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Sub-total Parathyroidectomy Reduces Vascular Calcification in Haemodialysis Patients

Primary Purpose

Hemodialysis

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Sub-total Parathyroidectomy

About this trial

This is an interventional prevention trial for Hemodialysis focused on measuring Hemodialysis, Sub-total Parathyroidectomy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Guangdong General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

Sub-total Parathyroidectomy

Arm Description

Outcomes

Primary Outcome Measures

Change in vascular calcium scores

Secondary Outcome Measures

Change in left ventricular systolic and diastolic function

Full Information

NCT ID

NCT01140490

First Posted

June 7, 2010

Last Updated

March 10, 2011

Sponsor

Guangdong Provincial People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01140490

Brief Title

Sub-total Parathyroidectomy Reduces Vascular Calcification in Haemodialysis Patients

Official Title

Sub-total Parathyroidectomy Reduces Vascular Calcification in Haemodialysis Patients

Study Type

Interventional

2. Study Status

Record Verification Date

January 2009

Overall Recruitment Status

Unknown status

Study Start Date

January 2009 (undefined)

Primary Completion Date

January 2011 (Anticipated)

Study Completion Date

December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Guangdong Provincial People's Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 .

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemodialysis

Keywords

Hemodialysis, Sub-total Parathyroidectomy

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sub-total Parathyroidectomy

Arm Type

No Intervention

Intervention Type

Procedure

Intervention Name(s)

Sub-total Parathyroidectomy

Intervention Description

Sub-total Parathyroidectomy

Primary Outcome Measure Information:

Title

Change in vascular calcium scores

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Change in left ventricular systolic and diastolic function

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shi Wei, MD and PHD

Phone

8602083827812

Ext

62027

shiw_ggh@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

Liu shuangxin, MD and PHD

Phone

8602083827812

Ext

62027

mplsxi@yahoo.com.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shi wei, MD PHD

Organizational Affiliation

Chinese Nephrology Committee

Official's Role

Principal Investigator

Facility Information:

Facility Name

Guangdong General Hospital

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510080

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Liu shuangxin, MD and Phd

Phone

8602083827812

Ext

62027

mplsxi@yahoo.com.cn

12. IPD Sharing Statement

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Sub-total Parathyroidectomy Reduces Vascular Calcification in Haemodialysis Patients

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