Danish ICD Study in Patients With Dilated Cardiomyopathy (DANISH)
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|ClinicalTrials.gov Identifier: NCT00542945|
Recruitment Status : Completed
First Posted : October 12, 2007
Last Update Posted : July 18, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Heart Failure Dilated Cardiomyopathy Reduced LVEF||Device: ICD Other: Optimal medical treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1116 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|
|Actual Study Start Date :||March 2008|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
Heart Failure nonischemic ethiology
Implantation of an ICD
|Active Comparator: B||
Other: Optimal medical treatment
ACE-inhibitors or ARB Beta-blocker Optional aldosterone antagonist
- All cause mortality [ Time Frame: 5 years ]
- Quality of Life and health economics [ Time Frame: 5 years ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- ≥ 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).
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.
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): NCT00542945
|Rigshospitalet, University of Copenhagen|
|Copenhagen, Denmark, 2100|
|Study Chair:||Lars Køber, MD, D.Sci||Department of Cardiology, Rigshospitalet.|
|Responsible Party:||Danish Study Group|
|Other Study ID Numbers:||
|First Posted:||October 12, 2007 Key Record Dates|
|Last Update Posted:||July 18, 2019|
|Last Verified:||July 2019|
Genetic Diseases, Inborn