Sub-total Parathyroidectomy Reduces Vascular Calcification in Haemodialysis Patients

Hemodialysis Clinical Trial

Official title:

Sub-total Parathyroidectomy Reduces Vascular Calcification in Haemodialysis Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01140490
• Other study ID #: 8020
• Status: Recruiting
• Phase: N/A
• First received: June 7, 2010
• Last updated: March 10, 2011
• Start date: January 2009
• Est. completion date: December 2011

Study information

• Verified date: January 2009
• Source: Guangdong General Hospital
• Contact: Shi Wei, MD and PHD
• Phone: 8602083827812
• Email: shiw_ggh[@]126.com
• Is FDA regulated: No
• Health authority: Guangdong Province: Ethics Committee
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Calcinosis
• Hemodialysis
• Vascular Calcification

Intervention

Procedure:
• Sub-total Parathyroidectomy
Sub-total Parathyroidectomy

Locations

Country	Name	City	State
China	Guangdong General Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in vascular calcium scores		12 months	No
Secondary	Change in left ventricular systolic and diastolic function		12 months	No