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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02527902
Other study ID # 1008123
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Completed NCT00004448 - Alternate Day Prednisone or Daily Fish Oil Supplements in Patients With Immunoglobulin A Nephropathy Phase 2
Completed NCT01560052 - Therapeutic Evaluation of Steroids in IgA Nephropathy Global Study (TESTING Low Dose Study) N/A
Completed NCT00006137 - Pilot Study of Enalapril and Renal Function in Patients With IgA Nephropathy N/A
Completed NCT00004305 - Study of Genetic Anomalies of Complement Related Proteins in Patients With IgA Glomerulonephritis N/A
Completed NCT01115426 - Inhibitors of Angiotensin II in Proteinuric Mesangioproliferative Glomerulonephritis Phase 4