Secondary Hyperparathyroidism Clinical Trial
Official title:
Impact of Parathyroidectomy on Cardiovascular Calcification in Dialysis-dependent Patients: a Prospective Cohort Study
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 |
Verified date | April 2024 |
Source | Saint Petersburg State University, Russia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Saint-Petersburg State University, Clinic of advanced medical technologies n.a. N.I.Pirogov | Saint Petersburg |
Lead Sponsor | Collaborator |
---|---|
Saint Petersburg State University, Russia |
Russian Federation,
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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