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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

Impact of Parathyroidectomy on Cardiovascular Calcification in Dialysis-dependent Patients

Clinicaltrials.gov identifier NCT03937349

Recruitment Status Recruiting

First Posted May 3, 2019

Last update posted May 16, 2019

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:Secondary Hyperparathyroidism
    Chronic Kidney Disease Mineral and Bone Disorder
    Dialysis
    Vascular Calcification
  • Intervention/Treatment:
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Observational
  • Estimated 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 2019
  • Estimated Primary Completion Date: December 2020
  • Estimated Study Completion Date: December 2020
Outcome Measures
  • Primary Outcome Measures: 1. Change in coronary artery calcium score measured with CT [ Time Frame: 12 months ]
  • 2. Change in vascular calcification score measured with semi-quantitative (Kauppila) test [ Time Frame: 12 months ]
  • Secondary Outcome Measures: 1. Change in heart valve calcium score [ Time Frame: 12 months ]
  • 2. Change in intact parathyroid hormone (iPTH) level [ Time Frame: 12 months ]
  • 3. Change in serum calcium level [ Time Frame: 12 months ]
  • 4. Change in serum phosphate level [ Time Frame: 12 weeks ]
  • 5. Change in alkaline phosphatase [ Time Frame: 12 months ]
  • 6. Serious adverse events (cardiovascular events, death, fractures, emergency hospital admissions) during the follow-up period [ Time Frame: 12 months ]
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • 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
Criteria

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
Contacts

Contact: Ekaterina Parshina, MD +7(812)676-25-25 pannn@yandex.ru

Locations

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

Sponsors and Collaborators

Saint Petersburg State University, Russia

Investigators

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

More Information
  • Responsible Party: Saint Petersburg State University, Russia
  • ClinicalTrials.gov Identifier: NCT03937349 History of Changes
  • Other Study ID Numbers: Calcification
  • First Posted: May 3, 2019 Key Record Dates
  • Last Update Posted: May 16, 2019
  • Last Verified: May 2019
  • 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