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

IGA Glomerulonephritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02527902
• Other study ID #: 1008123
• Status: Completed
• Phase: N/A
• First received: August 18, 2015
• Last updated: August 18, 2015
• Start date: January 2011
• Est. completion date: April 2012

Study information

• Verified date: August 2015
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Glomerulonephritis
• Glomerulonephritis, IGA
• IGA Glomerulonephritis

Intervention

Device:
• Holter
measure of ANS in IgAN patients

Locations

Country	Name	City	State
France	CHU Saint-Etienne	Saint-Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No