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NCT Number: NCT03937349

Impact of Parathyroidectomy on Cardiovascular Calcification in Dialysis-dependent Patients

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Saint Petersburg, 190103, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Primary hyperparathyroidosis as a cause of ESRD

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Saint Petersburg State University, Russia

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
May 3, 2019
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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