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

Not Applicable

Completed

• Conditions: IGA Glomerulonephritis
• Interventions: Device: Holter

• Registration Number: NCT02527902
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

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

Not available

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2015-08
• Study First Submitted: 2015-08-18
• Study First Submitted QC: 2015-08-18
• Last Update Submitted: 2015-08-18
• Study First Posted: 2015-08-19
• Last Update Posted: 2015-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IgAN with GFR 60-89 ml/min/1.73 m2	Holter	Measure of ANS by holter device in IgAN patients with GFR 60-89 ml/min/1.73 m2
IgAN with GFR 15-29 ml/min/1.73 m2	Holter	Measure of ANS by holter device in IgAN patients with GFR 15-29 ml/min/1.73 m2
IgAN with GFR < 15ml/min/1.73 m2	Holter	Measure of ANS by holter device in IgAN patients with GFR \< 15ml/min/1.73 m2.
IgAN with glomerular filtration rate (GFR) >90 ml/min/1.73 m2	Holter	Measure of ANS by holter device in IgAN patients with glomerular filtration rate (GFR) \>90 ml/min/1.73 m2
IgAN with GFR 30-59 ml/min/1.73 m2	Holter	Measure of ANS by holter device in IgAN patients with GFR 30-59 ml/min/1.73 m2

Primary Outcome Measures

Name	Time	Method
Standard deviation of all R-R intervals (SDNN)	day 1	Comparison of Standard deviation of all R-R intervals (SDNN) between GFR category of IgNA

Trial Locations

Locations (1)

CHU Saint-Etienne; 🇫🇷 Saint-Etienne, France