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Updated: May 10, 2026
Assessment of Vascular Function in Patients With Chronic Kidney Disease
Published on: June 16, 2014
Vitamin D therapy and cardiac structure and function in patients with chronic kidney disease: the PRIMO randomized
Ravi Thadhani1, Evan Appelbaum, Yili Pritchett
1Division of Nephrology, Massachusetts General Hospital, 55 Fruit St, Boston, MA 02114, USA. thadhani.r@mgh.harvard.edu
Insights
Active vitamin D compound, paricalcitol, did not reduce left ventricular mass in patients with chronic kidney disease over 48 weeks. This study also found no improvements in diastolic dysfunction, with increased hypercalcemia risk.
Area of Science:
- Nephrology
- Cardiology
- Endocrinology
Background:
- Vitamin D's potential role in cardiovascular health is suggested but lacks robust evidence.
- Chronic kidney disease (CKD) patients often have cardiovascular complications.
- Left ventricular hypertrophy (LVH) is common in CKD and linked to poor outcomes.
Purpose of the Study:
- To investigate the effect of paricalcitol on left ventricular mass in CKD patients.
- To assess paricalcitol's impact on diastolic function in this population.
- To evaluate safety, including hypercalcemia risk.
Main Methods:
- A multinational, double-blind, randomized placebo-controlled trial involving 227 CKD patients.
- Participants received either oral paricalcitol (2 μg/d) or a placebo for 48 weeks.
- Left ventricular mass index was measured using cardiovascular magnetic resonance imaging; diastolic function was assessed via echocardiography.
Main Results:
- Paricalcitol effectively reduced parathyroid hormone levels but did not significantly alter left ventricular mass index compared to placebo.
- No significant differences were observed in Doppler measures of diastolic function between the groups.
- Hypercalcemia episodes were more frequent in the paricalcitol group.
Conclusions:
- Forty-eight weeks of paricalcitol therapy did not change left ventricular mass index in CKD patients.
- Paricalcitol did not improve diastolic dysfunction measures in this study population.
- The findings suggest limited benefit of paricalcitol for cardiac remodeling in CKD, with a noted increase in hypercalcemia risk.
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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