Cardiovascular Atlas
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DANISH

A randomized trial in 1116 people with symptomatic heart failure that was not caused by coronary artery disease (ejection fraction 35% or less). Half received an implantable cardioverter-defibrillator (ICD) and half received usual clinical care; in both groups 58% also received cardiac resynchronization therapy. After a median of 67.6 months, deaths from any cause were not significantly different (21.6% with an ICD, 23.4% with usual care). Sudden cardiac death was less frequent with an ICD (4.3% against 8.2%).

Also called The DANISH Study

  • Study
  • In this atlas

Overview

Design
Randomized, controlled, parallel-group study with no masking (registry). 556 patients were assigned to an ICD and 560 to usual clinical care (abstract). The registry gives primary purpose prevention.
Phase
Not applicable
Enrolled
  • 1,116 participants (enrolled count) (Danish ICD Study in Patients With Dilated Cardiomyopathy, retrieved )
Sponsor
Not recorded
Funder
  • Medtronic Named in the paper abstract as a funder, with others
Registry
  • NCT NCT00542945
Started
(actual) (Danish ICD Study in Patients With Dilated Cardiomyopathy, retrieved )
Primary completion
(actual) (Danish ICD Study in Patients With Dilated Cardiomyopathy, retrieved )
Completion
(actual) (Danish ICD Study in Patients With Dilated Cardiomyopathy, retrieved )
Countries
Denmark (Danish ICD Study in Patients With Dilated Cardiomyopathy, retrieved )
Care setting
Not reported
Registry status
  • “COMPLETED” (U.S. National Library of Medicine (ClinicalTrials.gov), retrieved )

Technical summary

ClinicalTrials.gov NCT00542945: a randomized, parallel-group study with no masking, phase not applicable, with the Danish Study Group as lead sponsor (no organization record is kept for it here) and the Danish Heart Foundation as collaborator, status completed, start 2008-03, primary completion and completion 2016-06 (all actual), enrollment 1116 (actual), one location in Denmark. The primary outcome in the registry is all-cause mortality (time frame 5 years); the paper's median follow-up was 67.6 months. The abstract names Medtronic and others as funders (see the funded_by link); the sources read do not say how that relates to the registry's sponsor. The record holds no results. The numbers are on the claim.

Arms

  • ICD

    Intervention Implantable cardioverter-defibrillator (ICD)

    Patients assigned to receive an ICD, 556 patients (abstract). The registry labels this arm A and types it experimental.

  • Usual clinical care

    Intervention None named

    Patients assigned to usual clinical care (the control group), 560 patients (abstract). The registry labels this arm B, types it active comparator and names optimal medical treatment as its intervention.

Findings

No findings are published for this study.

Record details

Record id
cardio:danish-trial
Content hash
f7bf407bfcb81847539b8ab4558e42f1f4294883689ba9a8fce9fa7aa66e80c6