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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
  Purpose

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.


Condition Intervention Phase
Endstage Renal Disease
 Procedure: parathyroidectomy
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study to Evaluate the Efficacy of Total Parathyroidectomy in Retarding Cardiovascular Calcification in End-stage Renal Disease Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • Change in vascular and valvular calcium scores [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 50
Study Start Date: March 2007
Study Completion Date: January 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
parathyroidectomy
 Procedure: parathyroidectomy
total parathyroidectomy with forearm autografting
Other Name: total parathyroidectomy with forearm autografting

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00745719

Locations
Hong Kong
Queen Mary Hospital, Tung Wah Hospital
Hong Kong, Hong Kong, 0000
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Angela YM Wang, MD, PhD Queen Mary Hospital, University of Hong Kong
  More Information

No publications provided

Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT00745719     History of Changes
Other Study ID Numbers: A111-102
Study First Received: September 1, 2008
Last Updated: May 7, 2012
Health Authority: Hong Kong: Ethics Committee

Keywords provided by The University of Hong Kong:
parathyroidectomy
cardiovascular
bone
endstage renal disease

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on June 18, 2013