Aliskiren and Muscle Sympathetic Nerve Activity

Phase 4

• Conditions: Chronic Kidney Disease; Hypertension; Muscle Sympathetic Nerve Activity
• Interventions: Drug: Aliskiren

• Registration Number: NCT00719316
• Lead Sponsor: UMC Utrecht

Brief Summary

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

Detailed Description

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.

Study Timeline

• Status Verified: 2008-07
• Study Start: 2008-07
• Study First Submitted: 2008-07-17
• Study First Submitted QC: 2008-07-18
• Study First Posted: 2008-07-21
• Primary Completion: 2009-07
• Study Completion: 2010-01
• Last Update Submitted: 2010-01-13
• Last Update Posted: 2010-01-14

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 1	Aliskiren	Patients receive Aliskiren 300mg for 6 weeks

Primary Outcome Measures

Name	Time	Method
Normalisation of muscle sympathetic nerve activity	1 year

Secondary Outcome Measures

Name	Time	Method
Blood pressure and Blood tests	1 year

Trial Locations

Locations (1)

University Medical Center utrecht; 🇳🇱 Utrecht, Netherlands