Endstage Renal Disease
Conditions
Keywords
parathyroidectomy, cardiovascular, bone, endstage renal disease
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.
Interventions
PROCEDUREparathyroidectomy
total parathyroidectomy with forearm autografting
Sponsors
The University of Hong Kong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Parathyroidectomy group versus natural disease control group
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in vascular and valvular calcium scores | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Change in bone mineral density | 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 |
| changes in alkaline phosphatase | 6 and 12 months |
Countries
Hong Kong
Outcome results
None listed