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Parathyroidectomy in Endstage Renal Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00745719
First received: September 1, 2008
Last updated: May 7, 2012
Last verified: May 2012
History of Changes

September 1, 2008
May 7, 2012
March 2007
September 2011   (final data collection date for primary outcome measure)
Change in vascular and valvular calcium scores [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00745719 on ClinicalTrials.gov Archive Site
Change in bone mineral density, left ventricular mass and volume, left ventricular systolic and diastolic function, augmentation index and pulse wave velocity, inflammatory marker, HOMA, quality of life score, handgrip, Parathyroid hormone level [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Change in left ventricular mass and volume, left ventricular systolic and diastolic function, augmentation index and pulse wave velocity, inflammatory marker, HOMA, quality of life score, handgrip, bone biopsy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Parathyroidectomy in Endstage Renal Disease
A Pilot Study to Evaluate the Efficacy of Total Parathyroidectomy in Retarding Cardiovascular Calcification in End-stage Renal Disease Patients

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.

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.
Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Endstage Renal Disease
Procedure: parathyroidectomy
total parathyroidectomy with forearm autografting
Other Name: total parathyroidectomy with forearm autografting
Experimental: 1
parathyroidectomy
Intervention: Procedure: parathyroidectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
January 2012
September 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Hong Kong
 
NCT00745719
A111-102
Yes
The University of Hong Kong
The University of Hong Kong
Not Provided
Principal Investigator: Angela YM Wang, MD, PhD Queen Mary Hospital, University of Hong Kong
The University of Hong Kong
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP