Trial DesignRationale, 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)
Section snippets
Study design
DANISH is an investigator-initiated multicenter, randomized, unblinded, controlled, parallel, 2-group trial. Symptomatic patients (NYHA class II-III or NYHA IV if CRT was planned) with non-ischemic systolic HF (left ventricular ejection fraction [LVEF] ≤35%) and N-terminal pro-B type natriuretic peptide (NT-proBNP) >200pg/mL were randomized in a 1:1 ratio to receive an ICD or usual clinical care. Randomization was performed on a web-based system, using permuted-block randomization with block
Discussion
The DANISH study will address the use of ICD for primary prevention of all-cause mortality as well as sudden cardiac death in patients with non-ischemic systolic HF on contemporary HF therapy including CRT. In the current American guidelines, ICD treatment as primary prevention of sudden cardiac death for patients with symptomatic systolic HF has a class 1A recommendation with no differentiation between patients with ischemic and non-ischemic etiology.13 In the European guidelines, ICD
Funding
The DANISH study is investigator initiated and supported by Medtronic, St. Jude Medical, TrygFonden, and The Danish Heart Foundation.
Conflicts of interest
JCN reports speakers' fees from Biotronik and Biosense Webster and consultants' fees from Boston Scientific.
NEB reports speakers' fees from Biotronik.
AB reports consulting fees/honoraria from Bayer, BoehringerIngelheim, Pfizer.
JHS reports research grants and personal fees from Medtronic and research grants and personal fees from Biotronik in relation to the submitted work. In addition, research grant from Gilead and personal fees from Boehringer Ingelheim outside the submitted work.
CTP has
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Cited by (29)
Right Ventricular Free Wall Strain and Effect of Defibrillator Implantation in Patients With Nonischemic Systolic Heart Failure
2023, Journal of Cardiac FailureAtrial fibrillation is a marker of increased mortality risk in nonischemic heart failure—Results from the DANISH trial
2021, American Heart JournalCitation Excerpt :The data underlying this article will be shared on reasonable request to the corresponding author. The criteria for enrolment in this study have been described elsewhere15; in brief patients had nonischemic HF with a left ventricular ejection fraction (LVEF) ≤35%, elevated N-terminal pro-brain natriuretic peptides (NT-proBNP) >200 pg/mL and were on maximal tolerable, stable standard HF medication (Angiotensin converting enzyme inhibitors [ACE-I]/Angiotensin II receptor blocker [ARB], beta blockers and if possible a mineralocorticoid receptor antagonist [MRA]). For this study, we used the 7-lead Rozinn RZ153+ Holter recorder (ScottCare).
Self-reported health status and the associated risk of mortality in heart failure: The DANISH trial
2020, Journal of Psychosomatic ResearchCitation Excerpt :In this study, we examined whether good health status can be regarded as more favorable than having a fair health status (mode) in patients with HF from the DANISH (Defibrillator Implantation in Patients with Nonischemic Systolic HF) trial [20]. Study design and subsequent results of the DANISH trial (ClinicalTrials.gov number, NCT00542945) have been reported previously [21–23]. In brief, the DANISH trial was a randomized national multicenter study that investigated the efficacy of primary prophylactic implantable cardioverter defibrillator (ICD) implantation in patients with symptomatic non-ischemic systolic HF.
Quality of life and the associated risk of all-cause mortality in nonischemic heart failure
2020, International Journal of CardiologyCitation Excerpt :The DANISH trial was performed in accordance with the Declaration of Helsinki. HRQoL was measured by the disease-specific survey Minnesota Living with Heart Failure Questionnaire (MLHFQ), which assesses the perceived impact of HF [17]. The MLHFQ was self-assessed at hospital prior to randomization.
Myocardial fibrosis and the effect of primary prophylactic defibrillator implantation in patients with non-ischemic systolic heart failure—DANISH-MRI
2020, American Heart JournalCitation Excerpt :This pre-specified single-center CMR study was conducted between February 2008 and June 2014 as a sub-study to the DANISH study at Rigshospitalet.5 Detailed design of the DANISH trial has previously been reported.18 In brief, the DANISH trial was a randomized multi-center clinical trial, investigating the effect of ICD implantation in patients with non-ischemic systolic heart failure.5
Risk Models for Prediction of Implantable Cardioverter-Defibrillator Benefit: Insights From the DANISH Trial
2019, JACC: Heart FailureCitation Excerpt :DANISH was a randomized trial studying the effect of ICD implantation in patients with nonischemic HF on mortality. The design and main findings of DANISH are published (10,14). Briefly, patients were eligible if they had a nonischemic cause of HF, were in New York Heart Association (NYHA) functional class II to III or NYHA functional class IV if cardiac resynchronization therapy (CRT) was planned, had a documented left ventricular ejection fraction (LVEF) ≤35% and N-terminal pro-B-type natriuretic peptide (NT-proBNP) level >200 pg/ml (23.6 pmol/l).
ClinicalTrials.gov identifier: NCT00542945.