Sub-total Parathyroidectomy Reduces Vascular Calcification in Haemodialysis Patients

March 10, 2011 updated by: Guangdong Provincial People's Hospital
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 .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • Guangdong General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Sub-total Parathyroidectomy
Procedure: Sub-total Parathyroidectomy
Sub-total Parathyroidectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in vascular calcium scores
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in left ventricular systolic and diastolic function
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Provincial People's Hospital

Investigators

  • Principal Investigator: Shi wei, MD PHD, Chinese Nephrology Committee

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Anticipated)

January 1, 2011

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

June 7, 2010

First Submitted That Met QC Criteria

June 8, 2010

First Posted (Estimate)

June 9, 2010

Study Record Updates

Last Update Posted (Estimate)

March 11, 2011

Last Update Submitted That Met QC Criteria

March 10, 2011

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8020

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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