Danish ICD Study in Patients With Dilated Cardiomyopathy (DANISH)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Danish Heart Foundation
Information provided by (Responsible Party):
Danish Study Group
ClinicalTrials.gov Identifier:
NCT00542945
First received: October 11, 2007
Last updated: March 5, 2015
Last verified: March 2015
  Purpose

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 Intervention Phase
Heart Failure
Dilated Cardiomyopathy
Reduced LVEF
Device: ICD
Other: Optimal medical treatment
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Danish Study Group:

Primary Outcome Measures:
  • All cause mortality [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quality of Life and health economics [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: December 2007
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00542945

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

No publications provided

Responsible Party: Danish Study Group
ClinicalTrials.gov Identifier: NCT00542945     History of Changes
Other Study ID Numbers: Danish-ICD-001
Study First Received: October 11, 2007
Last Updated: March 5, 2015
Health Authority: Denmark: Danish Medicines Agency

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

Additional relevant MeSH terms:
Cardiomyopathies
Cardiomyopathy, Dilated
Heart Failure
Cardiomegaly
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on May 21, 2015