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
Abstract 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 le...
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| Format: | Article |
| Language: | English |
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BMC
2020-05-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-020-4214-6 |
| _version_ | 1819264269411155968 |
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| author | Anna Meta Dyrvig Kristensen Ann Bovin Ann Dorthe Zwisler Charlotte Cerquira Christian Torp-Pedersen Hans Erik Bøtker Ida Gustafsson Karsten Tange Veien Kristian Korsgaard Thomsen Michael Hecht Olsen Mogens Lytken Larsen Olav Wendelboe Nielsen Per Hildebrandt Sussie Foghmar Svend Eggert Jensen Theis Lange Thomas Sehested Tomas Jernberg Dan Atar Borja Ibanez Eva Prescott |
| author_facet | Anna Meta Dyrvig Kristensen Ann Bovin Ann Dorthe Zwisler Charlotte Cerquira Christian Torp-Pedersen Hans Erik Bøtker Ida Gustafsson Karsten Tange Veien Kristian Korsgaard Thomsen Michael Hecht Olsen Mogens Lytken Larsen Olav Wendelboe Nielsen Per Hildebrandt Sussie Foghmar Svend Eggert Jensen Theis Lange Thomas Sehested Tomas Jernberg Dan Atar Borja Ibanez Eva Prescott |
| author_sort | Anna Meta Dyrvig Kristensen |
| collection | DOAJ |
| description | Abstract 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. |
| first_indexed | 2024-12-23T20:26:48Z |
| format | Article |
| id | doaj.art-b2a595e6a6e1488cb7c02796601af971 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-23T20:26:48Z |
| publishDate | 2020-05-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-b2a595e6a6e1488cb7c02796601af9712022-12-21T17:32:21ZengBMCTrials1745-62152020-05-0121111110.1186/s13063-020-4214-6Design and rationale of the Danish trial of beta-blocker treatment after myocardial infarction without reduced ejection fraction: study protocol for a randomized controlled trialAnna Meta Dyrvig Kristensen0Ann Bovin1Ann Dorthe Zwisler2Charlotte Cerquira3Christian Torp-Pedersen4Hans Erik Bøtker5Ida Gustafsson6Karsten Tange Veien7Kristian Korsgaard Thomsen8Michael Hecht Olsen9Mogens Lytken Larsen10Olav Wendelboe Nielsen11Per Hildebrandt12Sussie Foghmar13Svend Eggert Jensen14Theis Lange15Thomas Sehested16Tomas Jernberg17Dan Atar18Borja Ibanez19Eva Prescott20Department of Cardiology, Bispebjerg University HospitalDepartment of Cardiology, Sygehus LillebæltDanish Centre for Rehabilitation and Palliative Care, Odense University Hospital and University of Southern DenmarkThe Regional Clinical Quality Development ProgramDepartment of Epidemiology and Biostatistics, Aalborg University HospitalDepartment of Cardiology, Aarhus University HospitalDepartment of Cardiology, Bispebjerg University HospitalDepartment of Cardiology, Odense University HospitalDepartment of Cardiology, Sydvestjysk SygehusDepartment of Internal Medicine, Holbæk HospitalDepartment of Cardiology, Aalborg University HospitalDepartment of Cardiology, Bispebjerg University HospitalDepartment of Cardiology, Frederiksberg Heart ClinicDepartment of Cardiology, Hvidovre-Amager HospitalDepartment of Cardiology, Aalborg University HospitalSection of Biostatistics, University of CopenhagenDepartment of Cardiology, Bispebjerg University HospitalDepartment of Clinical Sciences, Division of Cardiology, Karolinska Institutet, Danderyd HospitalDepartment of Cardiology, Oslo University HospitalCentro Nacional de Investigaciones Cardiovasculares (CNIC) & IIS- Fundación Jiménez Díaz & CIBERCVDepartment of Cardiology, Bispebjerg University HospitalAbstract 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.http://link.springer.com/article/10.1186/s13063-020-4214-6Myocardial infarctionBeta-blocker treatmentLong-term prognosisRandomized controlled trial |
| spellingShingle | Anna Meta Dyrvig Kristensen Ann Bovin Ann Dorthe Zwisler Charlotte Cerquira Christian Torp-Pedersen Hans Erik Bøtker Ida Gustafsson Karsten Tange Veien Kristian Korsgaard Thomsen Michael Hecht Olsen Mogens Lytken Larsen Olav Wendelboe Nielsen Per Hildebrandt Sussie Foghmar Svend Eggert Jensen Theis Lange Thomas Sehested Tomas Jernberg Dan Atar Borja Ibanez Eva Prescott 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 Myocardial infarction Beta-blocker treatment Long-term prognosis Randomized controlled trial |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Myocardial infarction Beta-blocker treatment Long-term prognosis Randomized controlled trial |
| url | http://link.springer.com/article/10.1186/s13063-020-4214-6 |
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