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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
Sponsor:
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00719316
First received: July 17, 2008
Last updated: January 13, 2010
Last verified: July 2008
History of Changes
  Purpose

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
Hypertension
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:

Drug Information available for: Aliskiren
U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   25 Years to 95 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by UMC Utrecht

Additional 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
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
Patients
ACE inhibitor or ARB
Chronic Kidney Disease
Hypertension

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

ClinicalTrials.gov processed this record on May 23, 2013