Parathyroidectomy in Endstage Renal Disease

Endstage Renal Disease Clinical Trial

Official title:

A Pilot Study to Evaluate the Efficacy of Total Parathyroidectomy in Retarding Cardiovascular Calcification in End-stage Renal Disease Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00745719
• Other study ID #: A111-102
• Status: Completed
• Phase: N/A
• Start date: March 2007
• Est. completion date: January 2012

Study information

• Verified date: August 2020
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: January 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Endstage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Procedure:
• parathyroidectomy
total parathyroidectomy with forearm autografting

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital, Tung Wah Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in vascular and valvular calcium scores		12 months
Secondary	Change in bone mineral density		12 months
Secondary	change in aortic pulse wave velocity,		12 months
Secondary	change in left ventricular mass, volume and function		12 months
Secondary	changes in quality of life scores		12 months
Secondary	changes in iPTH		6 and 12 months
Secondary	changes in Serum calcium and phosphate		6 and 12 months
Secondary	changes in alkaline phosphatase		6 and 12 months
Secondary	changes in handgrip strength		12 months
Secondary	changes in subjective global assessment		6 and 12 months
Secondary	changes in serum albumin		6 and 12 months
Secondary	changes in inflammatory marker		12 months
Secondary	changes in HOMA index		6 and 12 months