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Parathyroidectomy in Endstage Renal Disease

The University of Hong Kong (HKU) logo

The University of Hong Kong (HKU)

Status

Completed

Conditions

Endstage Renal Disease

Treatments

Procedure: parathyroidectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT00745719
A111-102

Details and patient eligibility

About

To test the hypothesis that total parathyroidectomy retards cardiovascular calcification, improves bone mineral density, reduces cardiac hypertrophy and arterial stiffening in end-stage renal disease patients on maintenance dialysis.

Full description

Secondary hyperparathyroidism (SHPT) in patients with end-stage renal disease contributes to increased cardiovascular morbidity and mortality via different mechanisms. Uncontrolled hyperparathyroidism is associated with left ventricular hypertrophy and has been implicated in the development of cardiac interstitial fibrosis and diastolic dysfunction.

Enrollment

122 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Endstage renal disease patients receiving either long-term hemodialysis or peritoneal dialysis treatment, with elevated intact parathyroid hormone (iPTH) levels > 500pg/ml on two or more occasions.
  • Patients with parathyroid nodular or diffuse hyperplasia identified by ultrasound imaging or radioisotope scan.
  • Patients who provide informed consent for the study.

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
  • Patients with calciphylaxis
  • Patients with underlying active malignancy
  • Patients with contraindication for MRI

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

122 participants in 1 patient group

1
Experimental group
Description:
surgical total parathyroidectomy with forearm autografting
Treatment:
Procedure: parathyroidectomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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