Vitamin D therapy and cardiac structure and function in patients with chronic kidney disease

The PRIMO randomized controlled trial

Ravi Thadhani, Evan Appelbaum, Yili Pritchett, Yuchiao Chang, Julia Wenger, Hector Tamez, Ishir Bhan, Rajiv Agarwal, Carmine Zoccali, Christoph Wanner, Donald Lloyd-Jones, Jorge Cannata, B. Taylor Thompson, Dennis Andress, Wuyan Zhang, David Packham, Bhupinder Singh, Daniel Zehnder, Amil Shah, Ajay Pachika & 2 others Warren J. Manning, Scott D. Solomon

Research output: Contribution to journalArticle

330 Citations (Scopus)

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 m 2. 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/m 2.7 [95% CI, -0.14 to 0.83 g/m 2.7] vs placebo group, -0.07 g/m 2.7 [95% CI, -0.55 to 0.42 g/m 2.7]). 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

Original languageEnglish
Pages (from-to)674-684
Number of pages11
JournalJournal of the American Medical Association
Volume307
Issue number7
DOIs
StatePublished - Feb 15 2012

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Chronic Renal Insufficiency
Vitamin D
Randomized Controlled Trials
Placebos
Therapeutics
Hypercalcemia
Left Ventricular Hypertrophy
paricalcitol
Parathyroid Hormone
Glomerular Filtration Rate
Left Ventricular Function
Stroke Volume
Reference Values
Magnetic Resonance Imaging
Outcome Assessment (Health Care)
Morbidity
Mortality

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Vitamin D therapy and cardiac structure and function in patients with chronic kidney disease : The PRIMO randomized controlled trial. / 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.

In: Journal of the American Medical Association, Vol. 307, No. 7, 15.02.2012, p. 674-684.

Research output: Contribution to journalArticle

Thadhani, R, Appelbaum, E, Pritchett, Y, Chang, Y, Wenger, J, Tamez, H, Bhan, I, Agarwal, R, Zoccali, C, Wanner, C, Lloyd-Jones, D, Cannata, J, Thompson, BT, Andress, D, Zhang, W, Packham, D, Singh, B, Zehnder, D, Shah, A, Pachika, A, Manning, WJ & Solomon, SD 2012, 'Vitamin D therapy and cardiac structure and function in patients with chronic kidney disease: The PRIMO randomized controlled trial', Journal of the American Medical Association, vol. 307, no. 7, pp. 674-684. https://doi.org/10.1001/jama.2012.120
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. / Vitamin D therapy and cardiac structure and function in patients with chronic kidney disease : The PRIMO randomized controlled trial. In: Journal of the American Medical Association. 2012 ; Vol. 307, No. 7. pp. 674-684.
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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 m 2. 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/m 2.7 [95{\%} CI, -0.14 to 0.83 g/m 2.7] vs placebo group, -0.07 g/m 2.7 [95{\%} CI, -0.55 to 0.42 g/m 2.7]). 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",
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AU - Thadhani, Ravi

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AU - Pritchett, Yili

AU - Chang, Yuchiao

AU - Wenger, Julia

AU - Tamez, Hector

AU - Bhan, Ishir

AU - Agarwal, Rajiv

AU - Zoccali, Carmine

AU - Wanner, Christoph

AU - Lloyd-Jones, Donald

AU - Cannata, Jorge

AU - Thompson, B. Taylor

AU - Andress, Dennis

AU - Zhang, Wuyan

AU - Packham, David

AU - Singh, Bhupinder

AU - Zehnder, Daniel

AU - Shah, Amil

AU - Pachika, Ajay

AU - Manning, Warren J.

AU - Solomon, Scott D.

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N2 - 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 m 2. 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/m 2.7 [95% CI, -0.14 to 0.83 g/m 2.7] vs placebo group, -0.07 g/m 2.7 [95% CI, -0.55 to 0.42 g/m 2.7]). 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

AB - 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 m 2. 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/m 2.7 [95% CI, -0.14 to 0.83 g/m 2.7] vs placebo group, -0.07 g/m 2.7 [95% CI, -0.55 to 0.42 g/m 2.7]). 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

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