Sub-total Parathyroidectomy Reduces Vascular Calcification in Haemodialysis Patients

Not Applicable

• Conditions: Hemodialysis
• Interventions: Procedure: Sub-total Parathyroidectomy

• Registration Number: NCT01140490
• Lead Sponsor: Guangdong Provincial People's 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 .

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 Timeline

• Status Verified: 2009-01
• Study Start: 2009-01
• Study First Submitted: 2010-06-07
• Study First Submitted QC: 2010-06-08
• Study First Posted: 2010-06-09
• Primary Completion: 2011-01
• Last Update Submitted: 2011-03-10
• Last Update Posted: 2011-03-11
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sub-total Parathyroidectomy	Sub-total Parathyroidectomy	-

Primary Outcome Measures

Name	Time	Method
Change in vascular calcium scores	12 months

Secondary Outcome Measures

Name	Time	Method
Change in left ventricular systolic and diastolic function	12 months

Trial Locations

Locations (1)

Guangdong General Hospital; 🇨🇳 Guangzhou, Guangdong, China