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NCT03937349 Clinical Trial

Impact of Parathyroidectomy on Cardiovascular Calcification in Dialysis-dependent Patients

Secondary Hyperparathyroidism Clinical Trial

Official title:
Impact of Parathyroidectomy on Cardiovascular Calcification in Dialysis-dependent Patients: a Prospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03937349
Other study ID # Calcification
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 14, 2019
Est. completion date January 18, 2024

Study information
Verified date April 2024
Source Saint Petersburg State University, Russia
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 63
Est. completion date January 18, 2024
Est. primary completion date January 18, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Russian Federation Saint-Petersburg State University, Clinic of advanced medical technologies n.a. N.I.Pirogov Saint Petersburg

Sponsors (1)
Lead Sponsor Collaborator
Saint Petersburg State University, Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in coronary artery calcium score measured with CT 18 months
Primary Change in vascular calcification score measured with semi-quantitative (Kauppila) test 18 months
Secondary Change in heart valve calcium score 18 months
Secondary Change in intact parathyroid hormone (iPTH) level 18 months
Secondary Change in serum calcium level 18 months
Secondary Change in serum phosphate level 18weeks
Secondary Change in alkaline phosphatase 18 months
Secondary Serious adverse events (cardiovascular events, death, fractures, emergency hospital admissions) during the follow-up period 18 months
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