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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

    February 16, 2021

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:Dialysis
    Secondary Hyperparathyroidism
    Chronic Kidney Disease Mineral and Bone Disorder
    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 2022
  • Estimated Study Completion Date: December 2022

Outcome Measures

  • Primary Outcome Measures: 1. Change in coronary artery calcium score measured with CT [ Time Frame: 18 months ]
  • 2. Change in vascular calcification score measured with semi-quantitative (Kauppila) test [ Time Frame: 18 months ]
  • Secondary Outcome Measures: 1. Change in heart valve calcium score [ Time Frame: 18 months ]
  • 2. Change in intact parathyroid hormone (iPTH) level [ Time Frame: 18 months ]
  • 3. Change in serum calcium level [ Time Frame: 18 months ]
  • 4. Change in serum phosphate level [ Time Frame: 18weeks ]
  • 5. Change in alkaline phosphatase [ Time Frame: 18 months ]
  • 6. Serious adverse events (cardiovascular events, death, fractures, emergency hospital admissions) during the follow-up period [ Time Frame: 18 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: February 16, 2021
  • Last Verified: February 2021
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Renal Insufficiency, Chronic
    Hyperparathyroidism
    Hyperparathyroidism, Secondary
    Vascular Calcification
    Bone Diseases
    Kidney Diseases
    Chronic Kidney Disease-Mineral and Bone Disorder
    Calcinosis