Parathyroidectomy in Endstage Renal Disease

The University of Hong Kong122 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

122

Conditions

Endstage Renal Disease

Interventions

parathyroidectomyPROCEDURE

total parathyroidectomy with forearm autografting

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Queen Mary Hospital, Tung Wah Hospital

Hong Kong, Hong Kong

Outcomes

Primary Outcomes

Change in vascular and valvular calcium scores

Time frame: 12 months

Secondary Outcomes

Change in bone mineral density

Time frame: 12 months

change in aortic pulse wave velocity,

Time frame: 12 months

change in left ventricular mass, volume and function

Time frame: 12 months

changes in quality of life scores

Time frame: 12 months

changes in iPTH

Time frame: 6 and 12 months

changes in Serum calcium and phosphate

Time frame: 6 and 12 months

changes in alkaline phosphatase

Time frame: 6 and 12 months

changes in handgrip strength

Time frame: 12 months

changes in subjective global assessment

Time frame: 6 and 12 months

changes in serum albumin

Time frame: 6 and 12 months

changes in inflammatory marker

Time frame: 12 months

changes in HOMA index

Data from ClinicalTrials.gov

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