Parathyroidectomy in Endstage Renal Disease
Not Applicable
Completed
- Conditions
- Endstage Renal Disease
- Interventions
- Procedure: parathyroidectomy
- Registration Number
- NCT00745719
- Lead Sponsor
- The University of Hong Kong
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 122
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 parathyroidectomy surgical total parathyroidectomy with forearm autografting
- Primary Outcome Measures
Name Time Method Change in vascular and valvular calcium scores 12 months
- Secondary Outcome Measures
Name Time Method change in aortic pulse wave velocity, 12 months changes in inflammatory marker 12 months Change in bone mineral density 12 months changes in quality of life scores 12 months changes in subjective global assessment 6 and 12 months changes in alkaline phosphatase 6 and 12 months changes in handgrip strength 12 months change in left ventricular mass, volume and function 12 months changes in Serum calcium and phosphate 6 and 12 months changes in HOMA index 6 and 12 months changes in iPTH 6 and 12 months changes in serum albumin 6 and 12 months
Trial Locations
- Locations (1)
Queen Mary Hospital, Tung Wah Hospital
ðŸ‡ðŸ‡°Hong Kong, Hong Kong