Aliskiren and Muscle Sympathetic Nerve Activity

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2010-01-31

Brief Summary

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The central hypothesis of this project is that Aliskiren causes a substantial decrease in MSNA in hypertensive patients with CKD.

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Detailed Description

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Cardiovascular (CV) morbidity and mortality are frequently occurring problems in chronic kidney disease (CKD) patients. Apart from the so called traditional risk factors, also risk factors more or less specific to CKD contribute in the pathogenesis of these problems. There is strong evidence that the sympathetic hyperactivity, which often characterizes CKD, is one such factor. Previously, we have shown that angiotensin converting enzyme inhibitors (ACEi) and angiotensin II receptor blockers (ARB) reduce but not normalize this sympathetic hyperactivity. We re-analysed the cohort of patients who were investigated in the past and subsequently treated according to present guidelines. The results show that, despite of treatment, the unfavourable relation between sympathetic hyperactivity and clinical outcome still exits. This might mean that treatment is insufficient. In present study, we want to study the effect of Aliskiren 300mg on sympathetic nerve activity.

Conditions

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Chronic Kidney Disease Hypertension Muscle Sympathetic Nerve Activity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1

Patients receive Aliskiren 300mg for 6 weeks

Group Type EXPERIMENTAL

Aliskiren

Intervention Type DRUG

Aliskiren 300mg per day for 6 weeks

Group 2

4 weeks no antihypertensive medication

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Aliskiren

Aliskiren 300mg per day for 6 weeks

Intervention Type DRUG

Other Intervention Names

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Rasilez 300mg per day

Eligibility Criteria

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Inclusion Criteria

* Patients with stable chronic kidney disease and hypertension: i.e. using antihypertensive drugs and/or blood pressure \> 145/90 mmHg when off medication.
* Patients on ACE inhibitor or ARB

Exclusion Criteria

* Patients with diabetes mellitus
* Patients on renal replacement therapy
* Pregnant patients Using of antihypertensive which cannot be stopped
* Patients on immunosuppressive therapy and active nephrotic syndrome

Minimum Eligible Age

25 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No