Parathyroidectomy in Endstage Renal Disease - Tabular View

Tracking Information

First Received Date ^ICMJE

September 1, 2008

Last Updated Date

September 1, 2008

Start Date ^ICMJE

April 2007

Estimated Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Parathyroidectomy in Endstage Renal Disease

Official Title ^ICMJE

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

Brief Summary

To test the hypothesis that total parathyroidectomy retards cardiovascular calcification, 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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label, Active Control, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Endstage Renal Disease

Intervention ^ICMJE

Procedure: parathyroidectomy

Study Arms / Comparison Groups

Experimental: parathyroidectomy

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2010

Estimated Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Angela YM Wang, MD, FRCP

28554111 ext 4949

aymwang@hku.hk

Location Countries ^ICMJE

Hong Kong

Administrative Information

NCT ID ^ICMJE

NCT00745719

Responsible Party

Dr Wang Angela Yee-Moon, Queen Mary Hospital, University of Hong Kong

Study ID Numbers ^ICMJE

A111-102

Study Sponsor ^ICMJE

The University of Hong Kong

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Angela YM Wang, MD, FRCP

Queen Mary Hospital, University of Hong Kong

Information Provided By

The University of Hong Kong

Verification Date

September 2008

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