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Aliskiren and Muscle Sympathetic Nerve Activity (MSNA)

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ClinicalTrials.gov Identifier: NCT00719316
Recruitment Status : Unknown
Verified July 2008 by UMC Utrecht.
Recruitment status was:  Recruiting
First Posted : July 21, 2008
Last Update Posted : January 14, 2010
Sponsor:
Information provided by:
UMC Utrecht

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

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Hypertension Muscle Sympathetic Nerve Activity Drug: Aliskiren Phase 4

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Aliskiren on Muscle Sympathetic Nerve Activity (MSNA) in Hypertensive Patients With Chronic Kidney Disease
Study Start Date : July 2008
Estimated Primary Completion Date : July 2009
Estimated Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Aliskiren
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Normalisation of muscle sympathetic nerve activity [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Blood pressure and Blood tests [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00719316


Contacts
Contact: Laima Siddiqi, MD + 31 88 755 7329 l.siddiqi@umcutrecht.nl

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. P. J. Blankestijn, UMC Utrecht
ClinicalTrials.gov Identifier: NCT00719316     History of Changes
Other Study ID Numbers: NL19926.041.07
First Posted: July 21, 2008    Key Record Dates
Last Update Posted: January 14, 2010
Last Verified: July 2008

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

Additional relevant MeSH terms:
Hypertension
Kidney Diseases
Renal Insufficiency, Chronic
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency