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)

Jens Jakob Thune, Steen Pehrson, Jens Cosedis Nielsen, Jens Haarbo, Lars Videbæk, Eva Korup, Gunnar Jensen, Per Hildebrandt, Flemming Hald Steffensen, Niels Eske Bruun, Hans Eiskjær, Axel Brandes, Anna Margrethe Thøgersen, Kenneth Egstrup, Jesper Hastrup-Svendsen, Dan Eik Høfsten, Christian Torp-Pedersen, Lars Køber

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Resumé

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.

OriginalsprogEngelsk
TidsskriftAmerican Heart Journal
Vol/bind179
Sider (fra-til)136–141
ISSN0002-8703
DOI
StatusUdgivet - 2016

Fingeraftryk

Systolic Heart Failure
Implantable Defibrillators
Multicenter Studies
Cardiac Resynchronization Therapy
Coronary Artery Disease
Angiotensin Receptor Antagonists
Cause of Death
Guidelines

Citer dette

Thune, Jens Jakob ; Pehrson, Steen ; Nielsen, Jens Cosedis ; Haarbo, Jens ; Videbæk, Lars ; Korup, Eva ; Jensen, Gunnar ; Hildebrandt, Per ; Hald Steffensen, Flemming ; Bruun, Niels Eske ; Eiskjær, Hans ; Brandes, Axel ; Thøgersen, Anna Margrethe ; Egstrup, Kenneth ; Hastrup-Svendsen, Jesper ; Høfsten, Dan Eik ; Torp-Pedersen, Christian ; Køber, Lars. / 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). I: American Heart Journal. 2016 ; Bind 179. s. 136–141.
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title = "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)",
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.",
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author = "Thune, {Jens Jakob} and Steen Pehrson and Nielsen, {Jens Cosedis} and Jens Haarbo and Lars Videb{\ae}k and Eva Korup and Gunnar Jensen and Per Hildebrandt and {Hald Steffensen}, Flemming and Bruun, {Niels Eske} and Hans Eiskj{\ae}r and Axel Brandes and Th{\o}gersen, {Anna Margrethe} and Kenneth Egstrup and Jesper Hastrup-Svendsen and H{\o}fsten, {Dan Eik} and Christian Torp-Pedersen and Lars K{\o}ber",
note = "Copyright {\circledC} 2016 Elsevier Inc. All rights reserved.",
year = "2016",
doi = "10.1016/j.ahj.2016.06.016",
language = "English",
volume = "179",
pages = "136–141",
journal = "American Heart Journal",
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Thune, JJ, Pehrson, S, Nielsen, JC, Haarbo, J, Videbæk, L, Korup, E, Jensen, G, Hildebrandt, P, Hald Steffensen, F, Bruun, NE, Eiskjær, H, Brandes, A, Thøgersen, AM, Egstrup, K, Hastrup-Svendsen, J, Høfsten, DE, Torp-Pedersen, C & Køber, L 2016, '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)', American Heart Journal, bind 179, s. 136–141. https://doi.org/10.1016/j.ahj.2016.06.016

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). / Thune, Jens Jakob; Pehrson, Steen; Nielsen, Jens Cosedis; Haarbo, Jens; Videbæk, Lars; Korup, Eva; Jensen, Gunnar; Hildebrandt, Per; Hald Steffensen, Flemming; Bruun, Niels Eske; Eiskjær, Hans; Brandes, Axel; Thøgersen, Anna Margrethe; Egstrup, Kenneth; Hastrup-Svendsen, Jesper; Høfsten, Dan Eik; Torp-Pedersen, Christian; Køber, Lars.

I: American Heart Journal, Bind 179, 2016, s. 136–141.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

TY - JOUR

T1 - 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)

AU - Thune, Jens Jakob

AU - Pehrson, Steen

AU - Nielsen, Jens Cosedis

AU - Haarbo, Jens

AU - Videbæk, Lars

AU - Korup, Eva

AU - Jensen, Gunnar

AU - Hildebrandt, Per

AU - Hald Steffensen, Flemming

AU - Bruun, Niels Eske

AU - Eiskjær, Hans

AU - Brandes, Axel

AU - Thøgersen, Anna Margrethe

AU - Egstrup, Kenneth

AU - Hastrup-Svendsen, Jesper

AU - Høfsten, Dan Eik

AU - Torp-Pedersen, Christian

AU - Køber, Lars

N1 - Copyright © 2016 Elsevier Inc. All rights reserved.

PY - 2016

Y1 - 2016

N2 - 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.

AB - 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.

KW - Journal Article

U2 - 10.1016/j.ahj.2016.06.016

DO - 10.1016/j.ahj.2016.06.016

M3 - Journal article

VL - 179

SP - 136

EP - 141

JO - American Heart Journal

JF - American Heart Journal

SN - 0002-8703

ER -