Autonomic Nervous System (ANS) and Renal Function in Immunoglobin A (IgA) Nephropathy

August 18, 2015 updated by: Centre Hospitalier Universitaire de Saint Etienne

Autonomic Nervous System (ANS) Analysis According to Different Renal Function Stage in Immunoglobin A (IgA) Nephropathy

The estimation of the cardiovascular risk in the general population must take into account small renal disturbances, as the microalbuminuria. Conversely certain parameters of the cardiovascular risk influence the evolution of renal diseases, for example the arterial high blood pressure.

The measure of the activity of the autonomous nervous system, and especially the quantification of its variability, is a means to estimate the cardiovascular risk. The investigators formulate the hypothesis that the variability of the autonomous nervous system is an additional clinical element for the evaluation of the evolutionary risk of renal diseases.

The aim of this study is to compare the variability of the autonomous nervous system during the various evolutionary stages of the renal disease.

The renal disease studied will be IgA nephropathy (IgNA). IgNA is a histologically defined glomerulonephritis (rela biopsy) by the presence of deposits immunoglobulin A (IgA) in the renal mesangium (at list 1+) by immunofluorescence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

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

  • France
      • Saint-Etienne, France, 42055
        • Chu Saint-Etienne

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diagnosis of IgNA biopsy-proven free, informed, express and written

Exclusion Criteria:

  • IgNA secondary to Henoch-Schonlein purpura (HSP) or Systemic Lupus Erythematosus or alcoholic cirrhosis
  • current kidney transplantation
  • Hypertension treated or not,
  • Diseases interfering with ANS analysis: cardiac arrhythmia, beta-blocker therapy
  • diabetes

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

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IgAN with glomerular filtration rate (GFR) >90 ml/min/1.73 m2
Measure of ANS by holter device in IgAN patients with glomerular filtration rate (GFR) >90 ml/min/1.73 m2
Device: Holter
measure of ANS in IgAN patients
Experimental: IgAN with GFR 60-89 ml/min/1.73 m2
Measure of ANS by holter device in IgAN patients with GFR 60-89 ml/min/1.73 m2
Device: Holter
measure of ANS in IgAN patients
Experimental: IgAN with GFR 30-59 ml/min/1.73 m2
Measure of ANS by holter device in IgAN patients with GFR 30-59 ml/min/1.73 m2
Device: Holter
measure of ANS in IgAN patients
Experimental: IgAN with GFR 15-29 ml/min/1.73 m2
Measure of ANS by holter device in IgAN patients with GFR 15-29 ml/min/1.73 m2
Device: Holter
measure of ANS in IgAN patients
Experimental: IgAN with GFR < 15ml/min/1.73 m2
Measure of ANS by holter device in IgAN patients with GFR < 15ml/min/1.73 m2.
Device: Holter
measure of ANS in IgAN patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Standard deviation of all R-R intervals (SDNN)
Time Frame: day 1
Comparison of Standard deviation of all R-R intervals (SDNN) between GFR category of IgNA
day 1

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Eric Alamartine, PhD, Chu Saint-Etienne

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

January 1, 2011

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

August 18, 2015

First Submitted That Met QC Criteria

August 18, 2015

First Posted (Estimate)

August 19, 2015

Study Record Updates

Last Update Posted (Estimate)

August 19, 2015

Last Update Submitted That Met QC Criteria

August 18, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1008123

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.

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