Aliskiren and Muscle Sympathetic Nerve Activity (MSNA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by UMC Utrecht.
Recruitment status was  Recruiting
Information provided by:
UMC Utrecht Identifier:
First received: July 17, 2008
Last updated: January 13, 2010
Last verified: July 2008
The central hypothesis of this project is that Aliskiren causes a substantial decrease in MSNA in hypertensive patients with CKD.

Condition Intervention Phase
Chronic Kidney Disease
Muscle Sympathetic Nerve Activity
Drug: Aliskiren
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Aliskiren on Muscle Sympathetic Nerve Activity (MSNA) in Hypertensive Patients With Chronic Kidney Disease

Resource links provided by NLM:

Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • Normalisation of muscle sympathetic nerve activity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Blood pressure and Blood tests [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: July 2008
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Patients receive Aliskiren 300mg for 6 weeks
Drug: Aliskiren
Aliskiren 300mg per day for 6 weeks
Other Name: Rasilez 300mg per day
No Intervention: Group 2
4 weeks no antihypertensive medication

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.

Ages Eligible for Study:   25 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00719316

Contact: Laima Siddiqi, MD + 31 88 755 7329

University Medical Center utrecht Recruiting
Utrecht, Netherlands, 3584CX
Principal Investigator: Laima Siddiqi, MD         
Sponsors and Collaborators
UMC Utrecht
Principal Investigator: P. J. Blankestijn, MD, PhD UMC Utrecht
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr. P. J. Blankestijn, UMC Utrecht Identifier: NCT00719316     History of Changes
Other Study ID Numbers: NL19926.041.07 
Study First Received: July 17, 2008
Last Updated: January 13, 2010
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by UMC Utrecht:
Renin inhibitor
ACE inhibitor or ARB
Chronic Kidney Disease

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases processed this record on May 23, 2016