Efficacy of Implantable Cardioverter Defibrillator in Patients With Non-ischemic Systolic Heart Failure on Mortality (DANISH)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Danish Study Group.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Danish Heart Foundation
Information provided by:
Danish Study Group
ClinicalTrials.gov Identifier:
NCT00541268
First received: October 9, 2007
Last updated: June 14, 2011
Last verified: June 2011
  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 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 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: Yes ]

Estimated Enrollment: 1000
Study Start Date: February 2008
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Heart Failure nonischemic etiology
Device: ICD
Intracardioverter defibrillators from 2 differnt manufactors
Active Comparator: B Other: Optimal medical treatment
ACEi or angiotensin receptor blockers Betablockers Aldosterone blockers

  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: NCT00541268

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
Ålborg Sygehus Recruiting
Aalborg, Denmark
Contact: Eva Korup, MD       aas.u30833@nja.dk   
Principal Investigator: Eva Korup, MD         
Rigshospitalet, University of Copenhagen Recruiting
Copenhagen, Denmark, 2100
Contact: Lars Køber, MD, D.Sci    35 45 33 76    LK@HEART.DK   
Contact: Steen Pehrson, MD, D.Sci    35 45 21 48    steen.pehrson@hr.regionh.dk   
Principal Investigator: Steen Pehrson, MD, D.Sci         
Gentofte Hospital Recruiting
Copenhagen, Denmark, 2900
Contact: Niels E Bruun, MD    39773977 ext 919    nibru@geh.regionh.dk   
Contact: Jens Haarbo, MD    39773977 ext 911    JEHAA@geh.regionh.dk   
Principal Investigator: Niels E Bruun, MD         
Odense hospital Recruiting
Odense, Denmark, 5000
Contact: Lars Videbæk, MD       Lars.Videbaek@ouh.regionsyddanmark.dk   
Contact: Axel Brandes, MD       axel.brandes@ouh.fyns-amt.dk   
Principal Investigator: Lars Videbæk, MD         
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, Rigshospitalet, University of Copenhagen
ClinicalTrials.gov Identifier: NCT00541268     History of Changes
Other Study ID Numbers: 2007-005606-45
Study First Received: October 9, 2007
Last Updated: June 14, 2011
Health Authority: Denmark: Danish Medicines Agency

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

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

ClinicalTrials.gov processed this record on August 18, 2014