A Pilot Study to Evaluate the Efficacy of Total Parathyroidectomy in Retarding Cardiovascular Calcification in End-stage Renal Disease Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- The University of Hong Kong
- Enrollment
- 122
- Locations
- 1
- Primary Endpoint
- Change in vascular and valvular calcium scores
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
1
surgical total parathyroidectomy with forearm autografting
Intervention: parathyroidectomy (Procedure)
Outcomes
Primary Outcomes
Change in vascular and valvular calcium scores
Time Frame: 12 months
Secondary Outcomes
- change in aortic pulse wave velocity,(12 months)
- changes in alkaline phosphatase(6 and 12 months)
- changes in iPTH(6 and 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 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 serum albumin(6 and 12 months)
Investigators
Dr. Angela Yee-Moon Wang
Honorary Associate Professor
The University of Hong Kong