NCT00542945

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,116

participants targeted

Target at P75+ for not_applicable heart-failure

Timeline
Completed

Started Mar 2008

Longer than P75 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 12, 2007

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

July 18, 2019

Status Verified

July 1, 2019

Enrollment Period

8.3 years

First QC Date

October 11, 2007

Last Update Submit

July 16, 2019

Conditions

Heart FailureDilated CardiomyopathyReduced LVEF

Keywords

Heart FailureICDDilated cardiomyopathy

Outcome Measures

Primary Outcomes (1)

  • All cause mortality

    5 years

Secondary Outcomes (1)

  • Quality of Life and health economics

    5 years

Study Arms (2)

A

EXPERIMENTAL

Heart Failure nonischemic ethiology

Device: ICD

B

ACTIVE COMPARATOR
Other: Optimal medical treatment

Interventions

ICDDEVICE

Implantation of an ICD

A
Optimal medical treatmentOTHER

ACE-inhibitors or ARB Beta-blocker Optional aldosterone antagonist

B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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).

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet, University of Copenhagen

Copenhagen, 2100, Denmark

Location

Related Publications (16)

  • Butt JH, Doi SN, Thune JJ, Nielsen JC, Videbaek L, Yafasova A, Bruun NE, Torp-Pedersen C, Eiskjaer H, Egstrup K, Brandes A, Hassager C, Svendsen JH, Hofsten D, Pehrson S, Kober L. Long-Term Effect of ICDs in Nonischemic Heart Failure With Reduced Ejection Fraction: Extended Follow-Up Analysis of DANISH. J Am Coll Cardiol. 2025 Dec 16;86(24):2402-2414. doi: 10.1016/j.jacc.2025.08.089. Epub 2025 Oct 22.

    PMID: 41123523DERIVED

  • Butt JH, Bundgaard JS, Schou M, Yafasova A, Doi SN, Svendsen JH, Hofsten DE, Hassager C, Eiskjaer H, Nielsen JC, Bruun NE, Videbaek L, Brandes A, Thune JJ, Pehrson S, Kober L. Implantable Cardioverter-Defibrillator and Frailty in Non-ischemic Heart Failure With Reduced Ejection Fraction: Extended Follow-Up of the DANISH Trial. Am J Cardiol. 2026 Jan 15;259:163-172. doi: 10.1016/j.amjcard.2025.08.068. Epub 2025 Sep 23.

    PMID: 40998196DERIVED

  • Doi SN, Yafasova A, Thune JJ, Nielsen JC, Bruun NE, Videbaek L, Eiskjaer H, Hassager C, Svendsen JH, Hofsten DE, Pehrson S, Kober L, Butt JH. Atrial fibrillation and implantable cardioverter-defibrillator in non-ischaemic heart failure with reduced ejection fraction: insights from the DANISH trial. Europace. 2025 Sep 1;27(9):euaf200. doi: 10.1093/europace/euaf200.

    PMID: 40990042DERIVED

  • Butt JH, Thune JJ, Nielsen JC, Haarbo J, Videbaek L, Gustafsson F, Kristensen SL, Bruun NE, Eiskjaer H, Brandes A, Hassager C, Svendsen JH, Hofsten DE, Torp-Pedersen C, Schou M, Pehrson S, Packer M, McMurray JJV, Kober L. Anthropometric measures and long-term mortality in non-ischaemic heart failure with reduced ejection fraction: Questioning the obesity paradox. Eur J Heart Fail. 2025 Mar;27(3):527-536. doi: 10.1002/ejhf.3424. Epub 2024 Aug 18.

    PMID: 39155576DERIVED

  • Karacan MN, Doi SN, Yafasova A, Thune JJ, Nielsen JC, Haarbo J, Bruun NE, Gustafsson F, Eiskjaer H, Hassager C, Svendsen JH, Hofsten DE, Pehrson S, Kober L, Butt JH. New York Heart Association functional class and implantable cardioverter-defibrillator in non-ischaemic heart failure with reduced ejection fraction: Extended follow-up of the DANISH trial. Eur J Heart Fail. 2024 Jun;26(6):1423-1431. doi: 10.1002/ejhf.3239. Epub 2024 May 11.

    PMID: 38733253DERIVED

  • Doi SN, Thune JJ, Nielsen JC, Haarbo J, Videbaek L, Yafasova A, Bruun NE, Gustafsson F, Eiskjaer H, Hassager C, Svendsen JH, Hofsten DE, Torp-Pedersen C, Pehrson S, Kober L, Butt JH. Estimated Glomerular Filtration Rate and Implantable Cardioverter-Defibrillator in Nonischemic Systolic Heart Failure: Extended Follow-Up of DANISH. J Am Heart Assoc. 2024 Feb 6;13(3):e031977. doi: 10.1161/JAHA.123.031977. Epub 2024 Jan 31.

    PMID: 38293926DERIVED

  • Butt JH, Yafasova A, Doi SN, Nielsen JC, Haarbo J, Eiskjaer H, Brandes A, Thogersen AM, Gustafsson F, Hassager C, Svendsen JH, Hofsten DE, Videbaek L, Torp-Pedersen C, Pehrson S, Thune JJ, Kober L. Implantable Cardioverter Defibrillator in Patients With Nonischemic Systolic Heart Failure With and Without Cardiac Resynchronization Therapy: Extended Follow-Up Study of the DANISH Trial. Circulation. 2023 Oct 10;148(15):1179-1181. doi: 10.1161/CIRCULATIONAHA.123.065560. Epub 2023 Oct 9. No abstract available.

    PMID: 37812653DERIVED

  • Butt JH, Yafasova A, Elming MB, Dixen U, Nielsen JC, Haarbo J, Videbaek L, Korup E, Bruun NE, Eiskjaer H, Brandes A, Thogersen AM, Gustafsson F, Egstrup K, Hassager C, Svendsen JH, Hofsten DE, Torp-Pedersen C, Pehrson S, Thune JJ, Kober L. Efficacy of Implantable Cardioverter Defibrillator in Nonischemic Systolic Heart Failure According to Sex: Extended Follow-Up Study of the DANISH Trial. Circ Heart Fail. 2022 Sep;15(9):e009669. doi: 10.1161/CIRCHEARTFAILURE.122.009669. Epub 2022 Aug 9.

    PMID: 35942877DERIVED

  • Butt JH, Yafasova A, Elming MB, Dixen U, Nielsen JC, Haarbo J, Videbaek L, Korup E, Bruun NE, Eiskjaer H, Brandes A, Thogersen AM, Gustafsson F, Egstrup K, Hassager C, Svendsen JH, Hofsten DE, Torp-Pedersen C, Pehrson S, Thune JJ, Kober L. NT-proBNP and ICD in Nonischemic Systolic Heart Failure: Extended Follow-Up of the DANISH Trial. JACC Heart Fail. 2022 Mar;10(3):161-171. doi: 10.1016/j.jchf.2022.01.003.

    PMID: 35241243DERIVED

  • Yafasova A, Butt JH, Elming MB, Nielsen JC, Haarbo J, Videbaek L, Olesen LL, Steffensen FH, Bruun NE, Eiskjaer H, Brandes A, Thogersen AM, Egstrup K, Gustafsson F, Hassager C, Svendsen JH, Hofsten DE, Torp-Pedersen C, Pehrson S, Thune JJ, Kober L. Long-Term Follow-Up of DANISH (The Danish Study to Assess the Efficacy of ICDs in Patients With Nonischemic Systolic Heart Failure on Mortality). Circulation. 2022 Feb 8;145(6):427-436. doi: 10.1161/CIRCULATIONAHA.121.056072. Epub 2021 Dec 9.

    PMID: 34882430DERIVED

  • Bundgaard JS, Thune JJ, Gislason G, Fosbol EL, Torp-Pedersen C, Aagaard D, Nielsen JC, Haarbo J, Thogersen AM, Videbaek L, Jensen G, Olesen LL, Kristensen SL, Pedersen SS, Kober L, Mogensen UM. Quality of life and the associated risk of all-cause mortality in nonischemic heart failure. Int J Cardiol. 2020 Apr 15;305:92-98. doi: 10.1016/j.ijcard.2020.02.008. Epub 2020 Feb 4.

    PMID: 32046910DERIVED

  • Elming MB, Thogersen AM, Videbaek L, Bruun NE, Eiskjaer H, Haarbo J, Egstrup K, Gustafsson F, Hastrup Svendsen J, Hofsten DE, Pehrson S, Nielsen JC, Kober L, Thune JJ. Duration of Heart Failure and Effect of Defibrillator Implantation in Patients With Nonischemic Systolic Heart Failure. Circ Heart Fail. 2019 Sep;12(9):e006022. doi: 10.1161/CIRCHEARTFAILURE.119.006022. Epub 2019 Sep 10.

    PMID: 31500444DERIVED

  • Kristensen SL, Levy WC, Shadman R, Nielsen JC, Haarbo J, Videbaek L, Bruun NE, Eiskjaer H, Wiggers H, Brandes A, Thogersen AM, Hassager C, Svendsen JH, Hofsten DE, Torp-Pedersen C, Pehrson S, Signorovitch J, Kober L, Thune JJ. Risk Models for Prediction of Implantable Cardioverter-Defibrillator Benefit: Insights From the DANISH Trial. JACC Heart Fail. 2019 Aug;7(8):717-724. doi: 10.1016/j.jchf.2019.03.019. Epub 2019 Jul 10.

    PMID: 31302052DERIVED

  • Elming MB, Hammer-Hansen S, Voges I, Nyktari E, Raja AA, Svendsen JH, Pehrson S, Signorovitch J, Kober LV, Prasad SK, Thune JJ. Right Ventricular Dysfunction and the Effect of Defibrillator Implantation in Patients With Nonischemic Systolic Heart Failure. Circ Arrhythm Electrophysiol. 2019 Mar;12(3):e007022. doi: 10.1161/CIRCEP.118.007022.

    PMID: 30866666DERIVED

  • Elming MB, Nielsen JC, Haarbo J, Videbaek L, Korup E, Signorovitch J, Olesen LL, Hildebrandt P, Steffensen FH, Bruun NE, Eiskjaer H, Brandes A, Thogersen AM, Gustafsson F, Egstrup K, Videbaek R, Hassager C, Svendsen JH, Hofsten DE, Torp-Pedersen C, Pehrson S, Kober L, Thune JJ. Age and Outcomes of Primary Prevention Implantable Cardioverter-Defibrillators in Patients With Nonischemic Systolic Heart Failure. Circulation. 2017 Nov 7;136(19):1772-1780. doi: 10.1161/CIRCULATIONAHA.117.028829. Epub 2017 Sep 6.

    PMID: 28877914DERIVED

  • Kober L, Thune JJ, Nielsen JC, Haarbo J, Videbaek L, Korup E, Jensen G, Hildebrandt P, Steffensen FH, Bruun NE, Eiskjaer H, Brandes A, Thogersen AM, Gustafsson F, Egstrup K, Videbaek R, Hassager C, Svendsen JH, Hofsten DE, Torp-Pedersen C, Pehrson S; DANISH Investigators. Defibrillator Implantation in Patients with Nonischemic Systolic Heart Failure. N Engl J Med. 2016 Sep 29;375(13):1221-30. doi: 10.1056/NEJMoa1608029. Epub 2016 Aug 27.

    PMID: 27571011DERIVED

MeSH Terms

Conditions

Heart FailureCardiomyopathy, Dilated

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesCardiomegalyCardiomyopathiesLaminopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Lars Køber, MD, D.Sci

    Department of Cardiology, Rigshospitalet.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2007

First Posted

October 12, 2007

Study Start

March 1, 2008

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

July 18, 2019

Record last verified: 2019-07

Locations

DK(1)