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

May 28, 2012 updated by: Evenepoel Pieter, Universitaire Ziekenhuizen KU Leuven

Observational Study to Evaluate the Effect of Parathyroidectomy on Renal Function, Endothelial Function and Blood Pressure

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:

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Procedure: parathyroidectomy

Study Type

Observational

Enrollment (Anticipated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Belgium
- - Leuven, Belgium, 3000
    - Recruiting
    - University Hopsital Leuven
    - Contact:
      
      Pieter Evenepoel, MD, PhD
      
      Phone Number: 003216344580
      
      Email: pieter.evenepoel@uz.kuleuven.ac.be

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Renal transplant recipients

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

Principal Investigator: Pieter Evenepoel, MD, PhD, Universitaire Ziekenhuizen KU Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Study Registration Dates

First Submitted

March 23, 2007

First Submitted That Met QC Criteria

March 23, 2007

First Posted (Estimate)

March 26, 2007

Study Record Updates

Last Update Posted (Estimate)

May 30, 2012

Last Update Submitted That Met QC Criteria

May 28, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

ML3052

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.