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

NCT ID: NCT02527902

Last Updated: 2015-08-19

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

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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IGA Glomerulonephritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Holter

Intervention Type DEVICE

measure of ANS in IgAN patients

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

Group Type EXPERIMENTAL

Holter

Intervention Type DEVICE

measure of ANS in IgAN patients

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

Group Type EXPERIMENTAL

Holter

Intervention Type DEVICE

measure of ANS in IgAN patients

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

Group Type EXPERIMENTAL

Holter

Intervention Type DEVICE

measure of ANS in IgAN patients

IgAN with GFR < 15ml/min/1.73 m2

Measure of ANS by holter device in IgAN patients with GFR \< 15ml/min/1.73 m2.

Group Type EXPERIMENTAL

Holter

Intervention Type DEVICE

measure of ANS in IgAN patients

Interventions

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Holter

measure of ANS in IgAN patients

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric Alamartine, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

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CHU Saint-Etienne

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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1008123

Identifier Type: -

Identifier Source: org_study_id

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