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

NCT02527902 | Completed

• 1 other identifier: 1008123
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

IGA Glomerulonephritis

Keywords

IGA Glomerulonephritis; Autonomic nervous system; ANS

Outcome Measures

Primary Outcomes (1)

• Standard deviation of all R-R intervals (SDNN)

  Comparison of Standard deviation of all R-R intervals (SDNN) between GFR category of IgNA

  day 1

Study Arms (5)

IgAN with glomerular filtration rate (GFR) >90 ml/min/1.73 m2

EXPERIMENTAL

Measure of ANS by holter device in IgAN patients with glomerular filtration rate (GFR) \>90 ml/min/1.73 m2

Device: Holter

IgAN with GFR 60-89 ml/min/1.73 m2

EXPERIMENTAL

Measure of ANS by holter device in IgAN patients with GFR 60-89 ml/min/1.73 m2

Device: Holter

IgAN with GFR 30-59 ml/min/1.73 m2

EXPERIMENTAL

Measure of ANS by holter device in IgAN patients with GFR 30-59 ml/min/1.73 m2

Device: Holter

IgAN with GFR 15-29 ml/min/1.73 m2

EXPERIMENTAL

Measure of ANS by holter device in IgAN patients with GFR 15-29 ml/min/1.73 m2

Device: Holter

IgAN with GFR < 15ml/min/1.73 m2

EXPERIMENTAL

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

Device: Holter

Interventions

Holter DEVICE

measure of ANS in IgAN patients

IgAN with GFR 15-29 ml/min/1.73 m2; IgAN with GFR 30-59 ml/min/1.73 m2; IgAN with GFR 60-89 ml/min/1.73 m2; IgAN with GFR < 15ml/min/1.73 m2; IgAN with glomerular filtration rate (GFR) >90 ml/min/1.73 m2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Glomerulonephritis, IGA

Interventions

Electrocardiography, Ambulatory

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Electrocardiography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Monitoring, Ambulatory; Monitoring, Physiologic

Study Officials

• Eric Alamartine, PhD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2015
• First Posted: August 19, 2015
• Study Start: January 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: August 19, 2015

Record last verified: 2015-08

Locations

FR (1)