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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