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NCT00892892 Clinical Trial

Sympathetic Nerve Activity in Renal Failure

Hypertension Clinical Trial

— SNS in CRF  

Official title:
Role of the Sympathetic Nerve System for the Pathogenesis and Progression of Chronic Kidney Failure

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00892892
Other study ID # Re-No. 3186
Secondary ID
Status Withdrawn
Phase Phase 4
First received May 1, 2009
Last updated March 16, 2015
Start date November 2009
Est. completion date June 2011

Study information
Verified date March 2015
Source University of Erlangen-Nürnberg Medical School
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

The primary purpose is to assess the role of sympathetic activation for the development and progression of chronic renal failure. Using microneurography sympathetic activity will be registered in various stages of kidney affection or failure and hypertension.

A sympatholytic agent will be compared with a non-sympatholytic drug to asses the effect sympathetic activation and on the progression of kidney disease.

The effects of a sympatholytic agent on cardiovascular reactivity to various stressors wil be examined.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- chronic renal failure stages I-IV

Exclusion Criteria:

- pregnancy and lactation

- severe heart failure or ischemic heart disease

- patients with NYHA III-IV

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Rilmenidine
1 mg Rilmenidine per day versus
• Nitrendipine
20 mg Nitrendipine per day

Locations
Country Name City State
Germany University of Erlangen-Nuremberg, CRC, med. Clinic 4 Erlangen Bavaria

Sponsors (1)
Lead Sponsor Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary sympathetic activation for the development and progression of chronic renal failure 3 months No
Secondary effects of a sympatholytic agent on cardiovascular reactivity to various stressors 3 months No
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