Sympathetic Nerve Activity in Renal Failure

NCT ID: NCT00892892

Last Updated: 2015-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Kidney Disease Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm 1

Rilmenidine as a sympatholytic agent for three months

Group Type EXPERIMENTAL

Rilmenidine

Intervention Type DRUG

1 mg Rilmenidine per day versus

Arm 2

Nitrendipine as a non-sympatholytic agent for three months

Group Type ACTIVE_COMPARATOR

Nitrendipine

Intervention Type DRUG

20 mg Nitrendipine per day

Interventions

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Rilmenidine

1 mg Rilmenidine per day versus

Intervention Type DRUG

Nitrendipine

20 mg Nitrendipine per day

Intervention Type DRUG

Other Intervention Names

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Hyperium Bayotensin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roland E Schmieder, MD

Role: PRINCIPAL_INVESTIGATOR

University of Erlangen-Nurnberg

Locations

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University of Erlangen-Nuremberg, CRC, med. Clinic 4

Erlangen, Bavaria, Germany

Site Status

Countries

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Germany

Other Identifiers

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Re-No. 3186

Identifier Type: -

Identifier Source: org_study_id

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