Parathyroidectomy in Endstage Renal Disease - Full Text View

Sponsor:	The University of Hong Kong
Information provided by:	The University of Hong Kong
ClinicalTrials.gov Identifier:	NCT00745719

Purpose

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.

Condition	Intervention
Endstage Renal Disease	Procedure: parathyroidectomy

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:

MedlinePlus related topics: Kidney Failure

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 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 ]

Estimated Enrollment:	50
Study Start Date:	April 2007
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 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

Contacts

Contact: Angela YM Wang, MD, PhD

28554111 ext 4949

aymwang@hku.hk

Locations

Hong Kong
Queen Mary Hospital, Tung Wah Hospital	Recruiting
Hong Kong, Hong Kong, 0000
Contact: Angela YM Wang, MD, FRCP 28554111 ext 4949 aymwang@hku.hk
Principal Investigator: Angela YM Wang, MD, FRCP

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:	Dr Wang Angela Yee-Moon, Queen Mary Hospital, 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:	October 6, 2010
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 February 09, 2012