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Impact of Parathyroidectomy on Cardiovascular Calcification in Dialysis-dependent Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03937349
Recruitment Status : Recruiting
First Posted : May 3, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Ekaterina Parshina, Saint Petersburg State University, Russia

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 Vascular Calcification Dialysis

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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 14, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Minerals

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



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 ]


Information from the National Library of Medicine

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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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03937349


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

Locations
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Russian Federation
Saint-Petersburg State University, Clinic of advanced medical technologies n.a. N.I.Pirogov Recruiting
Saint Petersburg, Russian Federation, 190103
Contact: Ekaterina Parshina, MD    +7(812)676-25-21    pannn@yandex.ru   
Sponsors and Collaborators
Saint Petersburg State University, Russia
Investigators
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Principal Investigator: Ekaterina Parshina, MD Saint Petersburg State University, Russia
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Responsible Party: Ekaterina Parshina, Principal investigator, Saint Petersburg State University, Russia
ClinicalTrials.gov Identifier: NCT03937349    
Other Study ID Numbers: Calcification
First Posted: May 3, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bone Diseases
Chronic Kidney Disease-Mineral and Bone Disorder
Kidney Diseases
Renal Insufficiency, Chronic
Calcinosis
Vascular Calcification
Hyperparathyroidism
Hyperparathyroidism, Secondary
Urologic Diseases
Renal Insufficiency
Parathyroid Diseases
Endocrine System Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Musculoskeletal Diseases
Rickets
Bone Diseases, Metabolic
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders