The Effect of Parathyroidectomy on Renal Function, Endothelial Function, and Blood Pressure

NCT ID: NCT00452049

Last Updated: 2012-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-04-30

Brief Summary

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Secondary hyperparathyroidism (HPT) is a known complication of chronic renal failure. Elevated concentrations of parathyroid hormone (PTH) play a role not only in the pathogenesis of renal bone disease, but also in the development of cardiovascular risk factors such as disturbed lipid metabolism, glucose intolerance, and hypertension. HPT is also known to play an important role in the development of structural abnormalities of both large arteries and the heart (left ventricular hypertrophy, interstitial fibrosis). In the last couple of years there has been increasing evidence from animal studies that the endothelium is a target organ of PTH.

Hypothesis: PTH has clinically relevant effects on renal hemodynamics, renal function and endothelial function.

Aims:

1. To evaluate the effect of parathyroidectomy (PTX) on renal hemodynamics in stable renal transplant recipients
2. To evaluate the effect of PTX on endothelial function in stable renal transplant recipients/chronic kidney disease (CKD) stage 5 patients
3. To evaluate the effect of PTX on blood pressure in stable renal transplant recipients/CKD stage 5 patients

Detailed Description

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Conditions

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Hyperparathyroidism Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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parathyroidectomy

parathyroidectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Stable renal transplant recipients/CKD stage 5D patients.
2. Age between 18 years and 85 years.
3. Signed informed consent.
4. PTX scheduled because of severe hyperparathyroidism (day 0)
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Evenepoel Pieter

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pieter Evenepoel, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

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University Hopsital Leuven

Leuven, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Pieter Evenepoel, MD, PhD

Role: CONTACT

003216344580

Facility Contacts

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Pieter Evenepoel, MD, PhD

Role: primary

003216344580

References

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Evenepoel P, Claes K, Viaene L, Bammens B, Meijers B, Naesens M, Sprangers B, Kuypers D. Decreased Circulating Sclerostin Levels in Renal Transplant Recipients With Persistent Hyperparathyroidism. Transplantation. 2016 Oct;100(10):2188-93. doi: 10.1097/TP.0000000000001311.

Reference Type DERIVED
PMID: 27379556 (View on PubMed)

Other Identifiers

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ML3052

Identifier Type: -

Identifier Source: org_study_id

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