Jens Jakob Thune1, Steen Pehrson2, Jens Cosedis Nielsen3, Jens Haarbo4, Lars Videbæk5, Eva Korup6, Gunnar Jensen7, Per Hildebrandt8, Flemming Hald Steffensen9, Niels Eske Bruun10, Hans Eiskjær3, Axel Brandes5, Anna Margrethe Thøgersen6, Kenneth Egstrup11, Jesper Hastrup-Svendsen12, Dan Eik Høfsten2, Christian Torp-Pedersen6, Lars Køber2. 1. Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark; Department of Cardiology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark. Electronic address: jjt@heart.dk. 2. Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark. 3. Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark. 4. Department of Cardiology, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, Denmark. 5. Department of Cardiology, Odense University Hospital, Odense, Denmark. 6. Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark. 7. Department of Cardiology, Roskilde Hospital, Roskilde, Denmark. 8. Frederiksberg Heart Clinic, Frederiksberg, Denmark. 9. Department of Cardiology, Lillebaelt Hospital, Vejle, Denmark. 10. Department of Cardiology, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; Department of Clinical Medicine, Aalborg University, Aalborg, Denmark. 11. Department of Cardiology, Odense University Hospital, Svendborg, Denmark. 12. Department of Cardiology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.
Abstract
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. CONCLUSION: 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.
RCT Entities:
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. CONCLUSION: 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.
Authors: Johan S Bundgaard; Lauge Østergaard; Gunnar Gislason; Jens J Thune; Jens C Nielsen; Jens Haarbo; Lars Videbæk; Line L Olesen; Anna M Thøgersen; Christian Torp-Pedersen; Susanne S Pedersen; Lars Køber; Ulrik M Mogensen Journal: Qual Life Res Date: 2019-07-10 Impact factor: 4.147
Authors: Christina Byrne; Ole Ahlehoff; Marie Bayer Elming; Frants Pedersen; Steen Pehrson; Jens C Nielsen; Hans Eiskjaer; Lars Videbaek; Jesper Hastrup Svendsen; Jens Haarbo; Anna Margrethe Thøgersen; Lars Køber; Jens Jakob Thune Journal: ESC Heart Fail Date: 2022-02-02