Sub-total Parathyroidectomy Reduces Vascular Calcification in Haemodialysis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01140490
Recruitment Status : Unknown
Verified January 2009 by Guangdong General Hospital.
Recruitment status was:  Recruiting
First Posted : June 9, 2010
Last Update Posted : March 11, 2011
Information provided by:
Guangdong General Hospital

Brief Summary:
The aim of this study was to evaluate whether successful sub-total parathyroidectomy retards cardiovascular calcification in patients with hemodialysis and to investigate the mechanism .

Condition or disease Intervention/treatment Phase
Hemodialysis Procedure: Sub-total Parathyroidectomy Not Applicable

Detailed Description:
Hyperparathyroidism (PHPT) in patients with end-stage renal disease have been shown to have an increased morbidity and mortality mainly due to cardiovascular disease. The precise mechanism of cardiovascular disease in PHPT is not well understood . The excess in cardiovascular mortality is significantly and independently related to serum calcium, the connection between the biochemical disturbances and the cardiovascular disorders in PHPT patients is not necessarily a cause-and-effect relationship. Indeed, the impact of surgical cure of hyperparathyroidism on cardiovascular risk factors and mortality is controversial. Some studies suggest that cardiovascular risk markers remained unaltered after Sub-total Parathyroidectomy.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Sub-total Parathyroidectomy Reduces Vascular Calcification in Haemodialysis Patients
Study Start Date : January 2009
Estimated Primary Completion Date : January 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Minerals
U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Sub-total Parathyroidectomy Procedure: Sub-total Parathyroidectomy
Sub-total Parathyroidectomy

Primary Outcome Measures :
  1. Change in vascular calcium scores [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Change in left ventricular systolic and diastolic function [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • The patients receiving hemodialysis treatment, with elevated intact parathyroid hormone (iPTH) levels > 800pg/ml on two or more occasions.
  • Patients with parathyroid nodular or diffuse hyperplasia identified by ultrasound imaging or radioisotope scan.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01140490

Contact: Shi Wei, MD and PHD 8602083827812 ext 62027
Contact: Liu shuangxin, MD and PHD 8602083827812 ext 62027

China, Guangdong
Guangdong General Hospital Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Liu shuangxin, MD and Phd    8602083827812 ext 62027   
Sponsors and Collaborators
Guangdong General Hospital
Principal Investigator: Shi wei, MD PHD Chinese Nephrology Committee

Responsible Party: Guangdong General Hospital, Department of nephrology Identifier: NCT01140490     History of Changes
Other Study ID Numbers: 8020
First Posted: June 9, 2010    Key Record Dates
Last Update Posted: March 11, 2011
Last Verified: January 2009

Keywords provided by Guangdong General Hospital:
Sub-total Parathyroidectomy

Additional relevant MeSH terms:
Vascular Calcification
Calcium Metabolism Disorders
Metabolic Diseases