Efficacy of Implantable Cardioverter Defibrillator in Patients With Non-ischemic Systolic Heart Failure on Mortality (DANISH)
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|ClinicalTrials.gov Identifier: NCT00541268|
Recruitment Status : Active, not recruiting
First Posted : October 10, 2007
Last Update Posted : June 20, 2016
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 etiology 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 or disease||Intervention/treatment||Phase|
|Heart Failure Dilated Cardiomyopathy Reduced LVEF||Device: ICD Other: Optimal medical treatment||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||February 2008|
|Estimated Primary Completion Date :||July 2016|
|Estimated Study Completion Date :||July 2016|
Heart Failure nonischemic etiology
Intracardioverter defibrillators from 2 different manufacturers
|Active Comparator: B||
Other: Optimal medical treatment
ACEi or angiotensin receptor blockers Betablockers Aldosterone blockers
- All cause mortality [ Time Frame: 5 years ]
- Cardiovascular death [ Time Frame: all time ]
- Sudden death [ Time Frame: all time ]
- Quality of Life [ Time Frame: all time ]Patient reported outcome thru heart failure questionnaires
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00541268
|Rigshospitalet, University of Copenhagen|
|Copenhagen, Denmark, 2100|
|Copenhagen, Denmark, 2900|
|Odense, Denmark, 5000|
|Study Chair:||Lars Køber, MD, D.Sci||Department of Cardiology, Rigshospitalet.|