Clinical trial NCT00745719: Parathyroidectomy in Endstage Renal Disease
Official title: A Pilot Study to Evaluate the Efficacy of Total Parathyroidectomy in Retarding Cardiovascular Calcification in End-stage Renal Disease Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endstage Renal Disease
Keywords: parathyroidectomy
cardiovascular
bone
endstage renal disease
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2008-09-03
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Parathyroidectomy group versus natural disease control group
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in vascular and valvular calcium scores
timeFrame: 12 months
Secondary outcomes:
measure: Change in bone mineral density
timeFrame: 12 months
measure: change in aortic pulse wave velocity,
timeFrame: 12 months
measure: change in left ventricular mass, volume and function
timeFrame: 12 months
measure: changes in quality of life scores
timeFrame: 12 months
measure: changes in iPTH
timeFrame: 6 and 12 months
measure: changes in Serum calcium and phosphate
timeFrame: 6 and 12 months
measure: changes in alkaline phosphatase
timeFrame: 6 and 12 months
measure: changes in handgrip strength
timeFrame: 12 months
measure: changes in subjective global assessment
timeFrame: 6 and 12 months
measure: changes in serum albumin
timeFrame: 6 and 12 months
measure: changes in inflammatory marker
timeFrame: 12 months
measure: changes in HOMA index
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital, Tung Wah Hospital
Study officials:
affiliation: Queen Mary Hospital, University of Hong Kong
name: Angela YM Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: