Impact of Parathyroidectomy on Cardiovascular Calcification in Dialysis-dependent Patients

Saint Petersburg State University, Russia63 enrolled

Overview

This is a prospective cohort study aimed to evaluate change of cardiovascular calcification after parathyroidectomy in patients with end-stage renal disease on dialysis compared with control group on conservative treatment.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Secondary Hyperparathyroidism Chronic Kidney Disease Mineral and Bone Disorder Vascular Calcification Dialysis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age \> 18 years 2. ESRD patients receiving long-term hemodialysis or peritoneal dialysis treatment 3. Severe secondary hyperparathyroidism defined as iPTH level \> 800 pg/ml, followed with hypercalcemia and/or hyperphosphatemia; with presence of one or more nodular or diffuse parathyroid hyperplasia confirmed with CT Exclusion Criteria: 1\. Primary hyperparathyroidosis as a cause of ESRD

Locations (1)

Saint-Petersburg State University, Clinic of advanced medical technologies n.a. N.I.Pirogov

Saint Petersburg, Russia

Outcomes

Primary Outcomes

Change in coronary artery calcium score measured with CT

Time frame: 18 months

Change in vascular calcification score measured with semi-quantitative (Kauppila) test

Time frame: 18 months

Secondary Outcomes

Change in heart valve calcium score

Time frame: 18 months

Change in intact parathyroid hormone (iPTH) level

Time frame: 18 months

Change in serum calcium level

Time frame: 18 months

Change in serum phosphate level

Time frame: 18weeks

Change in alkaline phosphatase

Time frame: 18 months

Serious adverse events (cardiovascular events, death, fractures, emergency hospital admissions) during the follow-up period

Time frame: 18 months

Data from ClinicalTrials.gov

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