolding): collaborator
• Aarhus University Hospital: collaborator
• Hospitalsenheden Midt: collaborator
• Hospitalsenheden Vest: collaborator
• Regionshospitalet Horsens: collaborator
• Silkeborg Sygehus: collaborator
• Aalborg University Hospital: collaborator

Study Sites (1)

Bispebjerg Hospital, Dept. of Cardiology Y builing 67, 1.floor, Bispebjerg Bakke 23

Copenhagen, 2400, Denmark

Location

Related Publications (2)

• 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.

  PMID: 40888716 DERIVED

• 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.

  PMID: 32446298 DERIVED

MeSH Terms

Conditions

Non-ST Elevated Myocardial Infarction; ST Elevation Myocardial Infarction

Interventions

Metoprolol; Bisoprolol; Carvedilol; Nebivolol

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring; Ethanolamines; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring

Study Officials

• Eva IB Prescott, MD, DMsC

  Bispebjerg Frederiksberg University Hospital

  PRINCIPAL INVESTIGATOR

• Anna Meta D Kristensen, MD

  University Hospital Bispebjerg and Frederiksberg

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Model Details: Prospective, randomized, controlled, open-label, blinded endpoint (PROBE design)

Study Record Dates

• First Submitted: December 10, 2018
• First Posted: December 19, 2018
• Study Start: December 17, 2018
• Primary Completion: April 1, 2025
• Study Completion (Estimated): December 10, 2035
• Last Updated: June 10, 2025

Record last verified: 2025-06

Locations

DK (1)