Impact of Parathyroidectomy on Cardiovascular Calcification in Dialysis-dependent Patients

NCT03937349 | Completed

• 1 other identifier: Calcification
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Change in coronary artery calcium score measured with CT

  18 months

• Change in vascular calcification score measured with semi-quantitative (Kauppila) test

  18 months

Secondary Outcomes (6)

• Change in heart valve calcium score

  18 months

• Change in intact parathyroid hormone (iPTH) level

  18 months

• Change in serum calcium level

  18 months

• Change in serum phosphate level

  18weeks

• Change in alkaline phosphatase

  18 months

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients receiving long-term dialysis treatment, met the criteria for parathyroidectomy due to severe SHPT

You may qualify if:

• Age \> 18 years
• ESRD patients receiving long-term hemodialysis or peritoneal dialysis treatment
• 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

You may not qualify if:

• \. Primary hyperparathyroidosis as a cause of ESRD

Sponsors & Collaborators

• Saint Petersburg State University, Russia: lead

Study Sites (1)

Saint-Petersburg State University, Clinic of advanced medical technologies n.a. N.I.Pirogov

Saint Petersburg, 190103, Russia

Location

MeSH Terms

Conditions

Hyperparathyroidism, Secondary; Chronic Kidney Disease-Mineral and Bone Disorder; Vascular Calcification

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Rickets; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Calcium Metabolism Disorders; Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Calcinosis

Study Officials

• Ekaterina Parshina, MD

  Saint Petersburg State University, Russia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 1, 2019
• First Posted: May 3, 2019
• Study Start: May 14, 2019
• Primary Completion: January 18, 2024
• Study Completion: January 18, 2024
• Last Updated: April 17, 2024

Record last verified: 2024-04

Locations

RU (1)