Short-term Intravenous Milrinone for Acute Exacerbation of Chronic Heart Failure: A Randomized Controlled Trial
CONTEXT Little randomized evidence is available to guide the in-hospital management of patients with an acute exacerbation of chronic heart failure. Although intravenous inotropic therapy usually produces beneficial hemodynamic effects and is labeled for use in the care of such patients, the effect...
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| creator | Cuffe, Michael S Califf, Robert M Adams, Jr, Kirkwood F Benza, Raymond Bourge, Robert Colucci, Wilson S Massie, Barry M O'Connor, Christopher M Pina, Ileana Quigg, Rebecca Silver, Marc A Gheorghiade, Mihai |
| description | CONTEXT Little randomized evidence is available to guide the in-hospital management
of patients with an acute exacerbation of chronic heart failure. Although
intravenous inotropic therapy usually produces beneficial hemodynamic effects
and is labeled for use in the care of such patients, the effect of such therapy
on intermediate-term clinical outcomes is uncertain. OBJECTIVE To prospectively test whether a strategy that includes short-term use
of milrinone in addition to standard therapy can improve clinical outcomes
of patients hospitalized with an exacerbation of chronic heart failure. DESIGN Prospective, randomized, double-blind, placebo-controlled trial conducted
from July 1997 through November 1999. SETTING Seventy-eight community and tertiary care hospitals in the United States. PARTICIPANTS A total of 951 patients admitted with an exacerbation of systolic heart
failure not requiring intravenous inotropic support (mean age, 65 years; 92%
with baseline New York Heart Association class III or IV; mean left ventricular
ejection fraction, 23%). INTERVENTION Patients were randomly assigned to receive a 48-hour infusion of either
milrinone, 0.5 µg/kg per minute initially (n = 477), or saline placebo
(n = 472). MAIN OUTCOME MEASURE Cumulative days of hospitalization for cardiovascular cause within 60
days following randomization. RESULTS The median number of days hospitalized for cardiovascular causes within
60 days after randomization did not differ significantly between patients
given milrinone (6 days) compared with placebo (7 days; P = .71). Sustained hypotension requiring intervention (10.7% vs 3.2%; P |
| doi_str_mv | 10.1001/jama.287.12.1541 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_proquest_journals_211374834</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><ama_id>194768</ama_id><sourcerecordid>111729490</sourcerecordid><originalsourceid>FETCH-LOGICAL-a371t-8cc9dcbf5748e8705fc0d67aec486e44204d957e33a7c859fccb5dec0d75e39a3</originalsourceid><addsrcrecordid>eNpF0UtLAzEQAOAgiq2Pu14kCB63Jk3SJN5K8QWKoPVcptlZmrKbaHZX1F9vpBVzmcB8zAwzhJxwNuKM8cs1NDAaGz3i4xFXku-QIVfCFEJZs0uGjFlTaGnkgBy07Zrlx4XeJwPOLedaTYYkvqxi6ooOU0PvQ5fgA0PsW_ro6-RDDEirmOjU9R3S609wmJbQ-RhorOhslWLwjt4hpI7egK_7hFd0Sp8hlLHx31jSWcxFY13n7zx5qI_IXgV1i8fbeEheb67ns7vi4en2fjZ9KEBo3hXGOVu6ZaXy9Gg0U5Vj5UQDOmkmKOWYydIqjUKAdkbZyrmlKjEjrVBYEIfkfFP3LcX3HttusY59CrnlYszzEqQRMqOzLeqXDZaLt-QbSF-Lv_VkcLEF0DqoqwTB-fbfiWys-HWnG5fv8Z-1Uk-M-AEApH3C</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>211374834</pqid></control><display><type>article</type><title>Short-term Intravenous Milrinone for Acute Exacerbation of Chronic Heart Failure: A Randomized Controlled Trial</title><source>MEDLINE</source><source>American Medical Association Journals</source><creator>Cuffe, Michael S ; Califf, Robert M ; Adams, Jr, Kirkwood F ; Benza, Raymond ; Bourge, Robert ; Colucci, Wilson S ; Massie, Barry M ; O'Connor, Christopher M ; Pina, Ileana ; Quigg, Rebecca ; Silver, Marc A ; Gheorghiade, Mihai</creator><creatorcontrib>Cuffe, Michael S ; Califf, Robert M ; Adams, Jr, Kirkwood F ; Benza, Raymond ; Bourge, Robert ; Colucci, Wilson S ; Massie, Barry M ; O'Connor, Christopher M ; Pina, Ileana ; Quigg, Rebecca ; Silver, Marc A ; Gheorghiade, Mihai ; Outcomes of a Prospective Trial of Intravenous Milrinone for Exacerbations of Chronic Heart Failure (OPTIME-CHF) Investigators</creatorcontrib><description>CONTEXT Little randomized evidence is available to guide the in-hospital management
of patients with an acute exacerbation of chronic heart failure. Although
intravenous inotropic therapy usually produces beneficial hemodynamic effects
and is labeled for use in the care of such patients, the effect of such therapy
on intermediate-term clinical outcomes is uncertain. OBJECTIVE To prospectively test whether a strategy that includes short-term use
of milrinone in addition to standard therapy can improve clinical outcomes
of patients hospitalized with an exacerbation of chronic heart failure. DESIGN Prospective, randomized, double-blind, placebo-controlled trial conducted
from July 1997 through November 1999. SETTING Seventy-eight community and tertiary care hospitals in the United States. PARTICIPANTS A total of 951 patients admitted with an exacerbation of systolic heart
failure not requiring intravenous inotropic support (mean age, 65 years; 92%
with baseline New York Heart Association class III or IV; mean left ventricular
ejection fraction, 23%). INTERVENTION Patients were randomly assigned to receive a 48-hour infusion of either
milrinone, 0.5 µg/kg per minute initially (n = 477), or saline placebo
(n = 472). MAIN OUTCOME MEASURE Cumulative days of hospitalization for cardiovascular cause within 60
days following randomization. RESULTS The median number of days hospitalized for cardiovascular causes within
60 days after randomization did not differ significantly between patients
given milrinone (6 days) compared with placebo (7 days; P = .71). Sustained hypotension requiring intervention (10.7% vs 3.2%; P<.001) and new atrial arrhythmias (4.6% vs 1.5%; P = .004) occurred more frequently in patients who received
milrinone. The milrinone and placebo groups did not differ significantly in
in-hospital mortality (3.8% vs 2.3%; P = .19), 60-day
mortality (10.3% vs 8.9%; P = .41), or the composite
incidence of death or readmission (35.0% vs 35.3%; P
= .92) CONCLUSION These results do not support the routine use of intravenous milrinone
as an adjunct to standard therapy in the treatment of patients hospitalized
for an exacerbation of chronic heart failure.</description><identifier>ISSN: 0098-7484</identifier><identifier>EISSN: 1538-3598</identifier><identifier>DOI: 10.1001/jama.287.12.1541</identifier><identifier>PMID: 11911756</identifier><identifier>CODEN: JAMAAP</identifier><language>eng</language><publisher>Chicago, IL: American Medical Association</publisher><subject>Acute Disease ; Aged ; Biological and medical sciences ; Cardiotonic agents ; Cardiotonic Agents - administration & dosage ; Cardiotonic Agents - adverse effects ; Cardiotonic Agents - therapeutic use ; Cardiovascular system ; Clinical outcomes ; Double-Blind Method ; Drug therapy ; Drug Therapy, Combination ; Female ; Heart failure ; Heart Failure - drug therapy ; Hospitalization ; Humans ; Infusions, Intravenous ; Male ; Medical research ; Medical sciences ; Middle Aged ; Milrinone - adverse effects ; Milrinone - therapeutic use ; Pharmacology. Drug treatments ; Proportional Hazards Models ; Prospective Studies ; Treatment Failure</subject><ispartof>JAMA : the journal of the American Medical Association, 2002-03, Vol.287 (12), p.1541-1547</ispartof><rights>2002 INIST-CNRS</rights><rights>Copyright American Medical Association Mar 27, 2002</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-a371t-8cc9dcbf5748e8705fc0d67aec486e44204d957e33a7c859fccb5dec0d75e39a3</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://jamanetwork.com/journals/jama/articlepdf/10.1001/jama.287.12.1541$$EPDF$$P50$$Gama$$H</linktopdf><linktohtml>$$Uhttps://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.287.12.1541$$EHTML$$P50$$Gama$$H</linktohtml><link.rule.ids>64,314,776,780,3327,27901,27902,76232,76235</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=13563936$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/11911756$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Cuffe, Michael S</creatorcontrib><creatorcontrib>Califf, Robert M</creatorcontrib><creatorcontrib>Adams, Jr, Kirkwood F</creatorcontrib><creatorcontrib>Benza, Raymond</creatorcontrib><creatorcontrib>Bourge, Robert</creatorcontrib><creatorcontrib>Colucci, Wilson S</creatorcontrib><creatorcontrib>Massie, Barry M</creatorcontrib><creatorcontrib>O'Connor, Christopher M</creatorcontrib><creatorcontrib>Pina, Ileana</creatorcontrib><creatorcontrib>Quigg, Rebecca</creatorcontrib><creatorcontrib>Silver, Marc A</creatorcontrib><creatorcontrib>Gheorghiade, Mihai</creatorcontrib><creatorcontrib>Outcomes of a Prospective Trial of Intravenous Milrinone for Exacerbations of Chronic Heart Failure (OPTIME-CHF) Investigators</creatorcontrib><title>Short-term Intravenous Milrinone for Acute Exacerbation of Chronic Heart Failure: A Randomized Controlled Trial</title><title>JAMA : the journal of the American Medical Association</title><addtitle>JAMA</addtitle><description>CONTEXT Little randomized evidence is available to guide the in-hospital management
of patients with an acute exacerbation of chronic heart failure. Although
intravenous inotropic therapy usually produces beneficial hemodynamic effects
and is labeled for use in the care of such patients, the effect of such therapy
on intermediate-term clinical outcomes is uncertain. OBJECTIVE To prospectively test whether a strategy that includes short-term use
of milrinone in addition to standard therapy can improve clinical outcomes
of patients hospitalized with an exacerbation of chronic heart failure. DESIGN Prospective, randomized, double-blind, placebo-controlled trial conducted
from July 1997 through November 1999. SETTING Seventy-eight community and tertiary care hospitals in the United States. PARTICIPANTS A total of 951 patients admitted with an exacerbation of systolic heart
failure not requiring intravenous inotropic support (mean age, 65 years; 92%
with baseline New York Heart Association class III or IV; mean left ventricular
ejection fraction, 23%). INTERVENTION Patients were randomly assigned to receive a 48-hour infusion of either
milrinone, 0.5 µg/kg per minute initially (n = 477), or saline placebo
(n = 472). MAIN OUTCOME MEASURE Cumulative days of hospitalization for cardiovascular cause within 60
days following randomization. RESULTS The median number of days hospitalized for cardiovascular causes within
60 days after randomization did not differ significantly between patients
given milrinone (6 days) compared with placebo (7 days; P = .71). Sustained hypotension requiring intervention (10.7% vs 3.2%; P<.001) and new atrial arrhythmias (4.6% vs 1.5%; P = .004) occurred more frequently in patients who received
milrinone. The milrinone and placebo groups did not differ significantly in
in-hospital mortality (3.8% vs 2.3%; P = .19), 60-day
mortality (10.3% vs 8.9%; P = .41), or the composite
incidence of death or readmission (35.0% vs 35.3%; P
= .92) CONCLUSION These results do not support the routine use of intravenous milrinone
as an adjunct to standard therapy in the treatment of patients hospitalized
for an exacerbation of chronic heart failure.</description><subject>Acute Disease</subject><subject>Aged</subject><subject>Biological and medical sciences</subject><subject>Cardiotonic agents</subject><subject>Cardiotonic Agents - administration & dosage</subject><subject>Cardiotonic Agents - adverse effects</subject><subject>Cardiotonic Agents - therapeutic use</subject><subject>Cardiovascular system</subject><subject>Clinical outcomes</subject><subject>Double-Blind Method</subject><subject>Drug therapy</subject><subject>Drug Therapy, Combination</subject><subject>Female</subject><subject>Heart failure</subject><subject>Heart Failure - drug therapy</subject><subject>Hospitalization</subject><subject>Humans</subject><subject>Infusions, Intravenous</subject><subject>Male</subject><subject>Medical research</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Milrinone - adverse effects</subject><subject>Milrinone - therapeutic use</subject><subject>Pharmacology. Drug treatments</subject><subject>Proportional Hazards Models</subject><subject>Prospective Studies</subject><subject>Treatment Failure</subject><issn>0098-7484</issn><issn>1538-3598</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2002</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpF0UtLAzEQAOAgiq2Pu14kCB63Jk3SJN5K8QWKoPVcptlZmrKbaHZX1F9vpBVzmcB8zAwzhJxwNuKM8cs1NDAaGz3i4xFXku-QIVfCFEJZs0uGjFlTaGnkgBy07Zrlx4XeJwPOLedaTYYkvqxi6ooOU0PvQ5fgA0PsW_ro6-RDDEirmOjU9R3S609wmJbQ-RhorOhslWLwjt4hpI7egK_7hFd0Sp8hlLHx31jSWcxFY13n7zx5qI_IXgV1i8fbeEheb67ns7vi4en2fjZ9KEBo3hXGOVu6ZaXy9Gg0U5Vj5UQDOmkmKOWYydIqjUKAdkbZyrmlKjEjrVBYEIfkfFP3LcX3HttusY59CrnlYszzEqQRMqOzLeqXDZaLt-QbSF-Lv_VkcLEF0DqoqwTB-fbfiWys-HWnG5fv8Z-1Uk-M-AEApH3C</recordid><startdate>20020327</startdate><enddate>20020327</enddate><creator>Cuffe, Michael S</creator><creator>Califf, Robert M</creator><creator>Adams, Jr, Kirkwood F</creator><creator>Benza, Raymond</creator><creator>Bourge, Robert</creator><creator>Colucci, Wilson S</creator><creator>Massie, Barry M</creator><creator>O'Connor, Christopher M</creator><creator>Pina, Ileana</creator><creator>Quigg, Rebecca</creator><creator>Silver, Marc A</creator><creator>Gheorghiade, Mihai</creator><general>American Medical Association</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7QL</scope><scope>7QP</scope><scope>7TK</scope><scope>7TS</scope><scope>7U7</scope><scope>7U9</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>H94</scope><scope>K9.</scope><scope>M7N</scope><scope>NAPCQ</scope><scope>P64</scope><scope>RC3</scope></search><sort><creationdate>20020327</creationdate><title>Short-term Intravenous Milrinone for Acute Exacerbation of Chronic Heart Failure: A Randomized Controlled Trial</title><author>Cuffe, Michael S ; Califf, Robert M ; Adams, Jr, Kirkwood F ; Benza, Raymond ; Bourge, Robert ; Colucci, Wilson S ; Massie, Barry M ; O'Connor, Christopher M ; Pina, Ileana ; Quigg, Rebecca ; Silver, Marc A ; Gheorghiade, Mihai</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-a371t-8cc9dcbf5748e8705fc0d67aec486e44204d957e33a7c859fccb5dec0d75e39a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2002</creationdate><topic>Acute Disease</topic><topic>Aged</topic><topic>Biological and medical sciences</topic><topic>Cardiotonic agents</topic><topic>Cardiotonic Agents - administration & dosage</topic><topic>Cardiotonic Agents - adverse effects</topic><topic>Cardiotonic Agents - therapeutic use</topic><topic>Cardiovascular system</topic><topic>Clinical outcomes</topic><topic>Double-Blind Method</topic><topic>Drug therapy</topic><topic>Drug Therapy, Combination</topic><topic>Female</topic><topic>Heart failure</topic><topic>Heart Failure - drug therapy</topic><topic>Hospitalization</topic><topic>Humans</topic><topic>Infusions, Intravenous</topic><topic>Male</topic><topic>Medical research</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Milrinone - adverse effects</topic><topic>Milrinone - therapeutic use</topic><topic>Pharmacology. Drug treatments</topic><topic>Proportional Hazards Models</topic><topic>Prospective Studies</topic><topic>Treatment Failure</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Cuffe, Michael S</creatorcontrib><creatorcontrib>Califf, Robert M</creatorcontrib><creatorcontrib>Adams, Jr, Kirkwood F</creatorcontrib><creatorcontrib>Benza, Raymond</creatorcontrib><creatorcontrib>Bourge, Robert</creatorcontrib><creatorcontrib>Colucci, Wilson S</creatorcontrib><creatorcontrib>Massie, Barry M</creatorcontrib><creatorcontrib>O'Connor, Christopher M</creatorcontrib><creatorcontrib>Pina, Ileana</creatorcontrib><creatorcontrib>Quigg, Rebecca</creatorcontrib><creatorcontrib>Silver, Marc A</creatorcontrib><creatorcontrib>Gheorghiade, Mihai</creatorcontrib><creatorcontrib>Outcomes of a Prospective Trial of Intravenous Milrinone for Exacerbations of Chronic Heart Failure (OPTIME-CHF) Investigators</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>Physical Education Index</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Technology Research Database</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Genetics Abstracts</collection><jtitle>JAMA : the journal of the American Medical Association</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Cuffe, Michael S</au><au>Califf, Robert M</au><au>Adams, Jr, Kirkwood F</au><au>Benza, Raymond</au><au>Bourge, Robert</au><au>Colucci, Wilson S</au><au>Massie, Barry M</au><au>O'Connor, Christopher M</au><au>Pina, Ileana</au><au>Quigg, Rebecca</au><au>Silver, Marc A</au><au>Gheorghiade, Mihai</au><aucorp>Outcomes of a Prospective Trial of Intravenous Milrinone for Exacerbations of Chronic Heart Failure (OPTIME-CHF) Investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Short-term Intravenous Milrinone for Acute Exacerbation of Chronic Heart Failure: A Randomized Controlled Trial</atitle><jtitle>JAMA : the journal of the American Medical Association</jtitle><addtitle>JAMA</addtitle><date>2002-03-27</date><risdate>2002</risdate><volume>287</volume><issue>12</issue><spage>1541</spage><epage>1547</epage><pages>1541-1547</pages><issn>0098-7484</issn><eissn>1538-3598</eissn><coden>JAMAAP</coden><abstract>CONTEXT Little randomized evidence is available to guide the in-hospital management
of patients with an acute exacerbation of chronic heart failure. Although
intravenous inotropic therapy usually produces beneficial hemodynamic effects
and is labeled for use in the care of such patients, the effect of such therapy
on intermediate-term clinical outcomes is uncertain. OBJECTIVE To prospectively test whether a strategy that includes short-term use
of milrinone in addition to standard therapy can improve clinical outcomes
of patients hospitalized with an exacerbation of chronic heart failure. DESIGN Prospective, randomized, double-blind, placebo-controlled trial conducted
from July 1997 through November 1999. SETTING Seventy-eight community and tertiary care hospitals in the United States. PARTICIPANTS A total of 951 patients admitted with an exacerbation of systolic heart
failure not requiring intravenous inotropic support (mean age, 65 years; 92%
with baseline New York Heart Association class III or IV; mean left ventricular
ejection fraction, 23%). INTERVENTION Patients were randomly assigned to receive a 48-hour infusion of either
milrinone, 0.5 µg/kg per minute initially (n = 477), or saline placebo
(n = 472). MAIN OUTCOME MEASURE Cumulative days of hospitalization for cardiovascular cause within 60
days following randomization. RESULTS The median number of days hospitalized for cardiovascular causes within
60 days after randomization did not differ significantly between patients
given milrinone (6 days) compared with placebo (7 days; P = .71). Sustained hypotension requiring intervention (10.7% vs 3.2%; P<.001) and new atrial arrhythmias (4.6% vs 1.5%; P = .004) occurred more frequently in patients who received
milrinone. The milrinone and placebo groups did not differ significantly in
in-hospital mortality (3.8% vs 2.3%; P = .19), 60-day
mortality (10.3% vs 8.9%; P = .41), or the composite
incidence of death or readmission (35.0% vs 35.3%; P
= .92) CONCLUSION These results do not support the routine use of intravenous milrinone
as an adjunct to standard therapy in the treatment of patients hospitalized
for an exacerbation of chronic heart failure.</abstract><cop>Chicago, IL</cop><pub>American Medical Association</pub><pmid>11911756</pmid><doi>10.1001/jama.287.12.1541</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0098-7484 |
| ispartof | JAMA : the journal of the American Medical Association, 2002-03, Vol.287 (12), p.1541-1547 |
| issn | 0098-7484 1538-3598 |
| language | eng |
| recordid | cdi_proquest_journals_211374834 |
| source | MEDLINE; American Medical Association Journals |
| subjects | Acute Disease Aged Biological and medical sciences Cardiotonic agents Cardiotonic Agents - administration & dosage Cardiotonic Agents - adverse effects Cardiotonic Agents - therapeutic use Cardiovascular system Clinical outcomes Double-Blind Method Drug therapy Drug Therapy, Combination Female Heart failure Heart Failure - drug therapy Hospitalization Humans Infusions, Intravenous Male Medical research Medical sciences Middle Aged Milrinone - adverse effects Milrinone - therapeutic use Pharmacology. Drug treatments Proportional Hazards Models Prospective Studies Treatment Failure |
| title | Short-term Intravenous Milrinone for Acute Exacerbation of Chronic Heart Failure: A Randomized Controlled Trial |
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