Impact of Parathyroidectomy on Cardiovascular Calcification in Dialysis-dependent Patients

• Sponsor: Saint Petersburg State University, Russia (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03937349
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Anticipated Duration (Months): 54.6
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Secondary Hyperparathyroidism; Chronic Kidney Disease Mineral and Bone Disorder; Vascular Calcification; Dialysis

Study Design

• Study Type: Observational
• Anticipated Enrollment: 60 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Impact of Parathyroidectomy on Cardiovascular Calcification in Dialysis-dependent Patients: a Prospective Cohort Study
• Actual Study Start Date: May 14, 2019
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
sPTx group Patients underwent subtotal parathyroidectomy due to severe secondary hyperparathyroidism
TPTx+AT group Patients underwent total parathyroidectomy with immediate autotransplantation of parathyroid tissue due to severe secondary hyperparathyroidism
Control group Patients with severe SHPT on conservative treatment (calcimimetics, active vitamin D analogues, phosphate-binders) who are likely to undergo surgery in a period of 12 months

Outcome Measures

Primary Outcome Measures

1. Change in coronary artery calcium score measured with CT [18 months]

2. Change in vascular calcification score measured with semi-quantitative (Kauppila) test [18 months]

Secondary Outcome Measures

1. Change in heart valve calcium score [18 months]

2. Change in intact parathyroid hormone (iPTH) level [18 months]

3. Change in serum calcium level [18 months]

4. Change in serum phosphate level [18weeks]

5. Change in alkaline phosphatase [18 months]

6. Serious adverse events (cardiovascular events, death, fractures, emergency hospital admissions) during the follow-up period [18 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Saint-Petersburg State University, Clinic of advanced medical technologies n.a. N.I.Pirogov	Saint Petersburg		Russian Federation	190103

Sponsors and Collaborators

• Saint Petersburg State University, Russia

Investigators

• Principal Investigator: Ekaterina Parshina, MD, Saint Petersburg State University, Russia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ekaterina Parshina, Principal investigator, Saint Petersburg State University, Russia
• ClinicalTrials.gov Identifier: NCT03937349
• Other Study ID Numbers: Calcification
• First Posted: May 3, 2019
• Last Update Posted: May 5, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Bone Diseases; Chronic Kidney Disease-Mineral and Bone Disorder; Kidney Diseases; Renal Insufficiency, Chronic; Calcinosis; Vascular Calcification; Hyperparathyroidism; Hyperparathyroidism, Secondary

Study Results

No Results Posted as of May 5, 2022