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Sub-total Parathyroidectomy Reduces Vascular Calcification in Haemodialysis Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Guangdong General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Guangdong General Hospital
ClinicalTrials.gov Identifier:
NCT01140490
First received: June 7, 2010
Last updated: March 10, 2011
Last verified: January 2009
History of Changes
  Purpose

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 Intervention
Hemodialysis
 Procedure: Sub-total Parathyroidectomy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Sub-total Parathyroidectomy Reduces Vascular Calcification in Haemodialysis Patients

Resource links provided by NLM:

MedlinePlus related topics: Dialysis
U.S. FDA Resources

Further study details as provided by Guangdong General Hospital:

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

Secondary Outcome Measures:
  • Change in left ventricular systolic and diastolic function [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Sub-total Parathyroidectomy Procedure: Sub-total Parathyroidectomy
Sub-total Parathyroidectomy

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01140490

Contacts
Contact: Shi Wei, MD and PHD 8602083827812 ext 62027 shiw_ggh@126.com
Contact: Liu shuangxin, MD and PHD 8602083827812 ext 62027 mplsxi@yahoo.com.cn

Locations
China, Guangdong
Guangdong General Hospital Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Liu shuangxin, MD and Phd     8602083827812 ext 62027     mplsxi@yahoo.com.cn    
Sponsors and Collaborators
Guangdong General Hospital
Investigators
Principal Investigator: Shi wei, MD PHD Chinese Nephrology Committee
  More Information

No publications provided

Responsible Party: Guangdong General Hospital, Department of nephrology
ClinicalTrials.gov Identifier: NCT01140490     History of Changes
Other Study ID Numbers: 8020
Study First Received: June 7, 2010
Last Updated: March 10, 2011
Health Authority: Guangdong Province: Ethics Committee

Keywords provided by Guangdong General Hospital:
Hemodialysis
Sub-total Parathyroidectomy

Additional relevant MeSH terms:
Calcinosis
Calcium Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 16, 2013