TY - JOUR
T1 - Effect of active vitamin-D on left ventricular mass index
T2 - Results of a randomized controlled trial in type 2 diabetes and chronic kidney disease
AU - Gnudi, Luigi
AU - Fountoulakis, Nikolaos
AU - Panagiotou, Angeliki
AU - Corcillo, Antonella
AU - Maltese, Giuseppe
AU - Rife, Maria Flaquer
AU - Ntalas, Ioannis
AU - Franks, Russell
AU - Chiribiri, Amedeo
AU - Ayis, Salma
AU - Karalliedde, Janaka
N1 - Funding Information:
We acknowledge support from National Institute for Health and Research, Biomedical Research Centre award to Guy...s and St Thomas Foundation Trust in partnership with King...s College London. Collected data is available on request.
Funding Information:
This work (EudraCT number 2011-003025-10) was supported by a research grant from the European Foundation for the Study of Diabetes (EFSD). EFSD was not involved in the conduct of the study. The authors are solely responsible for the design and conduct of this study, statistical study analyses, drafting and editing of the paper, and its final contents.
Funding Information:
We acknowledge support from National Institute for Health and Research, Biomedical Research Centre award to Guy…s and St Thomas Foundation Trust in partnership with King…s College London. Collected data is available on request. We also acknowledge Professor Martin Gulliford (King's College London, UK) for helpful discussion. We are grateful to the patients who participated in this research. This work was presented, in abstract form, at the 58th annual meeting of the European Association for the Study of Diabetes.
Publisher Copyright:
© 2023 The Author(s)
PY - 2023/7
Y1 - 2023/7
N2 - Background: Active vitamin-D deficiency is a potential modifiable risk factor for increased ventricular mass. We explored the effects of active vitamin-D (calcitriol) treatment on left ventricular mass in patients with type-2 diabetes (T2D) and chronic kidney disease (CKD). Methods: We performed a 48-week duration single center randomized double-blind parallel group trial examining the impact of calcitriol, 0.5 mcg once daily, as compared to placebo on a primary endpoint of change from baseline in left ventricular mass index (LVMI) measured by magnetic resonance imaging. Patients with T2D, CKD stage-3 and raised left ventricular mass on stable renin angiotensin aldosterone system blockade, who all had elevated intact parathyroid hormone were eligible. Secondary endpoints included interstitial myocardial fibrosis, assessed with cardiac magnetic resonance imaging. In total, 45 (male 73%) patients with T2D and stage-3 CKD were studied (calcitriol n = 19, placebo n = 26). Results: Following 48-weeks calcitriol treatment, the median difference and the (95% CI) of LVMI between the 2 treatment arms was 1.84 (-1.28, 4.96), similar between the 2 groups studied. Intact parathyroid hormone fell only in the calcitriol group from 142 pg/mL (80–293) to 76 pg/mL (41–204)(median, interquartile range, P= .04). No significant differences were observed in interstitial myocardial fibrosis or other secondary endpoints. Conclusions: The study did not provide evidence that treatment with calcitriol as compared to placebo might improve LVMI in patients with T2D, mild left ventricular hypertrophy and stable CKD. Our data does not support the routine use of active vitamin-D for LVMI regression and cardiovascular protection in patients with T2D and stage-3 CKD.
AB - Background: Active vitamin-D deficiency is a potential modifiable risk factor for increased ventricular mass. We explored the effects of active vitamin-D (calcitriol) treatment on left ventricular mass in patients with type-2 diabetes (T2D) and chronic kidney disease (CKD). Methods: We performed a 48-week duration single center randomized double-blind parallel group trial examining the impact of calcitriol, 0.5 mcg once daily, as compared to placebo on a primary endpoint of change from baseline in left ventricular mass index (LVMI) measured by magnetic resonance imaging. Patients with T2D, CKD stage-3 and raised left ventricular mass on stable renin angiotensin aldosterone system blockade, who all had elevated intact parathyroid hormone were eligible. Secondary endpoints included interstitial myocardial fibrosis, assessed with cardiac magnetic resonance imaging. In total, 45 (male 73%) patients with T2D and stage-3 CKD were studied (calcitriol n = 19, placebo n = 26). Results: Following 48-weeks calcitriol treatment, the median difference and the (95% CI) of LVMI between the 2 treatment arms was 1.84 (-1.28, 4.96), similar between the 2 groups studied. Intact parathyroid hormone fell only in the calcitriol group from 142 pg/mL (80–293) to 76 pg/mL (41–204)(median, interquartile range, P= .04). No significant differences were observed in interstitial myocardial fibrosis or other secondary endpoints. Conclusions: The study did not provide evidence that treatment with calcitriol as compared to placebo might improve LVMI in patients with T2D, mild left ventricular hypertrophy and stable CKD. Our data does not support the routine use of active vitamin-D for LVMI regression and cardiovascular protection in patients with T2D and stage-3 CKD.
UR - http://www.scopus.com/inward/record.url?scp=85151696515&partnerID=8YFLogxK
U2 - 10.1016/j.ahj.2023.03.003
DO - 10.1016/j.ahj.2023.03.003
M3 - Article
SN - 0002-8703
VL - 261
SP - 1
EP - 9
JO - American Heart Journal
JF - American Heart Journal
ER -