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

Acute Myocardial Infarction Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03278509
• Other study ID #: EudraCT number 2017-002336-17
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: September 11, 2017
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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..

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5000
• Est. completion date: December 31, 2025
• Est. primary completion date: November 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction
• Non-ST Elevated Myocardial Infarction
• Non-ST Elevation Myocardial Infarction
• ST Elevation Myocardial Infarction

Intervention

Drug:
• Metoprolol Succinate
Eligible patients randomized to active treatment will receive long-term oral beta-blockade (metoprolol succinate or bisoprolol).
• Bisoprolol
Please see the section above.

Locations

Country	Name	City	State
Sweden	Danderyd Hospital, Cardiac Intensive Care	Danderyd	Stockholms Län

Sponsors (3)

Lead Sponsor	Collaborator
Karolinska Institutet	The Swedish Research Council, Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anxiety and depression	Anxiety and depression measured by Hospital Anxiety and Depression Scale (HADS)	8 weeks and 12 months after randomization
Other	Wellbeing	Wellbeing measured by WHO-5 Wellbeing Index	8 weeks and 12 months after randomization
Other	Cardiac Anxiety	Cardiac Anxiety measured by Cardiac Anxiety Questionnaire (CAQ)	8 weeks and 12 months after randomization
Other	Sexual function	Sexual function measured by Arizona Sexual Experiences Scale (ASEX)	8 weeks and 12 months after randomization
Primary	Time to the composite of death of any cause or MI	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	All-cause death	Time to the individual component of the primary endpoint of any cause of death.	through study completion, an average of 3 year
Secondary	Myocardial infarction	Time to the individual component of the primary endpoint of MI.	through study completion, an average of 3 year
Secondary	Cardiovascular death	Time to cardiovascular death.	through study completion, an average of 3 year
Secondary	Heart failure	Time to hospital readmission due to heart failure (primary [main] diagnosis)	through study completion, an average of 3 year
Secondary	Atrial fibrillation	Time to hospital readmission due to atrial fibrillation (primary [main] diagnosis)	through study completion, an average of 3 year
Secondary	Bradycardia, Advanced AV-block, hypotension, syncope or need for pacemaker	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
Secondary	Asthma or Chronic Obstructive Pulmonary Disease	Time to hospital readmission due to asthma or chronic obstructive pulmonary disease (primary [main] diagnosis)	through study completion, an average of 3 year
Secondary	Stroke	Time to hospital readmission due to stroke (primary [main] diagnosis)	through study completion, an average of 3 year
Secondary	Health related quality of life (HRQOL)	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.
Secondary	Health care costs	Health care cost analysis concerning the use beta-blocker treatment	through study completion, an average of 3 year