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Sponsors and Collaborators: |
Danish Study Group Danish Heart Foundation |
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Information provided by: | Danish Study Group |
ClinicalTrials.gov Identifier: | NCT00542945 |
Primary objective: The primary objective of this study is to determine the efficacy of ICD therapy compared with control on the endpoint of death from any cause.
Secondary objective: The secondary objectives of the study are to determine if ICD therapy reduces sudden death.
Study design: Randomized, unblinded, controlled, parallel two group trial.
Primary endpoint: Time to death from any cause.
Sample size: In total, 1000 patients with 500 receiving ICD and 500 patients constituting the control group.
Summary of Subject Eligibility Criteria: Patients with clinical heart failure, left ventricular ejection fraction (LVEF) ≤ 35%, non-ischemic ethiology and NT-proBNP above 200 pg/ml. Patients in NYHA class IV will only be randomised if also fulfilling criteria for a biventricular pacemaker.
Control group: Patients receiving standard therapy for heart failure including ACE-inhibitor/Angiotensin-Receptor-Blocker and Betablocker unless not tolerated. Aldosterone antagonism is optional.
Study Duration: The study comprises a screening period of up to 2 years, followed by a treatment phase of a minimum of 36 months.
Randomisation: After fulfilling all eligibility criteria, subjects will be randomized 1:1 to receive ICD implantation or continue usual control. Randomisation will be stratified according to treatment with a biventricular pacemaker.
Treatment: After randomisation patients allocated to ICD treatment should receive this as fast as possible and preferably within 2 weeks (latest 4 weeks). The ICD will be programmed with anti-tachycardia pacing and shock therapy.
Assessments: Deaths and hospitalisations for heart failure, stroke or arrhythmias will be recorded throughout the study duration.
Statistical Considerations: Median lifetime in the control group is expected to be 5 years. A p-value of 5% (2-sided) is required for significance together with a power of at least 80%. With a relative risk reduction of 25% a sample size of 812 patients in total is required. In order to allow for cross-over a sample size of 1000 is planned.
Primary Endpoint Analysis: The principal analysis for the primary endpoint (time to death from any cause) will employ the intent-to-treat principle and use a survival analysis.
Secondary Endpoint Analysis: All time-to-event secondary endpoints will be analyzed similarly to the primary endpoint.
Condition | Intervention | Phase |
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Heart Failure Dilated Cardiomyopathy Reduced LVEF |
Device: ICD Other: Optimal medical treatment |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A DANish Randomized, Controlled, Multicenter Study to Assess the Efficacy of Implantable Cardioverter Defibrillator in Patients With Non-Ischemic Systolic Heart Failure on Mortality. The DANISH Study |
Estimated Enrollment: | 1000 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | December 2012 |
Arms | Assigned Interventions |
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A: Experimental
Heart Failure nonischemic ethiology
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Device: ICD |
B: Active Comparator | Other: Optimal medical treatment |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
To be eligible for this study, subjects must not meet any of the following criteria:
Contact: Lars Kober, MD, DSci | 35 45 33 76 | LK@HEART.DK |
Contact: Steen Pehrson, MD, D.Sci | 35 45 21 84 | steen.pehrson@rh.regionh.dk |
Denmark | |
Rigshospitalet, University of Copenhagen | |
Copenhagen, Denmark, 2100 |
Study Chair: | Lars Køber, MD, D.Sci | Department of Cardiology, Rigshospitalet. |
Study ID Numbers: | Danish-ICD-001 |
Study First Received: | October 11, 2007 |
Last Updated: | October 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00542945 |
Health Authority: | Denmark: Danish Medicines Agency |
Heart Failure ICD Dilated cardiomyopathy |
Heart Failure Heart Diseases Cardiomyopathy, Dilated Dilated cardiomyopathy |
Cardiomegaly Cardiomyopathies Heart Failure, Systolic |
Cardiovascular Diseases |