Rationale, design, and baseline characteristics of the DANish randomized, controlled, multicenter study to assess the efficacy of Implantable cardioverter defibrillators in patients with non-ischemic Systolic Heart failure on mortality (DANISH).
BACKGROUND
The effect of an implantable cardioverter defibrillator (ICD) in patients with symptomatic systolic heart failure (HF) caused by coronary artery disease is well documented. However, the effect of primary prophylactic ICDs in patients with systolic HF not due to coronary artery disease is much weaker. In addition, HF management has improved, since the landmark ICD trials and a large proportion of patients now receive cardiac resynchronization therapy (CRT) where the effect of ICD treatment is unknown.


METHODS
In the DANISH study, 1,116 patients with symptomatic systolic HF not caused by coronary artery disease have been randomized to receive an ICD or not, in addition to contemporary standard therapy. The primary outcome of the trial is time to all-cause death. Follow-up will continue until June 2016 with a median follow-up period of 5 years. Baseline characteristics show that enrolled patients are treated according to current guidelines. At baseline, 97% of patients received an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker, 92% received a β-blocker, 58% a mineralocorticoid receptor antagonist, and 58% were scheduled to receive CRT. Median age was 63 years (range, 21-84 years) at baseline, and 28% were women.


CONCLUSIONS
DANISH will provide pertinent information about the effect on all-cause mortality of a primary prophylactic ICD in patients with symptomatic systolic HF not caused by coronary artery disease on contemporary standard therapy including CRT.
Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark; Department of Cardiology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark. Electronic address: jjt@heart.dk.
Jens Jakob
JJ
Thune
Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
Steen
S
Pehrson
Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.
Jens Cosedis
JC
Nielsen
Department of Cardiology, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.
Jens
J
Haarbo
Department of Cardiology, Odense University Hospital, Odense, Denmark.
Lars
L
Videbæk
Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.
Eva
E
Korup
Department of Cardiology, Roskilde Hospital, Roskilde, Denmark.
Gunnar
G
Jensen
Frederiksberg Heart Clinic, Frederiksberg, Denmark.
Per
P
Hildebrandt
Department of Cardiology, Lillebaelt Hospital, Vejle, Denmark.
Flemming Hald
FH
Steffensen
Department of Cardiology, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.
Niels Eske
NE
Bruun
Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.
Hans
H
Eiskjær
Department of Cardiology, Odense University Hospital, Odense, Denmark.
Axel
A
Brandes
Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.
Anna Margrethe
AM
Thøgersen
Department of Cardiology, Odense University Hospital, Svendborg, Denmark.
Kenneth
K
Egstrup
Department of Cardiology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.
Jesper
J
Hastrup-Svendsen
Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
Dan Eik
DE
Høfsten
Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.
Christian
C
Torp-Pedersen
Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
Lars
L
Køber
D000319:Adrenergic beta-Antagonists / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000627:therapeutic use*; D058406:Cardiac Resynchronization Therapy; D016757:Death, Sudden, Cardiac / Q000209:etiology / Q000517:prevention & control*; D017147:Defibrillators, Implantable; D005260:Female; D054143:Heart Failure, Systolic / Q000150:complications / Q000628:therapy*; D006349:Heart Valve Diseases / Q000150:complications; D006801:Humans; D006973:Hypertension / Q000150:complications; D008297:Male; D008875:Middle Aged; D000451:Mineralocorticoid Receptor Antagonists / Q000627:therapeutic use*; D009026:Mortality; D055815:Young Adult
D000319:Adrenergic beta-Antagonists; D000806:Angiotensin-Converting Enzyme Inhibitors; D000451:Mineralocorticoid Receptor Antagonists