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Danish ICD Study in Patients With Dilated Cardiomyopathy (DANISH)
This study is not yet open for participant recruitment.
Verified by Danish Study Group, October 2007
Sponsors and Collaborators: Danish Study Group
Danish Heart Foundation
Information provided by: Danish Study Group
ClinicalTrials.gov Identifier: NCT00542945
  Purpose

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
Heart Failure
Dilated Cardiomyopathy
Reduced LVEF
Device: ICD
Other: Optimal medical treatment
Phase IV

MedlinePlus related topics: Cardiomyopathy Heart Failure
U.S. FDA Resources
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

Further study details as provided by Danish Study Group:

Primary Outcome Measures:
  • All cause mortality [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • Quality of Life and health economics [ Time Frame: 5 years ]

Estimated Enrollment: 1000
Study Start Date: December 2007
Estimated Study Completion Date: December 2012
Arms Assigned Interventions
A: Experimental
Heart Failure nonischemic ethiology
Device: ICD
B: Active Comparator Other: Optimal medical treatment

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥ 18 years of age at the time of screening.
  • Documented non-ischemic HF with an LVEF ≤ 35%.
  • NYHA class II-III. If patients are planned for an implantation with a biventricular pacemaker NYHA class IV patients will be accepted for the trial.
  • Before any study-specific procedure, including assessments for screening, the appropriate written informed consent must be obtained (see section 12.1).
  • NT-proBNP above 200 pg/ml (see appendix D).

Exclusion Criteria:

To be eligible for this study, subjects must not meet any of the following criteria:

  • Uncorrected congenital heart disease or valve obstruction, obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, untreated hypothyroidism or hyperthyroidism, adrenal insufficiency, active vasculitis due to collagen vascular disease.
  • On the urgent waiting list for a heart transplant (UNOS category 1A or 1B, or equivalent). Patients on the non-urgent waiting list for a heart transplant (UNOS category 2 or 7, or equivalent) are eligible for inclusion in the study.
  • Recipient of any major organ transplant (eg, lung, liver, heart or kidney).
  • Receiving or has received cytotoxic or cytostatic chemotherapy and/or radiation therapy for treatment of a malignancy within 6 month before randomisation or clinical evidence of current malignancy, with the following exceptions: basal or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, prostate cancer (if stable localized disease, with a life expectancy of > 2.5 years in the opinion of the investigator).
  • Known to be human immunodeficiency virus positive with an expected survival of less than 5 years due to HIV.
  • Renal failure treated with dialysis.
  • Recent (within 3 months) history of alcohol or illicit drug abuse disorder, based on self-report
  • Any condition (eg, psychiatric illness) or situation that, in the investigator's opinion, could put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.
  • Unwilling to participate.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00542945

Contacts
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

Locations
Denmark
Rigshospitalet, University of Copenhagen
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Danish Study Group
Danish Heart Foundation
Investigators
Study Chair: Lars Køber, MD, D.Sci Department of Cardiology, Rigshospitalet.
  More Information

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

Keywords provided by Danish Study Group:
Heart Failure
ICD
Dilated cardiomyopathy

Study placed in the following topic categories:
Heart Failure
Heart Diseases
Cardiomyopathy, Dilated
Dilated cardiomyopathy
Cardiomegaly
Cardiomyopathies
Heart Failure, Systolic

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009