Impact of Parathyroidectomy on Cardiovascular Calcification in Dialysis-dependent Patients

Completed

• Conditions: Chronic Kidney Disease Mineral and Bone Disorder; Dialysis; Secondary Hyperparathyroidism; Vascular Calcification

• Registration Number: NCT03937349
• Lead Sponsor: Saint Petersburg State University, Russia

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-01
• Study First Submitted QC: 2019-05-02
• Study First Posted: 2019-05-03
• Study Start: 2019-05-14
• Primary Completion: 2024-01-18
• Study Completion: 2024-01-18
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in vascular calcification score measured with semi-quantitative (Kauppila) test	18 months
Change in coronary artery calcium score measured with CT	18 months

Secondary Outcome Measures

Name	Time	Method
Change in alkaline phosphatase	18 months
Change in intact parathyroid hormone (iPTH) level	18 months
Change in serum calcium level	18 months
Change in heart valve calcium score	18 months
Serious adverse events (cardiovascular events, death, fractures, emergency hospital admissions) during the follow-up period	18 months
Change in serum phosphate level	18weeks

Trial Locations

Locations (1)

Saint-Petersburg State University, Clinic of advanced medical technologies n.a. N.I.Pirogov; 🇷🇺 Saint Petersburg, Russian Federation