Rationale and design of the Study of Dietary Intervention Under 100 MMOL in Heart Failure (SODIUM-HF)
Patients with heart failure (HF) remain at high risk for future events despite medical and device therapy. Dietary sodium reduction is often recommended based on limited evidence. However, it is not known whether dietary sodium reduction reduces the morbidity or mortality associated with HF. The SOD...
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| Veröffentlicht in: | The American heart journal 2018-11, Vol.205, p.87-96 |
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| creator | Colin-Ramirez, Eloisa Ezekowitz, Justin A. |
| description | Patients with heart failure (HF) remain at high risk for future events despite medical and device therapy. Dietary sodium reduction is often recommended based on limited evidence. However, it is not known whether dietary sodium reduction reduces the morbidity or mortality associated with HF.
The SODIUM study is a pragmatic, randomized, open-label trial assessing the efficacy of dietary sodium reduction to |
| doi_str_mv | 10.1016/j.ahj.2018.08.005 |
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The SODIUM study is a pragmatic, randomized, open-label trial assessing the efficacy of dietary sodium reduction to <1500 mg daily counseling compared to usual care for patients with chronic HF. The intervention is provided by trained personnel at the site and uses 3-day food records for directing counseling. The primary outcome is an intention-to-treat analysis on the time to first cardiovascular event or death measured at 12 months. Secondary end points include the change in quality of life (using the Kansas City Cardiomyopathy Questionnaire), change in New York Heart Association class, and change in 6-minute walk test. The first patient was enrolled in March 2014, and subsequently, 27 sites in 6 countries enrolled patients.
The SODIUM-HF trial will provide a robust evaluation of the effects of dietary sodium reduction in patients with HF. Results are expected in 2020.</description><identifier>ISSN: 0002-8703</identifier><identifier>EISSN: 1097-6744</identifier><identifier>DOI: 10.1016/j.ahj.2018.08.005</identifier><identifier>PMID: 30205241</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Aged ; Cardiology ; Cardiomyopathy ; Clinical outcomes ; Clinical trials ; Dementia ; Diet ; Diet, Sodium-Restricted - methods ; Dietitians ; Female ; Health sciences ; Heart ; Heart diseases ; Heart failure ; Heart Failure - diet therapy ; Heart Failure - physiopathology ; Hospitalization - statistics & numerical data ; Hospitals ; Humans ; Institutionalization ; Intervention ; Male ; Meals ; Medical electronics ; Medical research ; Middle Aged ; Morbidity ; Mortality ; Motivation ; Patients ; Population ; Quality of Life ; Reduction ; Society ; Sodium ; Stroke Volume - physiology ; Thyroid gland ; Treatment Outcome ; Walk Test</subject><ispartof>The American heart journal, 2018-11, Vol.205, p.87-96</ispartof><rights>2018 Elsevier Inc.</rights><rights>Copyright © 2018 Elsevier Inc. All rights reserved.</rights><rights>2018. Elsevier Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c381t-6443f399582daa689fd54f9537f3c6a26b9a95f707a427c662961b9127e30b7d3</citedby><cites>FETCH-LOGICAL-c381t-6443f399582daa689fd54f9537f3c6a26b9a95f707a427c662961b9127e30b7d3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/2140508085?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995,64385,64387,64389,72341</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30205241$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Colin-Ramirez, Eloisa</creatorcontrib><creatorcontrib>Ezekowitz, Justin A.</creatorcontrib><creatorcontrib>on behalf of the SODIUM-HF investigators</creatorcontrib><creatorcontrib>SODIUM-HF investigators</creatorcontrib><title>Rationale and design of the Study of Dietary Intervention Under 100 MMOL in Heart Failure (SODIUM-HF)</title><title>The American heart journal</title><addtitle>Am Heart J</addtitle><description>Patients with heart failure (HF) remain at high risk for future events despite medical and device therapy. Dietary sodium reduction is often recommended based on limited evidence. However, it is not known whether dietary sodium reduction reduces the morbidity or mortality associated with HF.
The SODIUM study is a pragmatic, randomized, open-label trial assessing the efficacy of dietary sodium reduction to <1500 mg daily counseling compared to usual care for patients with chronic HF. The intervention is provided by trained personnel at the site and uses 3-day food records for directing counseling. The primary outcome is an intention-to-treat analysis on the time to first cardiovascular event or death measured at 12 months. Secondary end points include the change in quality of life (using the Kansas City Cardiomyopathy Questionnaire), change in New York Heart Association class, and change in 6-minute walk test. The first patient was enrolled in March 2014, and subsequently, 27 sites in 6 countries enrolled patients.
The SODIUM-HF trial will provide a robust evaluation of the effects of dietary sodium reduction in patients with HF. Results are expected in 2020.</description><subject>Aged</subject><subject>Cardiology</subject><subject>Cardiomyopathy</subject><subject>Clinical outcomes</subject><subject>Clinical trials</subject><subject>Dementia</subject><subject>Diet</subject><subject>Diet, Sodium-Restricted - methods</subject><subject>Dietitians</subject><subject>Female</subject><subject>Health sciences</subject><subject>Heart</subject><subject>Heart diseases</subject><subject>Heart failure</subject><subject>Heart Failure - diet therapy</subject><subject>Heart Failure - physiopathology</subject><subject>Hospitalization - statistics & numerical data</subject><subject>Hospitals</subject><subject>Humans</subject><subject>Institutionalization</subject><subject>Intervention</subject><subject>Male</subject><subject>Meals</subject><subject>Medical electronics</subject><subject>Medical research</subject><subject>Middle Aged</subject><subject>Morbidity</subject><subject>Mortality</subject><subject>Motivation</subject><subject>Patients</subject><subject>Population</subject><subject>Quality of Life</subject><subject>Reduction</subject><subject>Society</subject><subject>Sodium</subject><subject>Stroke Volume - physiology</subject><subject>Thyroid gland</subject><subject>Treatment Outcome</subject><subject>Walk Test</subject><issn>0002-8703</issn><issn>1097-6744</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNp9kUFr3DAUhEVpabZpf0AvRdBLevD2SbJliZ5C0u0u7LLQdM9Caz03Ml45lexA_n1lNu2hh8LA48E3c5gh5D2DJQMmP3dLe98tOTC1hCyoXpAFA10Xsi7Ll2QBALxQNYgL8ialLr-SK_maXAjgUPGSLQh-t6Mfgu2R2uCow-R_Bjq0dLxHejdO7ml-bj2ONj7RTRgxPmKYLfQQHEbKAOhut99SH-gabRzpyvp-ikiv7va3m8OuWK8-vSWvWtsnfPd8L8lh9fXHzbrY7r9tbq63RSMUGwtZlqIVWleKO2ul0q2rylZXom5FIy2XR2111dZQ25LXjZRcS3bUjNco4Fg7cUmuzrkPcfg1YRrNyacG-94GHKZkOAOumdKgMvrxH7QbppiLmKkSKlCgqkyxM9XEIaWIrXmI_pSrMAzMvIHpTN7AzBsYyILZ8-E5eTqe0P11_Ck9A1_OAOYqHj1GkxqPoUHnIzajcYP_T_xvNOmSYQ</recordid><startdate>201811</startdate><enddate>201811</enddate><creator>Colin-Ramirez, Eloisa</creator><creator>Ezekowitz, Justin A.</creator><general>Elsevier Inc</general><general>Elsevier Limited</general><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>3V.</scope><scope>7QO</scope><scope>7RV</scope><scope>7TS</scope><scope>7X7</scope><scope>7XB</scope><scope>88C</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AN0</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M0T</scope><scope>M1P</scope><scope>M2O</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>P64</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>7X8</scope></search><sort><creationdate>201811</creationdate><title>Rationale and design of the Study of Dietary Intervention Under 100 MMOL in Heart Failure (SODIUM-HF)</title><author>Colin-Ramirez, Eloisa ; Ezekowitz, Justin A.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c381t-6443f399582daa689fd54f9537f3c6a26b9a95f707a427c662961b9127e30b7d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Aged</topic><topic>Cardiology</topic><topic>Cardiomyopathy</topic><topic>Clinical outcomes</topic><topic>Clinical trials</topic><topic>Dementia</topic><topic>Diet</topic><topic>Diet, Sodium-Restricted - methods</topic><topic>Dietitians</topic><topic>Female</topic><topic>Health sciences</topic><topic>Heart</topic><topic>Heart diseases</topic><topic>Heart failure</topic><topic>Heart Failure - diet therapy</topic><topic>Heart Failure - physiopathology</topic><topic>Hospitalization - statistics & numerical data</topic><topic>Hospitals</topic><topic>Humans</topic><topic>Institutionalization</topic><topic>Intervention</topic><topic>Male</topic><topic>Meals</topic><topic>Medical electronics</topic><topic>Medical research</topic><topic>Middle Aged</topic><topic>Morbidity</topic><topic>Mortality</topic><topic>Motivation</topic><topic>Patients</topic><topic>Population</topic><topic>Quality of Life</topic><topic>Reduction</topic><topic>Society</topic><topic>Sodium</topic><topic>Stroke Volume - physiology</topic><topic>Thyroid gland</topic><topic>Treatment Outcome</topic><topic>Walk Test</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Colin-Ramirez, Eloisa</creatorcontrib><creatorcontrib>Ezekowitz, Justin A.</creatorcontrib><creatorcontrib>on behalf of the SODIUM-HF investigators</creatorcontrib><creatorcontrib>SODIUM-HF investigators</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Biotechnology Research Abstracts</collection><collection>Proquest Nursing & Allied Health Source</collection><collection>Physical Education Index</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Healthcare Administration Database (Alumni)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Technology Research Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>British Nursing Database</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Healthcare Administration Database</collection><collection>Medical Database</collection><collection>Research Library</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><jtitle>The American heart journal</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Colin-Ramirez, Eloisa</au><au>Ezekowitz, Justin A.</au><aucorp>on behalf of the SODIUM-HF investigators</aucorp><aucorp>SODIUM-HF investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Rationale and design of the Study of Dietary Intervention Under 100 MMOL in Heart Failure (SODIUM-HF)</atitle><jtitle>The American heart journal</jtitle><addtitle>Am Heart J</addtitle><date>2018-11</date><risdate>2018</risdate><volume>205</volume><spage>87</spage><epage>96</epage><pages>87-96</pages><issn>0002-8703</issn><eissn>1097-6744</eissn><abstract>Patients with heart failure (HF) remain at high risk for future events despite medical and device therapy. Dietary sodium reduction is often recommended based on limited evidence. However, it is not known whether dietary sodium reduction reduces the morbidity or mortality associated with HF.
The SODIUM study is a pragmatic, randomized, open-label trial assessing the efficacy of dietary sodium reduction to <1500 mg daily counseling compared to usual care for patients with chronic HF. The intervention is provided by trained personnel at the site and uses 3-day food records for directing counseling. The primary outcome is an intention-to-treat analysis on the time to first cardiovascular event or death measured at 12 months. Secondary end points include the change in quality of life (using the Kansas City Cardiomyopathy Questionnaire), change in New York Heart Association class, and change in 6-minute walk test. The first patient was enrolled in March 2014, and subsequently, 27 sites in 6 countries enrolled patients.
The SODIUM-HF trial will provide a robust evaluation of the effects of dietary sodium reduction in patients with HF. Results are expected in 2020.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>30205241</pmid><doi>10.1016/j.ahj.2018.08.005</doi><tpages>10</tpages></addata></record> |
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| subjects | Aged Cardiology Cardiomyopathy Clinical outcomes Clinical trials Dementia Diet Diet, Sodium-Restricted - methods Dietitians Female Health sciences Heart Heart diseases Heart failure Heart Failure - diet therapy Heart Failure - physiopathology Hospitalization - statistics & numerical data Hospitals Humans Institutionalization Intervention Male Meals Medical electronics Medical research Middle Aged Morbidity Mortality Motivation Patients Population Quality of Life Reduction Society Sodium Stroke Volume - physiology Thyroid gland Treatment Outcome Walk Test |
| title | Rationale and design of the Study of Dietary Intervention Under 100 MMOL in Heart Failure (SODIUM-HF) |
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