Vitamin D Therapy and Cardiac Structure and Function in Patients With Chronic Kidney Disease: The PRIMO Randomized Controlled Trial
CONTEXT Vitamin D is associated with decreased cardiovascular-related morbidity and mortality, possibly by modifying cardiac structure and function, yet firm evidence for either remains lacking. OBJECTIVE To determine the effects of an active vitamin D compound, paricalcitol, on left ventricular mas...
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creator | Thadhani, Ravi Appelbaum, Evan Pritchett, Yili Chang, Yuchiao Wenger, Julia Tamez, Hector Bhan, Ishir Agarwal, Rajiv Zoccali, Carmine Wanner, Christoph Lloyd-Jones, Donald Cannata, Jorge Thompson, B. Taylor Andress, Dennis Zhang, Wuyan Packham, David Singh, Bhupinder Zehnder, Daniel Shah, Amil Pachika, Ajay Manning, Warren J Solomon, Scott D |
description | CONTEXT Vitamin D is associated with decreased cardiovascular-related morbidity and mortality, possibly by modifying cardiac structure and function, yet firm evidence for either remains lacking. OBJECTIVE To determine the effects of an active vitamin D compound, paricalcitol, on left ventricular mass over 48 weeks in patients with an estimated glomerular filtration rate of 15 to 60 mL/min/1.73 m2. DESIGN, SETTING, AND PARTICIPANTS Multinational, double-blind, randomized placebo-controlled trial among 227 patients with chronic kidney disease, mild to moderate left ventricular hypertrophy, and preserved left ventricular ejection fraction, conducted in 11 countries from July 2008 through September 2010. INTERVENTION Participants were randomly assigned to receive oral paricalcitol, 2 μg/d (n =115), or matching placebo (n = 112). MAIN OUTCOME MEASURES Change in left ventricular mass index over 48 weeks by cardiovascular magnetic resonance imaging. Secondary end points included echocardiographic changes in left ventricular diastolic function. RESULTS Treatment with paricalcitol reduced parathyroid hormone levels within 4 weeks and maintained levels within the normal range throughout the study duration. At 48 weeks, the change in left ventricular mass index did not differ between treatment groups (paricalcitol group, 0.34 g/m2.7 [95% CI, −0.14 to 0.83 g/m2.7] vs placebo group, −0.07 g/m2.7 [95% CI, −0.55 to 0.42 g/m2.7]). Doppler measures of diastolic function including peak early diastolic lateral mitral annular tissue velocity (paricalcitol group, −0.01 cm/s [95% CI, −0.63 to 0.60 cm/s] vs placebo group, −0.30 cm/s [95% CI, −0.93 to 0.34 cm/s]) also did not differ. Episodes of hypercalcemia were more frequent in the paricalcitol group compared with the placebo group. CONCLUSION Forty-eight week therapy with paricalcitol did not alter left ventricular mass index or improve certain measures of diastolic dysfunction in patients with chronic kidney disease. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00497146 |
doi_str_mv | 10.1001/jama.2012.120 |
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Taylor ; Andress, Dennis ; Zhang, Wuyan ; Packham, David ; Singh, Bhupinder ; Zehnder, Daniel ; Shah, Amil ; Pachika, Ajay ; Manning, Warren J ; Solomon, Scott D</creator><creatorcontrib>Thadhani, Ravi ; Appelbaum, Evan ; Pritchett, Yili ; Chang, Yuchiao ; Wenger, Julia ; Tamez, Hector ; Bhan, Ishir ; Agarwal, Rajiv ; Zoccali, Carmine ; Wanner, Christoph ; Lloyd-Jones, Donald ; Cannata, Jorge ; Thompson, B. Taylor ; Andress, Dennis ; Zhang, Wuyan ; Packham, David ; Singh, Bhupinder ; Zehnder, Daniel ; Shah, Amil ; Pachika, Ajay ; Manning, Warren J ; Solomon, Scott D</creatorcontrib><description>CONTEXT Vitamin D is associated with decreased cardiovascular-related morbidity and mortality, possibly by modifying cardiac structure and function, yet firm evidence for either remains lacking. OBJECTIVE To determine the effects of an active vitamin D compound, paricalcitol, on left ventricular mass over 48 weeks in patients with an estimated glomerular filtration rate of 15 to 60 mL/min/1.73 m2. DESIGN, SETTING, AND PARTICIPANTS Multinational, double-blind, randomized placebo-controlled trial among 227 patients with chronic kidney disease, mild to moderate left ventricular hypertrophy, and preserved left ventricular ejection fraction, conducted in 11 countries from July 2008 through September 2010. INTERVENTION Participants were randomly assigned to receive oral paricalcitol, 2 μg/d (n =115), or matching placebo (n = 112). MAIN OUTCOME MEASURES Change in left ventricular mass index over 48 weeks by cardiovascular magnetic resonance imaging. Secondary end points included echocardiographic changes in left ventricular diastolic function. RESULTS Treatment with paricalcitol reduced parathyroid hormone levels within 4 weeks and maintained levels within the normal range throughout the study duration. At 48 weeks, the change in left ventricular mass index did not differ between treatment groups (paricalcitol group, 0.34 g/m2.7 [95% CI, −0.14 to 0.83 g/m2.7] vs placebo group, −0.07 g/m2.7 [95% CI, −0.55 to 0.42 g/m2.7]). Doppler measures of diastolic function including peak early diastolic lateral mitral annular tissue velocity (paricalcitol group, −0.01 cm/s [95% CI, −0.63 to 0.60 cm/s] vs placebo group, −0.30 cm/s [95% CI, −0.93 to 0.34 cm/s]) also did not differ. Episodes of hypercalcemia were more frequent in the paricalcitol group compared with the placebo group. CONCLUSION Forty-eight week therapy with paricalcitol did not alter left ventricular mass index or improve certain measures of diastolic dysfunction in patients with chronic kidney disease. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00497146</description><identifier>ISSN: 0098-7484</identifier><identifier>EISSN: 1538-3598</identifier><identifier>DOI: 10.1001/jama.2012.120</identifier><identifier>PMID: 22337679</identifier><identifier>CODEN: JAMAAP</identifier><language>eng</language><publisher>Chicago, IL: American Medical Association</publisher><subject>Aged ; Biological and medical sciences ; Chronic Disease ; Clinical trials ; Double-Blind Method ; Drug therapy ; Ergocalciferols - pharmacology ; Ergocalciferols - therapeutic use ; Female ; General aspects ; Glomerular Filtration Rate ; Humans ; Hypercalcemia - chemically induced ; Hyperparathyroidism, Secondary - drug therapy ; Hypertrophy, Left Ventricular - drug therapy ; Hypertrophy, Left Ventricular - etiology ; Kidney diseases ; Kidney Diseases - complications ; Kidneys ; Male ; Medical sciences ; Middle Aged ; Nephrology. Urinary tract diseases ; Nephropathies. Renovascular diseases. Renal failure ; Parathyroid Hormone - blood ; Patients ; Renal failure ; Treatment Outcome ; Urinary system involvement in other diseases. Miscellaneous ; Ventricular Function, Left - drug effects ; Vitamin D ; Vitamin D Deficiency - complications ; Vitamin D Deficiency - drug therapy ; Vitamin D Deficiency - etiology ; Vitamins - pharmacology ; Vitamins - therapeutic use</subject><ispartof>JAMA : the journal of the American Medical Association, 2012-02, Vol.307 (7), p.674-684</ispartof><rights>2015 INIST-CNRS</rights><rights>Copyright American Medical Association Feb 15, 2012</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></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.2012.120$$EPDF$$P50$$Gama$$H</linktopdf><linktohtml>$$Uhttps://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2012.120$$EHTML$$P50$$Gama$$H</linktohtml><link.rule.ids>64,314,776,780,3326,27903,27904,76235,76238</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=25571161$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22337679$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Thadhani, Ravi</creatorcontrib><creatorcontrib>Appelbaum, Evan</creatorcontrib><creatorcontrib>Pritchett, Yili</creatorcontrib><creatorcontrib>Chang, Yuchiao</creatorcontrib><creatorcontrib>Wenger, Julia</creatorcontrib><creatorcontrib>Tamez, Hector</creatorcontrib><creatorcontrib>Bhan, Ishir</creatorcontrib><creatorcontrib>Agarwal, Rajiv</creatorcontrib><creatorcontrib>Zoccali, Carmine</creatorcontrib><creatorcontrib>Wanner, Christoph</creatorcontrib><creatorcontrib>Lloyd-Jones, Donald</creatorcontrib><creatorcontrib>Cannata, Jorge</creatorcontrib><creatorcontrib>Thompson, B. Taylor</creatorcontrib><creatorcontrib>Andress, Dennis</creatorcontrib><creatorcontrib>Zhang, Wuyan</creatorcontrib><creatorcontrib>Packham, David</creatorcontrib><creatorcontrib>Singh, Bhupinder</creatorcontrib><creatorcontrib>Zehnder, Daniel</creatorcontrib><creatorcontrib>Shah, Amil</creatorcontrib><creatorcontrib>Pachika, Ajay</creatorcontrib><creatorcontrib>Manning, Warren J</creatorcontrib><creatorcontrib>Solomon, Scott D</creatorcontrib><title>Vitamin D Therapy and Cardiac Structure and Function in Patients With Chronic Kidney Disease: The PRIMO Randomized Controlled Trial</title><title>JAMA : the journal of the American Medical Association</title><addtitle>JAMA</addtitle><description>CONTEXT Vitamin D is associated with decreased cardiovascular-related morbidity and mortality, possibly by modifying cardiac structure and function, yet firm evidence for either remains lacking. OBJECTIVE To determine the effects of an active vitamin D compound, paricalcitol, on left ventricular mass over 48 weeks in patients with an estimated glomerular filtration rate of 15 to 60 mL/min/1.73 m2. DESIGN, SETTING, AND PARTICIPANTS Multinational, double-blind, randomized placebo-controlled trial among 227 patients with chronic kidney disease, mild to moderate left ventricular hypertrophy, and preserved left ventricular ejection fraction, conducted in 11 countries from July 2008 through September 2010. INTERVENTION Participants were randomly assigned to receive oral paricalcitol, 2 μg/d (n =115), or matching placebo (n = 112). MAIN OUTCOME MEASURES Change in left ventricular mass index over 48 weeks by cardiovascular magnetic resonance imaging. Secondary end points included echocardiographic changes in left ventricular diastolic function. RESULTS Treatment with paricalcitol reduced parathyroid hormone levels within 4 weeks and maintained levels within the normal range throughout the study duration. At 48 weeks, the change in left ventricular mass index did not differ between treatment groups (paricalcitol group, 0.34 g/m2.7 [95% CI, −0.14 to 0.83 g/m2.7] vs placebo group, −0.07 g/m2.7 [95% CI, −0.55 to 0.42 g/m2.7]). Doppler measures of diastolic function including peak early diastolic lateral mitral annular tissue velocity (paricalcitol group, −0.01 cm/s [95% CI, −0.63 to 0.60 cm/s] vs placebo group, −0.30 cm/s [95% CI, −0.93 to 0.34 cm/s]) also did not differ. Episodes of hypercalcemia were more frequent in the paricalcitol group compared with the placebo group. CONCLUSION Forty-eight week therapy with paricalcitol did not alter left ventricular mass index or improve certain measures of diastolic dysfunction in patients with chronic kidney disease. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00497146</description><subject>Aged</subject><subject>Biological and medical sciences</subject><subject>Chronic Disease</subject><subject>Clinical trials</subject><subject>Double-Blind Method</subject><subject>Drug therapy</subject><subject>Ergocalciferols - pharmacology</subject><subject>Ergocalciferols - therapeutic use</subject><subject>Female</subject><subject>General aspects</subject><subject>Glomerular Filtration Rate</subject><subject>Humans</subject><subject>Hypercalcemia - chemically induced</subject><subject>Hyperparathyroidism, Secondary - drug therapy</subject><subject>Hypertrophy, Left Ventricular - drug therapy</subject><subject>Hypertrophy, Left Ventricular - etiology</subject><subject>Kidney diseases</subject><subject>Kidney Diseases - complications</subject><subject>Kidneys</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Nephrology. Urinary tract diseases</subject><subject>Nephropathies. Renovascular diseases. Renal failure</subject><subject>Parathyroid Hormone - blood</subject><subject>Patients</subject><subject>Renal failure</subject><subject>Treatment Outcome</subject><subject>Urinary system involvement in other diseases. Miscellaneous</subject><subject>Ventricular Function, Left - drug effects</subject><subject>Vitamin D</subject><subject>Vitamin D Deficiency - complications</subject><subject>Vitamin D Deficiency - drug therapy</subject><subject>Vitamin D Deficiency - etiology</subject><subject>Vitamins - pharmacology</subject><subject>Vitamins - therapeutic use</subject><issn>0098-7484</issn><issn>1538-3598</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp90c1v0zAYx3ELgVgZHLlwQBYSgkuKX5LY2Q117EUMbRoFjtHT5LHqKnGK7RzKlX8cZ-2GxIFcElkffSPrR8hLzuacMf5hAz3MBeNizgV7RGa8kDqTRaUfkxljlc5UrvMj8iyEDUsPl-opORJCSlWqakZ-f7cReuvoKV2u0cN2R8G1dAG-tdDQr9GPTRw93p2eja6JdnA0-RuIFl0M9IeNa7pY-8HZhn62rcMdPbUBIeDJ1KQ3t5dfrultCgy9_YUpPrjoh65Ln0tvoXtOnhjoAr44vI_Jt7NPy8VFdnV9frn4eJWBLFTMClRtyWS6n-CyLFaochRgwBR5ZXIpG1y1vELIlTKKIQMj87IyUkELbWlaeUze7btbP_wcMcS6t6HBrgOHwxjqSgjBFdMqyff_lVxLleJaF4m--YduhtG7dI_UU0rykk0o26PGDyF4NPXW2x78ruasnmaspxnracY6zZj860N0XPXYPuj73RJ4ewAQGuiMB9fY8NcVheK85Mm92rsp__BPzvJK5_IPhUCtUQ</recordid><startdate>20120215</startdate><enddate>20120215</enddate><creator>Thadhani, Ravi</creator><creator>Appelbaum, Evan</creator><creator>Pritchett, Yili</creator><creator>Chang, Yuchiao</creator><creator>Wenger, Julia</creator><creator>Tamez, Hector</creator><creator>Bhan, Ishir</creator><creator>Agarwal, Rajiv</creator><creator>Zoccali, Carmine</creator><creator>Wanner, Christoph</creator><creator>Lloyd-Jones, Donald</creator><creator>Cannata, Jorge</creator><creator>Thompson, B. Taylor</creator><creator>Andress, Dennis</creator><creator>Zhang, Wuyan</creator><creator>Packham, David</creator><creator>Singh, Bhupinder</creator><creator>Zehnder, Daniel</creator><creator>Shah, Amil</creator><creator>Pachika, Ajay</creator><creator>Manning, Warren J</creator><creator>Solomon, Scott D</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>AAYXX</scope><scope>CITATION</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><scope>7X8</scope></search><sort><creationdate>20120215</creationdate><title>Vitamin D Therapy and Cardiac Structure and Function in Patients With Chronic Kidney Disease: The PRIMO Randomized Controlled Trial</title><author>Thadhani, Ravi ; Appelbaum, Evan ; Pritchett, Yili ; Chang, Yuchiao ; Wenger, Julia ; Tamez, Hector ; Bhan, Ishir ; Agarwal, Rajiv ; Zoccali, Carmine ; Wanner, Christoph ; Lloyd-Jones, Donald ; Cannata, Jorge ; Thompson, B. Taylor ; Andress, Dennis ; Zhang, Wuyan ; Packham, David ; Singh, Bhupinder ; Zehnder, Daniel ; Shah, Amil ; Pachika, Ajay ; Manning, Warren J ; Solomon, Scott D</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-a357t-5e7d60353821365be74e2afaf549f433cebd19ea477f70e0af3469f37adad6fd3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Aged</topic><topic>Biological and medical sciences</topic><topic>Chronic Disease</topic><topic>Clinical trials</topic><topic>Double-Blind Method</topic><topic>Drug therapy</topic><topic>Ergocalciferols - pharmacology</topic><topic>Ergocalciferols - therapeutic use</topic><topic>Female</topic><topic>General aspects</topic><topic>Glomerular Filtration Rate</topic><topic>Humans</topic><topic>Hypercalcemia - chemically induced</topic><topic>Hyperparathyroidism, Secondary - drug therapy</topic><topic>Hypertrophy, Left Ventricular - drug therapy</topic><topic>Hypertrophy, Left Ventricular - etiology</topic><topic>Kidney diseases</topic><topic>Kidney Diseases - complications</topic><topic>Kidneys</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Nephrology. Urinary tract diseases</topic><topic>Nephropathies. Renovascular diseases. Renal failure</topic><topic>Parathyroid Hormone - blood</topic><topic>Patients</topic><topic>Renal failure</topic><topic>Treatment Outcome</topic><topic>Urinary system involvement in other diseases. Miscellaneous</topic><topic>Ventricular Function, Left - drug effects</topic><topic>Vitamin D</topic><topic>Vitamin D Deficiency - complications</topic><topic>Vitamin D Deficiency - drug therapy</topic><topic>Vitamin D Deficiency - etiology</topic><topic>Vitamins - pharmacology</topic><topic>Vitamins - therapeutic use</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Thadhani, Ravi</creatorcontrib><creatorcontrib>Appelbaum, Evan</creatorcontrib><creatorcontrib>Pritchett, Yili</creatorcontrib><creatorcontrib>Chang, Yuchiao</creatorcontrib><creatorcontrib>Wenger, Julia</creatorcontrib><creatorcontrib>Tamez, Hector</creatorcontrib><creatorcontrib>Bhan, Ishir</creatorcontrib><creatorcontrib>Agarwal, Rajiv</creatorcontrib><creatorcontrib>Zoccali, Carmine</creatorcontrib><creatorcontrib>Wanner, Christoph</creatorcontrib><creatorcontrib>Lloyd-Jones, Donald</creatorcontrib><creatorcontrib>Cannata, Jorge</creatorcontrib><creatorcontrib>Thompson, B. Taylor</creatorcontrib><creatorcontrib>Andress, Dennis</creatorcontrib><creatorcontrib>Zhang, Wuyan</creatorcontrib><creatorcontrib>Packham, David</creatorcontrib><creatorcontrib>Singh, Bhupinder</creatorcontrib><creatorcontrib>Zehnder, Daniel</creatorcontrib><creatorcontrib>Shah, Amil</creatorcontrib><creatorcontrib>Pachika, Ajay</creatorcontrib><creatorcontrib>Manning, Warren J</creatorcontrib><creatorcontrib>Solomon, Scott D</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>CrossRef</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><collection>MEDLINE - Academic</collection><jtitle>JAMA : the journal of the American Medical Association</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Thadhani, Ravi</au><au>Appelbaum, Evan</au><au>Pritchett, Yili</au><au>Chang, Yuchiao</au><au>Wenger, Julia</au><au>Tamez, Hector</au><au>Bhan, Ishir</au><au>Agarwal, Rajiv</au><au>Zoccali, Carmine</au><au>Wanner, Christoph</au><au>Lloyd-Jones, Donald</au><au>Cannata, Jorge</au><au>Thompson, B. Taylor</au><au>Andress, Dennis</au><au>Zhang, Wuyan</au><au>Packham, David</au><au>Singh, Bhupinder</au><au>Zehnder, Daniel</au><au>Shah, Amil</au><au>Pachika, Ajay</au><au>Manning, Warren J</au><au>Solomon, Scott D</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Vitamin D Therapy and Cardiac Structure and Function in Patients With Chronic Kidney Disease: The PRIMO Randomized Controlled Trial</atitle><jtitle>JAMA : the journal of the American Medical Association</jtitle><addtitle>JAMA</addtitle><date>2012-02-15</date><risdate>2012</risdate><volume>307</volume><issue>7</issue><spage>674</spage><epage>684</epage><pages>674-684</pages><issn>0098-7484</issn><eissn>1538-3598</eissn><coden>JAMAAP</coden><abstract>CONTEXT Vitamin D is associated with decreased cardiovascular-related morbidity and mortality, possibly by modifying cardiac structure and function, yet firm evidence for either remains lacking. OBJECTIVE To determine the effects of an active vitamin D compound, paricalcitol, on left ventricular mass over 48 weeks in patients with an estimated glomerular filtration rate of 15 to 60 mL/min/1.73 m2. DESIGN, SETTING, AND PARTICIPANTS Multinational, double-blind, randomized placebo-controlled trial among 227 patients with chronic kidney disease, mild to moderate left ventricular hypertrophy, and preserved left ventricular ejection fraction, conducted in 11 countries from July 2008 through September 2010. INTERVENTION Participants were randomly assigned to receive oral paricalcitol, 2 μg/d (n =115), or matching placebo (n = 112). MAIN OUTCOME MEASURES Change in left ventricular mass index over 48 weeks by cardiovascular magnetic resonance imaging. Secondary end points included echocardiographic changes in left ventricular diastolic function. RESULTS Treatment with paricalcitol reduced parathyroid hormone levels within 4 weeks and maintained levels within the normal range throughout the study duration. At 48 weeks, the change in left ventricular mass index did not differ between treatment groups (paricalcitol group, 0.34 g/m2.7 [95% CI, −0.14 to 0.83 g/m2.7] vs placebo group, −0.07 g/m2.7 [95% CI, −0.55 to 0.42 g/m2.7]). Doppler measures of diastolic function including peak early diastolic lateral mitral annular tissue velocity (paricalcitol group, −0.01 cm/s [95% CI, −0.63 to 0.60 cm/s] vs placebo group, −0.30 cm/s [95% CI, −0.93 to 0.34 cm/s]) also did not differ. Episodes of hypercalcemia were more frequent in the paricalcitol group compared with the placebo group. CONCLUSION Forty-eight week therapy with paricalcitol did not alter left ventricular mass index or improve certain measures of diastolic dysfunction in patients with chronic kidney disease. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00497146</abstract><cop>Chicago, IL</cop><pub>American Medical Association</pub><pmid>22337679</pmid><doi>10.1001/jama.2012.120</doi><tpages>11</tpages></addata></record> |
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subjects | Aged Biological and medical sciences Chronic Disease Clinical trials Double-Blind Method Drug therapy Ergocalciferols - pharmacology Ergocalciferols - therapeutic use Female General aspects Glomerular Filtration Rate Humans Hypercalcemia - chemically induced Hyperparathyroidism, Secondary - drug therapy Hypertrophy, Left Ventricular - drug therapy Hypertrophy, Left Ventricular - etiology Kidney diseases Kidney Diseases - complications Kidneys Male Medical sciences Middle Aged Nephrology. Urinary tract diseases Nephropathies. Renovascular diseases. Renal failure Parathyroid Hormone - blood Patients Renal failure Treatment Outcome Urinary system involvement in other diseases. Miscellaneous Ventricular Function, Left - drug effects Vitamin D Vitamin D Deficiency - complications Vitamin D Deficiency - drug therapy Vitamin D Deficiency - etiology Vitamins - pharmacology Vitamins - therapeutic use |
title | Vitamin D Therapy and Cardiac Structure and Function in Patients With Chronic Kidney Disease: The PRIMO Randomized Controlled Trial |
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