Impact of Parathyroidectomy on Cardiovascular Calcification in Dialysis-dependent Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Secondary Hyperparathyroidism; Dialysis; Vascular Calcification; Chronic Kidney Disease Mineral and Bone Disorder

• Study Type: Observational
• Enrollment (Actual): 63

Contacts and Locations

Study Locations

• Russian Federation
  • Saint Petersburg, Russian Federation, 190103
    • Saint-Petersburg State University, Clinic of advanced medical technologies n.a. N.I.Pirogov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Serious adverse events (cardiovascular events, death, fractures, emergency hospital admissions) during the follow-up period	18 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2019
• Primary Completion (Actual): January 18, 2024
• Study Completion (Actual): January 18, 2024

Study Registration Dates

• First Submitted: May 1, 2019
• First Submitted That Met QC Criteria: May 2, 2019
• First Posted (Actual): May 3, 2019

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Urologic Diseases; Endocrine System Diseases; Disease Attributes; Renal Insufficiency; Nutrition Disorders; Musculoskeletal Diseases; Parathyroid Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Bone Diseases, Metabolic; Calcium Metabolism Disorders; Rickets; Vitamin D Deficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Hyperparathyroidism; Bone Diseases; Hyperparathyroidism, Secondary; Chronic Kidney Disease-Mineral and Bone Disorder; Calcinosis; Vascular Calcification
• Other Study ID Numbers: Calcification

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No