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Completed

NCT Number: NCT00745719

Parathyroidectomy in Endstage Renal Disease

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.

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Key information

Conditions

Endstage Renal Disease

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Mary Hospital, Tung Wah Hospital

Hong Kong, 0000

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Parathyroidectomy

Procedure

total parathyroidectomy with forearm autografting

Other names: total parathyroidectomy with forearm autografting

Primary outcomes

  1. Change in vascular and valvular calcium scores

    Time frame: 12 months

Secondary outcomes

  1. Change in bone mineral density

    Time frame: 12 months

  2. change in aortic pulse wave velocity,

    Time frame: 12 months

  3. change in left ventricular mass, volume and function

    Time frame: 12 months

  4. changes in quality of life scores

    Time frame: 12 months

  5. changes in iPTH

    Time frame: 6 and 12 months

  6. changes in Serum calcium and phosphate

    Time frame: 6 and 12 months

  7. changes in alkaline phosphatase

    Time frame: 6 and 12 months

  8. changes in handgrip strength

    Time frame: 12 months

  9. changes in subjective global assessment

    Time frame: 6 and 12 months

  10. changes in serum albumin

    Time frame: 6 and 12 months

  11. changes in inflammatory marker

    Time frame: 12 months

  12. changes in HOMA index

    Time frame: 6 and 12 months

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

A Pilot Study to Evaluate the Efficacy of Total Parathyroidectomy in Retarding Cardiovascular Calcification in End-stage Renal Disease Patients

Important dates

Study start
2007
Primary completion
2011
Study completion
2012
First posted
Sep 3, 2008
Registry last updated
Aug 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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