Impact of Parathyroidectomy on Cardiovascular Calcification in Dialysis-dependent Patients

NCT ID: NCT03937349

Last Updated: 2024-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

63 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-14

Study Completion Date

2024-01-18

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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sPTx group

Patients underwent subtotal parathyroidectomy due to severe secondary hyperparathyroidism

No interventions assigned to this group

TPTx+AT group

Patients underwent total parathyroidectomy with immediate autotransplantation of parathyroid tissue due to severe secondary hyperparathyroidism

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Saint Petersburg State University, Russia

OTHER

Sponsor Role lead

Responsible Party

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Ekaterina Parshina

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ekaterina Parshina, MD

Role: PRINCIPAL_INVESTIGATOR

Saint Petersburg State University, Russia

Locations

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

Saint Petersburg, , Russia

Site Status

Countries

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Russia

Other Identifiers

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Calcification

Identifier Type: -

Identifier Source: org_study_id

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