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Trial record 63 of 157 for:    Idiopathic Dilated Cardiomyopathy

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
Sponsor:
Collaborator:
Danish Heart Foundation
Information provided by (Responsible Party):
Danish Study Group

Brief Summary:
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 in patients with heart failure of non-ischemic oetiology.

Condition or disease Intervention/treatment Phase
Heart Failure Dilated Cardiomyopathy Reduced LVEF Device: ICD Other: Optimal medical treatment Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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


Arm Intervention/treatment
Experimental: A
Heart Failure nonischemic ethiology
Device: ICD
Implantation of an ICD

Active Comparator: B Other: Optimal medical treatment
ACE-inhibitors or ARB Beta-blocker Optional aldosterone antagonist




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

Secondary Outcome Measures :
  1. 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
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.

Information from the National Library of Medicine

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


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Danish Study Group
ClinicalTrials.gov Identifier: NCT00542945     History of Changes
Other Study ID Numbers: Danish-ICD-001
First Posted: October 12, 2007    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Keywords provided by Danish Study Group:
Heart Failure
ICD
Dilated cardiomyopathy
Additional relevant MeSH terms:
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Heart Failure
Cardiomyopathies
Cardiomyopathy, Dilated
Heart Diseases
Cardiovascular Diseases
Cardiomegaly