Efficacy and safety of low‐dose digoxin in patients with heart failure. Rationale and design of the DECISION trial
Aims Digoxin is the oldest drug in cardiovascular (CV) medicine, and one trial conducted >25 years ago showed a reduction in heart failure (HF) hospitalizations but no effect on mortality. However, later studies suggested that the dose of digoxin used in that trial (and other studies) may have be...
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| Veröffentlicht in: | European journal of heart failure 2024-10, Vol.26 (10), p.2223-2230 |
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| creator | Veldhuisen, Dirk J. Rienstra, Michiel Mosterd, Arend Alings, A. Marco Asselt, Antoinette D.J. Bouvy, Marcel L Tijssen, Jan G.P. Schaap, Jeroen Wall, Ernst E. Voors, Adriaan A. Boorsma, Eva M. Lok, Dirk J.A. Crijns, Harry J.G.M. Schut, Astrid Vijver, Marlene A.T. Voordes, Geert H.D. Vos, Agaath H. Maas‐Soer, Ester L. Smit, Nicoline W. Touw, Daan J. Samuel, Michelle Meer, Peter Veldhuisen, Dirk J. Meer, Peter Rienstra, Michiel Mosterd, Arend Alings, Marco Tijssen, Jan Asselt, Thea Bouvy, Marcel Wall, Ernst E. Schaap, Jeroen Voors, Adriaan A. Crijns, Harry J. G. M. Gaillard, Carlo Veeger, Nick |
| description | Aims
Digoxin is the oldest drug in cardiovascular (CV) medicine, and one trial conducted >25 years ago showed a reduction in heart failure (HF) hospitalizations but no effect on mortality. However, later studies suggested that the dose of digoxin used in that trial (and other studies) may have been too high. The DECISION (Digoxin Evaluation in Chronic heart failure: Investigational Study In Outpatients in the Netherlands) trial will examine the efficacy and safety of low‐dose digoxin in HF patients with reduced or mildly reduced left ventricular ejection fraction (LVEF) with a background of contemporary HF treatment.
Methods
The DECISION trial is a randomized, double‐blind, parallel‐group, placebo‐controlled event‐driven outcome trial which will investigate the efficacy and safety of low‐dose digoxin in patients with chronic HF and LVEF |
| doi_str_mv | 10.1002/ejhf.3428 |
| format | Article |
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Digoxin is the oldest drug in cardiovascular (CV) medicine, and one trial conducted >25 years ago showed a reduction in heart failure (HF) hospitalizations but no effect on mortality. However, later studies suggested that the dose of digoxin used in that trial (and other studies) may have been too high. The DECISION (Digoxin Evaluation in Chronic heart failure: Investigational Study In Outpatients in the Netherlands) trial will examine the efficacy and safety of low‐dose digoxin in HF patients with reduced or mildly reduced left ventricular ejection fraction (LVEF) with a background of contemporary HF treatment.
Methods
The DECISION trial is a randomized, double‐blind, parallel‐group, placebo‐controlled event‐driven outcome trial which will investigate the efficacy and safety of low‐dose digoxin in patients with chronic HF and LVEF <50%. Both patients with sinus rhythm and atrial fibrillation will be enrolled and will be randomized (1:1) to low‐dose digoxin or matching placebo. To maintain a target serum digoxin concentration of 0.5–0.9 ng/ml, dose adjustments are made throughout follow‐up based on serum digoxin measurements with dummy values for the placebo group. The primary endpoint is a composite of CV mortality and total HF hospitalizations or total urgent hospital visits for worsening HF, and all endpoints are adjudicated blindly by a Clinical Event Committee. The estimated sample size was 982 patients who will be followed for a median of 3 years, and in December 2023 enrolment was completed after 1002 patients.
Conclusions
The DECISION trial will provide important evidence regarding the effect of (low‐dose) digoxin on CV mortality and total HF hospitalizations and urgent hospital visits when added to contemporary HF treatment of patients with reduced or mildly reduced LVEF.
Clinical Trial Registration: ClinicalTrials.gov identifier: NCT03783429.
Rationale and design of the DECISION trial. ECG, electrocardiogram; HF, heart failure; LVEF, left ventricular ejection fraction; NT‐proBNP, N‐terminal pro‐B‐type natriuretic peptide; NYHA, New York Heart Association.</description><identifier>ISSN: 1388-9842</identifier><identifier>ISSN: 1879-0844</identifier><identifier>EISSN: 1879-0844</identifier><identifier>DOI: 10.1002/ejhf.3428</identifier><identifier>PMID: 39212246</identifier><language>eng</language><publisher>Oxford, UK: John Wiley & Sons, Ltd</publisher><subject>Aged ; Cardiotonic Agents - administration & dosage ; Cardiotonic Agents - therapeutic use ; Digoxin ; Digoxin - administration & dosage ; Digoxin - adverse effects ; Digoxin - therapeutic use ; Dose-Response Relationship, Drug ; Double-Blind Method ; Female ; Heart failure ; Heart Failure - drug therapy ; Heart Failure - mortality ; Heart Failure - physiopathology ; Hospitalization - statistics & numerical data ; Hospitalizations ; Humans ; Low‐dose ; Male ; Middle Aged ; Mortality ; Netherlands - epidemiology ; Randomized clinical trial ; Stroke Volume - physiology ; Treatment Outcome ; Ventricular Function, Left - drug effects ; Ventricular Function, Left - physiology</subject><ispartof>European journal of heart failure, 2024-10, Vol.26 (10), p.2223-2230</ispartof><rights>2024 The Author(s). published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.</rights><rights>2024 The Author(s). European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c2508-3af96245a54c991ce94684c88cea2d2c8c164402bec5f56502a4a271273888c3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fejhf.3428$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fejhf.3428$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/39212246$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Veldhuisen, Dirk J.</creatorcontrib><creatorcontrib>Rienstra, Michiel</creatorcontrib><creatorcontrib>Mosterd, Arend</creatorcontrib><creatorcontrib>Alings, A. Marco</creatorcontrib><creatorcontrib>Asselt, Antoinette D.J.</creatorcontrib><creatorcontrib>Bouvy, Marcel L</creatorcontrib><creatorcontrib>Tijssen, Jan G.P.</creatorcontrib><creatorcontrib>Schaap, Jeroen</creatorcontrib><creatorcontrib>Wall, Ernst E.</creatorcontrib><creatorcontrib>Voors, Adriaan A.</creatorcontrib><creatorcontrib>Boorsma, Eva M.</creatorcontrib><creatorcontrib>Lok, Dirk J.A.</creatorcontrib><creatorcontrib>Crijns, Harry J.G.M.</creatorcontrib><creatorcontrib>Schut, Astrid</creatorcontrib><creatorcontrib>Vijver, Marlene A.T.</creatorcontrib><creatorcontrib>Voordes, Geert H.D.</creatorcontrib><creatorcontrib>Vos, Agaath H.</creatorcontrib><creatorcontrib>Maas‐Soer, Ester L.</creatorcontrib><creatorcontrib>Smit, Nicoline W.</creatorcontrib><creatorcontrib>Touw, Daan J.</creatorcontrib><creatorcontrib>Samuel, Michelle</creatorcontrib><creatorcontrib>Meer, Peter</creatorcontrib><creatorcontrib>Veldhuisen, Dirk J.</creatorcontrib><creatorcontrib>Meer, Peter</creatorcontrib><creatorcontrib>Rienstra, Michiel</creatorcontrib><creatorcontrib>Mosterd, Arend</creatorcontrib><creatorcontrib>Alings, Marco</creatorcontrib><creatorcontrib>Tijssen, Jan</creatorcontrib><creatorcontrib>Asselt, Thea</creatorcontrib><creatorcontrib>Bouvy, Marcel</creatorcontrib><creatorcontrib>Wall, Ernst E.</creatorcontrib><creatorcontrib>Schaap, Jeroen</creatorcontrib><creatorcontrib>Voors, Adriaan A.</creatorcontrib><creatorcontrib>Crijns, Harry J. G. M.</creatorcontrib><creatorcontrib>Gaillard, Carlo</creatorcontrib><creatorcontrib>Veeger, Nick</creatorcontrib><creatorcontrib>DECISION Investigators and Committees</creatorcontrib><title>Efficacy and safety of low‐dose digoxin in patients with heart failure. Rationale and design of the DECISION trial</title><title>European journal of heart failure</title><addtitle>Eur J Heart Fail</addtitle><description>Aims
Digoxin is the oldest drug in cardiovascular (CV) medicine, and one trial conducted >25 years ago showed a reduction in heart failure (HF) hospitalizations but no effect on mortality. However, later studies suggested that the dose of digoxin used in that trial (and other studies) may have been too high. The DECISION (Digoxin Evaluation in Chronic heart failure: Investigational Study In Outpatients in the Netherlands) trial will examine the efficacy and safety of low‐dose digoxin in HF patients with reduced or mildly reduced left ventricular ejection fraction (LVEF) with a background of contemporary HF treatment.
Methods
The DECISION trial is a randomized, double‐blind, parallel‐group, placebo‐controlled event‐driven outcome trial which will investigate the efficacy and safety of low‐dose digoxin in patients with chronic HF and LVEF <50%. Both patients with sinus rhythm and atrial fibrillation will be enrolled and will be randomized (1:1) to low‐dose digoxin or matching placebo. To maintain a target serum digoxin concentration of 0.5–0.9 ng/ml, dose adjustments are made throughout follow‐up based on serum digoxin measurements with dummy values for the placebo group. The primary endpoint is a composite of CV mortality and total HF hospitalizations or total urgent hospital visits for worsening HF, and all endpoints are adjudicated blindly by a Clinical Event Committee. The estimated sample size was 982 patients who will be followed for a median of 3 years, and in December 2023 enrolment was completed after 1002 patients.
Conclusions
The DECISION trial will provide important evidence regarding the effect of (low‐dose) digoxin on CV mortality and total HF hospitalizations and urgent hospital visits when added to contemporary HF treatment of patients with reduced or mildly reduced LVEF.
Clinical Trial Registration: ClinicalTrials.gov identifier: NCT03783429.
Rationale and design of the DECISION trial. ECG, electrocardiogram; HF, heart failure; LVEF, left ventricular ejection fraction; NT‐proBNP, N‐terminal pro‐B‐type natriuretic peptide; NYHA, New York Heart Association.</description><subject>Aged</subject><subject>Cardiotonic Agents - administration & dosage</subject><subject>Cardiotonic Agents - therapeutic use</subject><subject>Digoxin</subject><subject>Digoxin - administration & dosage</subject><subject>Digoxin - adverse effects</subject><subject>Digoxin - therapeutic use</subject><subject>Dose-Response Relationship, Drug</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Heart failure</subject><subject>Heart Failure - drug therapy</subject><subject>Heart Failure - mortality</subject><subject>Heart Failure - physiopathology</subject><subject>Hospitalization - statistics & numerical data</subject><subject>Hospitalizations</subject><subject>Humans</subject><subject>Low‐dose</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Mortality</subject><subject>Netherlands - epidemiology</subject><subject>Randomized clinical trial</subject><subject>Stroke Volume - physiology</subject><subject>Treatment Outcome</subject><subject>Ventricular Function, Left - drug effects</subject><subject>Ventricular Function, Left - physiology</subject><issn>1388-9842</issn><issn>1879-0844</issn><issn>1879-0844</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>EIF</sourceid><recordid>eNp1kNFOwjAUQBujEUQf_AHTR30Ytl032keDIBgiifK-lO6WlYwN1xLkzU_wG_0SN0DfTJrcJvfkJPcgdE1JlxLC7mGZmW7ImThBbSp6MiCC89P6HwoRSMFZC104tySE9mr8HLVCyShjPG4jPzDGaqV3WBUpdsqA3-HS4Lzcfn9-paUDnNpF-WELXL-18hYK7_DW-gxnoCqPjbL5poIufq2XZaFy2KtScHZRNCqfAX4c9Mdv4-kL9pVV-SU6Myp3cHWcHTQbDmb9UTCZPo37D5NAs4iIIFRGxoxHKuJaSqpB8lhwLYQGxVKmhaYx54TNQUcmiiPCFFesR1mvvlvosINuD9p1Vb5vwPlkZZ2GPFcFlBuXhERKQaIwlDV6d0B1VTpXgUnWlV2papdQkjSNk6Zx0jSu2ZujdjNfQfpH_katgfsDsLU57P43JYPn0XCv_AGbjoZT</recordid><startdate>202410</startdate><enddate>202410</enddate><creator>Veldhuisen, Dirk J.</creator><creator>Rienstra, Michiel</creator><creator>Mosterd, Arend</creator><creator>Alings, A. Marco</creator><creator>Asselt, Antoinette D.J.</creator><creator>Bouvy, Marcel L</creator><creator>Tijssen, Jan G.P.</creator><creator>Schaap, Jeroen</creator><creator>Wall, Ernst E.</creator><creator>Voors, Adriaan A.</creator><creator>Boorsma, Eva M.</creator><creator>Lok, Dirk J.A.</creator><creator>Crijns, Harry J.G.M.</creator><creator>Schut, Astrid</creator><creator>Vijver, Marlene A.T.</creator><creator>Voordes, Geert H.D.</creator><creator>Vos, Agaath H.</creator><creator>Maas‐Soer, Ester L.</creator><creator>Smit, Nicoline W.</creator><creator>Touw, Daan J.</creator><creator>Samuel, Michelle</creator><creator>Meer, Peter</creator><creator>Veldhuisen, Dirk J.</creator><creator>Meer, Peter</creator><creator>Rienstra, Michiel</creator><creator>Mosterd, Arend</creator><creator>Alings, Marco</creator><creator>Tijssen, Jan</creator><creator>Asselt, Thea</creator><creator>Bouvy, Marcel</creator><creator>Wall, Ernst E.</creator><creator>Schaap, Jeroen</creator><creator>Voors, Adriaan A.</creator><creator>Crijns, Harry J. G. M.</creator><creator>Gaillard, Carlo</creator><creator>Veeger, Nick</creator><general>John Wiley & Sons, Ltd</general><scope>24P</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>202410</creationdate><title>Efficacy and safety of low‐dose digoxin in patients with heart failure. Rationale and design of the DECISION trial</title><author>Veldhuisen, Dirk J. ; Rienstra, Michiel ; Mosterd, Arend ; Alings, A. Marco ; Asselt, Antoinette D.J. ; Bouvy, Marcel L ; Tijssen, Jan G.P. ; Schaap, Jeroen ; Wall, Ernst E. ; Voors, Adriaan A. ; Boorsma, Eva M. ; Lok, Dirk J.A. ; Crijns, Harry J.G.M. ; Schut, Astrid ; Vijver, Marlene A.T. ; Voordes, Geert H.D. ; Vos, Agaath H. ; Maas‐Soer, Ester L. ; Smit, Nicoline W. ; Touw, Daan J. ; Samuel, Michelle ; Meer, Peter ; Veldhuisen, Dirk J. ; Meer, Peter ; Rienstra, Michiel ; Mosterd, Arend ; Alings, Marco ; Tijssen, Jan ; Asselt, Thea ; Bouvy, Marcel ; Wall, Ernst E. ; Schaap, Jeroen ; Voors, Adriaan A. ; Crijns, Harry J. G. 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G. M.</creatorcontrib><creatorcontrib>Gaillard, Carlo</creatorcontrib><creatorcontrib>Veeger, Nick</creatorcontrib><creatorcontrib>DECISION Investigators and Committees</creatorcontrib><collection>Wiley-Blackwell Open Access Titles</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>European journal of heart failure</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Veldhuisen, Dirk J.</au><au>Rienstra, Michiel</au><au>Mosterd, Arend</au><au>Alings, A. Marco</au><au>Asselt, Antoinette D.J.</au><au>Bouvy, Marcel L</au><au>Tijssen, Jan G.P.</au><au>Schaap, Jeroen</au><au>Wall, Ernst E.</au><au>Voors, Adriaan A.</au><au>Boorsma, Eva M.</au><au>Lok, Dirk J.A.</au><au>Crijns, Harry J.G.M.</au><au>Schut, Astrid</au><au>Vijver, Marlene A.T.</au><au>Voordes, Geert H.D.</au><au>Vos, Agaath H.</au><au>Maas‐Soer, Ester L.</au><au>Smit, Nicoline W.</au><au>Touw, Daan J.</au><au>Samuel, Michelle</au><au>Meer, Peter</au><au>Veldhuisen, Dirk J.</au><au>Meer, Peter</au><au>Rienstra, Michiel</au><au>Mosterd, Arend</au><au>Alings, Marco</au><au>Tijssen, Jan</au><au>Asselt, Thea</au><au>Bouvy, Marcel</au><au>Wall, Ernst E.</au><au>Schaap, Jeroen</au><au>Voors, Adriaan A.</au><au>Crijns, Harry J. G. M.</au><au>Gaillard, Carlo</au><au>Veeger, Nick</au><aucorp>DECISION Investigators and Committees</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and safety of low‐dose digoxin in patients with heart failure. Rationale and design of the DECISION trial</atitle><jtitle>European journal of heart failure</jtitle><addtitle>Eur J Heart Fail</addtitle><date>2024-10</date><risdate>2024</risdate><volume>26</volume><issue>10</issue><spage>2223</spage><epage>2230</epage><pages>2223-2230</pages><issn>1388-9842</issn><issn>1879-0844</issn><eissn>1879-0844</eissn><abstract>Aims
Digoxin is the oldest drug in cardiovascular (CV) medicine, and one trial conducted >25 years ago showed a reduction in heart failure (HF) hospitalizations but no effect on mortality. However, later studies suggested that the dose of digoxin used in that trial (and other studies) may have been too high. The DECISION (Digoxin Evaluation in Chronic heart failure: Investigational Study In Outpatients in the Netherlands) trial will examine the efficacy and safety of low‐dose digoxin in HF patients with reduced or mildly reduced left ventricular ejection fraction (LVEF) with a background of contemporary HF treatment.
Methods
The DECISION trial is a randomized, double‐blind, parallel‐group, placebo‐controlled event‐driven outcome trial which will investigate the efficacy and safety of low‐dose digoxin in patients with chronic HF and LVEF <50%. Both patients with sinus rhythm and atrial fibrillation will be enrolled and will be randomized (1:1) to low‐dose digoxin or matching placebo. To maintain a target serum digoxin concentration of 0.5–0.9 ng/ml, dose adjustments are made throughout follow‐up based on serum digoxin measurements with dummy values for the placebo group. The primary endpoint is a composite of CV mortality and total HF hospitalizations or total urgent hospital visits for worsening HF, and all endpoints are adjudicated blindly by a Clinical Event Committee. The estimated sample size was 982 patients who will be followed for a median of 3 years, and in December 2023 enrolment was completed after 1002 patients.
Conclusions
The DECISION trial will provide important evidence regarding the effect of (low‐dose) digoxin on CV mortality and total HF hospitalizations and urgent hospital visits when added to contemporary HF treatment of patients with reduced or mildly reduced LVEF.
Clinical Trial Registration: ClinicalTrials.gov identifier: NCT03783429.
Rationale and design of the DECISION trial. ECG, electrocardiogram; HF, heart failure; LVEF, left ventricular ejection fraction; NT‐proBNP, N‐terminal pro‐B‐type natriuretic peptide; NYHA, New York Heart Association.</abstract><cop>Oxford, UK</cop><pub>John Wiley & Sons, Ltd</pub><pmid>39212246</pmid><doi>10.1002/ejhf.3428</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| identifier | ISSN: 1388-9842 |
| ispartof | European journal of heart failure, 2024-10, Vol.26 (10), p.2223-2230 |
| issn | 1388-9842 1879-0844 1879-0844 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_3099805339 |
| source | MEDLINE; Wiley Online Library Journals Frontfile Complete; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals |
| subjects | Aged Cardiotonic Agents - administration & dosage Cardiotonic Agents - therapeutic use Digoxin Digoxin - administration & dosage Digoxin - adverse effects Digoxin - therapeutic use Dose-Response Relationship, Drug Double-Blind Method Female Heart failure Heart Failure - drug therapy Heart Failure - mortality Heart Failure - physiopathology Hospitalization - statistics & numerical data Hospitalizations Humans Low‐dose Male Middle Aged Mortality Netherlands - epidemiology Randomized clinical trial Stroke Volume - physiology Treatment Outcome Ventricular Function, Left - drug effects Ventricular Function, Left - physiology |
| title | Efficacy and safety of low‐dose digoxin in patients with heart failure. Rationale and design of the DECISION trial |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-05T01%3A23%3A16IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Efficacy%20and%20safety%20of%20low%E2%80%90dose%20digoxin%20in%20patients%20with%20heart%20failure.%20Rationale%20and%20design%20of%20the%20DECISION%20trial&rft.jtitle=European%20journal%20of%20heart%20failure&rft.au=Veldhuisen,%20Dirk%20J.&rft.aucorp=DECISION%20Investigators%20and%20Committees&rft.date=2024-10&rft.volume=26&rft.issue=10&rft.spage=2223&rft.epage=2230&rft.pages=2223-2230&rft.issn=1388-9842&rft.eissn=1879-0844&rft_id=info:doi/10.1002/ejhf.3428&rft_dat=%3Cproquest_cross%3E3099805339%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=3099805339&rft_id=info:pmid/39212246&rfr_iscdi=true |