Evaluation of Decreased Usage of Betablockers After Myocardial Infarction in the SWEDEHEART Registry (REDUCE-SWEDEHEART)

March 4, 2024 updated by: Dr. Tomas Jernberg, Karolinska Institutet

Randomized Evaluation of Decreased Usage of betablocCkErs After Myocardial Infarction in the SWEDEHEART Registry - A Registry-based, Randomized, Parallel, Open-label, Multicenter Trial (REDUCE-SWEDEHEART)

Long-term beta-blocker therapy has not been investigated in contemporary randomized clinical trials in patients with myocardial infarction and normal heart function. The aim of this study is to determine whether long-term treatment with oral beta-blockade in patients with myocardial infarction and preserved left ventricular systolic ejection fraction reduces the composite of death of any cause or new myocardial infarction..

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

REDUCE-SWEDEHEART is designed as a registry-based, randomized, parallel, open-label, multicenter trial.

Patients, day 1-7 after myocardial infarction, who have undergone a coronary angiography and with preserved left ventricular systolic ejection fraction will be randomized to either oral beta-blockade (see "Intervention" for detailed description) at a dose according to the treating physician, or no beta-blockade. To allow quick inclusion the randomization module will be accessible by a simple web-based log-in procedure. Concomitantly, all baseline data about each individual patient will be collected from the SWEDEHEART registry. Patients will then be followed regarding all-cause mortality, myocardial infarction, heart failure, atrial fibrillation, and patient-related outcome measures (for a subgroup of patients). Patients that are eligible but not included in REDUCE-SWEDEHEART will also be followed regarding chosen treatment and the primary and secondary endpoints.

Follow-up will continue until 379 primary endpoints have been observed (endpoint driven). All analyses will be performed on the intention-to-treat set, defined as all intentionally randomized patients, by randomized treatment. The primary endpoint is death or new MI. Information about death will be obtained from the Swedish population registry. Information regarding new myocardial infarction during hospitalization and readmission because of myocardial infarction or other outcome (secondary outcomes, see section below), will be obtained from the SWEDEHEART-registry (for myocardial infarction) and the patient registry of the National board of health and welfare.

Study Type

Interventional

Enrollment (Estimated)

5000

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Sweden
    • Stockholms Län
      • Danderyd, Stockholms Län, Sweden, 182 88
        • Danderyd Hospital, Cardiac Intensive Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age≥18 years.
  2. Day 1-7 after MI as defined by the universal definition of MI, type 1, included in the SWEDEHEART registry.
  3. Undergone coronary angiography during hospitalization.
  4. Obstructive coronary artery disease documented by coronary angiography, i.e. stenosis ≥ 50 %, FFR ≤ 0.80 or iFR ≤ 0.89 in any segment at any time point before randomization.
  5. Echocardiography performed after the MI showing a normal ejection fraction (EF≥50%).
  6. Written informed consent obtained.

Exclusion Criteria:

  1. Any condition that may influence the patient's ability to comply with study protocol.
  2. Contraindications for beta-blockade
  3. Indication for beta-blockade other than as secondary prevention according to the treating physician.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oral beta-blocker treatment
Patients randomized to beta-blockade will be prescribed oral beta-blocker (metoprolol succinate or bisoprolol) at a dose according to the treating physician. Metoprolol succinate will be strongly recommended as first choice. Bisoprolol will be allowed as an alternative. Atenolol (or any other beta-blocker therapy) will not be allowed. The treating physician will be encouraged to aim for a dose of ≥ 100 mg for metoprolol succinate and ≥ 5 mg for bisoprolol. Prescribed treatment and dosing will be registered. Initiation (whether the prescribed drug is dispensed) and adherence (defined as proportion of prescribed tablets that are dispensed), and persistence (time on treatment) will also be recorded via the Drug prescription registry.
Drug: Metoprolol Succinate
Eligible patients randomized to active treatment will receive long-term oral beta-blockade (metoprolol succinate or bisoprolol).
Drug: Bisoprolol
Please see the section above.
No Intervention: No beta-blocker treatment
Patients randomized to no beta-blockade will be discouraged to use beta-blockade as long as there is no other indication than strictly secondary prevention after myocardial infarction. Patients assigned to no beta-blockade also receive best evidence-based care, without beta-blockers. For blood pressure control, other drugs than beta-blockers will be recommended as first-line treatment. Regarding later use of beta-blockade, follow up is performed in the Drug prescription registry. Patients will be asked to provide future physicians with the written information about the study when beta-blockade treatment is discussed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to the composite of death of any cause or MI
Time Frame: through study completion, an average of 3 year
Time to the composite of death of any cause or MI on an intention to treat basis (ITT)
through study completion, an average of 3 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause death
Time Frame: through study completion, an average of 3 year
Time to the individual component of the primary endpoint of any cause of death.
through study completion, an average of 3 year
Myocardial infarction
Time Frame: through study completion, an average of 3 year
Time to the individual component of the primary endpoint of MI.
through study completion, an average of 3 year
Cardiovascular death
Time Frame: through study completion, an average of 3 year
Time to cardiovascular death.
through study completion, an average of 3 year
Heart failure
Time Frame: through study completion, an average of 3 year
Time to hospital readmission due to heart failure (primary [main] diagnosis)
through study completion, an average of 3 year
Atrial fibrillation
Time Frame: through study completion, an average of 3 year
Time to hospital readmission due to atrial fibrillation (primary [main] diagnosis)
through study completion, an average of 3 year
Bradycardia, Advanced AV-block, hypotension, syncope or need for pacemaker
Time Frame: through study completion, an average of 3 year
Time to hospital readmission due to bradycardia or advanced AV-block or hypotension or syncope or need for pacemaker (primary [main] diagnosis)
through study completion, an average of 3 year
Asthma or Chronic Obstructive Pulmonary Disease
Time Frame: through study completion, an average of 3 year
Time to hospital readmission due to asthma or chronic obstructive pulmonary disease (primary [main] diagnosis)
through study completion, an average of 3 year
Stroke
Time Frame: through study completion, an average of 3 year
Time to hospital readmission due to stroke (primary [main] diagnosis)
through study completion, an average of 3 year
Health related quality of life (HRQOL)
Time Frame: Estimated maximal follow-up for each patient for this outcome is 1 year.
Health related quality of life (HRQOL) measured by EQ-5D in patients younger than 75 years of age
Estimated maximal follow-up for each patient for this outcome is 1 year.
Health care costs
Time Frame: through study completion, an average of 3 year
Health care cost analysis concerning the use beta-blocker treatment
through study completion, an average of 3 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety and depression
Time Frame: 8 weeks and 12 months after randomization
Anxiety and depression measured by Hospital Anxiety and Depression Scale (HADS)
8 weeks and 12 months after randomization
Wellbeing
Time Frame: 8 weeks and 12 months after randomization
Wellbeing measured by WHO-5 Wellbeing Index
8 weeks and 12 months after randomization
Cardiac Anxiety
Time Frame: 8 weeks and 12 months after randomization
Cardiac Anxiety measured by Cardiac Anxiety Questionnaire (CAQ)
8 weeks and 12 months after randomization
Sexual function
Time Frame: 8 weeks and 12 months after randomization
Sexual function measured by Arizona Sexual Experiences Scale (ASEX)
8 weeks and 12 months after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

Uppsala University
The Swedish Research Council

Investigators

  • Principal Investigator: Tomas Jernberg, MD PhD, Karolinska Institutet
  • Study Chair: Bertil Lindahl, MD PhD, Uppsala, Clinical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2017

Primary Completion (Actual)

November 16, 2023

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

August 31, 2017

First Submitted That Met QC Criteria

September 8, 2017

First Posted (Actual)

September 11, 2017

Study Record Updates

Last Update Posted (Actual)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EudraCT number 2017-002336-17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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