REDUCe
REDUCe
Project number : 254331
Created by: Karin Björling, 2018-10-23
Last revised by: Karin Björling, 2018-10-23
Project created in: Centrum för Klinisk Forskning Dalarna

PublishedPublished

Grundläggande information om projektet

Fullständig titel

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

Startdatum

2018-01-01

Beräknat slutdatum

2022-12-31

Ämnesområde

not checked Cancer
checked Cirkulation och andning
not checked Endokrinologi och metabolism
not checked Gynekologi
not checked Infektion
not checked Kirurgi
not checked Ortopedi
not checked Reumatologi
not checked Psykiatri
not checked Medicintekniska produkter
not checked Annat

Information inblandande personer och organisationer

Sammanfattning

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 944 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.

Inblandade organisationer

information Added workplaces
Landsting - Landstinget Dalarna - Hälso- och sjukvård - Specialiserad vård - Sjukhus - Falu lasarett - Kardiologiska kliniken - Övrigt (0 %)

Klinik

Kardiologkliniken, Falun

Typ av studie

not checked Klinisk prövning (Clinical Trial)
not checked Klinisk prövning, fas I (Clinical Trial Phase I)
not checked Klinisk prövning, fas II (Clinical Trial Phase II)
not checked Klinisk prövning, fas III (Clinical Trial Phase III)
checked Klinisk prövning, fas IV (Clinical Trial Phase IV)
not checked Icke interventionsstudie
not checked Kontrollerade kliniska prövningar (Controlled Clinical Trial)
checked Randomiserad klinisk prövning (Randomized Controlled Trial)
not checked Multicenter studie
not checked Akademisk studie
not checked Annat

Sponsornamn

ECR, SWEDHEART

EudraCT nummer

2017-002336-17

Status

checked Projektet pågår
not checked Projektet avslutat

REDUCe, from Centrum för Klinisk Forskning Dalarna
http://www.researchweb.org/is/en/ckfuu/project/254331