Parathyroidectomy in Endstage Renal Disease

Study Overview
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Brief Summary
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To test the hypothesis that total parathyroidectomy retards cardiovascular calcification, improves bone mineral density, reduces cardiac hypertrophy and arterial stiffening in end-stage renal disease patients on maintenance dialysis.

Detailed Description
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Secondary hyperparathyroidism (SHPT) in patients with end-stage renal disease contributes to increased cardiovascular morbidity and mortality via different mechanisms. Uncontrolled hyperparathyroidism is associated with left ventricular hypertrophy and has been implicated in the development of cardiac interstitial fibrosis and diastolic dysfunction.

Official Title
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A Pilot Study to Evaluate the Efficacy of Total Parathyroidectomy in Retarding Cardiovascular Calcification in End-stage Renal Disease Patients

Conditions
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Endstage Renal Disease

Intervention / Treatment
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* Procedure: parathyroidectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Endstage renal disease patients receiving either long-term hemodialysis or peritoneal dialysis treatment, with elevated intact parathyroid hormone (iPTH) levels > 500pg/ml on two or more occasions. Patients with parathyroid nodular or diffuse hyperplasia identified by ultrasound imaging or radioisotope scan. Patients who provide informed consent for the study. Exclusion Criteria: Patients with significant background valvular heart disease Patients who are unfit for general anaesthesia Patients with acute myocardial infarction within recent two months Patients with poor general condition Patients with plans for living related kidney transplant within 1 year Patients with previous history of parathyroidectomy Patients with calciphylaxis Patients with underlying active malignancy Patients with contraindication for MRI

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Parathyroidectomy group versus natural disease control group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>surgical total parathyroidectomy with forearm autografting | Procedure: parathyroidectomy<br>* total parathyroidectomy with forearm autografting<br>* Other names: total parathyroidectomy with forearm autografting;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in vascular and valvular calcium scores |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in bone mineral density |  | 12 months | 
| change in aortic pulse wave velocity, |  | 12 months | 
| change in left ventricular mass, volume and function |  | 12 months | 
| changes in quality of life scores |  | 12 months | 
| changes in iPTH |  | 6 and 12 months | 
| changes in Serum calcium and phosphate |  | 6 and 12 months | 
| changes in alkaline phosphatase |  | 6 and 12 months | 
| changes in handgrip strength |  | 12 months | 
| changes in subjective global assessment |  | 6 and 12 months | 
| changes in serum albumin |  | 6 and 12 months | 
| changes in inflammatory marker |  | 12 months | 
| changes in HOMA index |  | 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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parathyroidectomy, cardiovascular, bone, endstage renal disease