Aliskiren and Muscle Sympathetic Nerve Activity (MSNA)
Primary Purpose
Chronic Kidney Disease, Hypertension, Muscle Sympathetic Nerve Activity
Status
Unknown status
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Aliskiren
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Renin inhibitor, Patients, ACE inhibitor or ARB, Chronic Kidney Disease, Hypertension
Eligibility 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
Sites / Locations
- University Medical Center utrechtRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Group 1
Group 2
Arm Description
Patients receive Aliskiren 300mg for 6 weeks
4 weeks no antihypertensive medication
Outcomes
Primary Outcome Measures
Normalisation of muscle sympathetic nerve activity
Secondary Outcome Measures
Blood pressure and Blood tests
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00719316
Brief Title
Aliskiren and Muscle Sympathetic Nerve Activity
Acronym
MSNA
Official Title
Effect of Aliskiren on Muscle Sympathetic Nerve Activity (MSNA) in Hypertensive Patients With Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Unknown status
Study Start Date
July 2008 (undefined)
Primary Completion Date
July 2009 (Anticipated)
Study Completion Date
January 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
UMC Utrecht
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Hypertension, Muscle Sympathetic Nerve Activity
Keywords
Renin inhibitor, Patients, ACE inhibitor or ARB, Chronic Kidney Disease, Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Patients receive Aliskiren 300mg for 6 weeks
Arm Title
Group 2
Arm Type
No Intervention
Arm Description
4 weeks no antihypertensive medication
Intervention Type
Drug
Intervention Name(s)
Aliskiren
Other Intervention Name(s)
Rasilez 300mg per day
Intervention Description
Aliskiren 300mg per day for 6 weeks
Primary Outcome Measure Information:
Title
Normalisation of muscle sympathetic nerve activity
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Blood pressure and Blood tests
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laima Siddiqi, MD
Phone
+ 31 88 755 7329
Email
l.siddiqi@umcutrecht.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
P. J. Blankestijn, MD, PhD
Organizational Affiliation
UMC Utrecht
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center utrecht
City
Utrecht
ZIP/Postal Code
3584CX
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laima Siddiqi, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
21467128
Citation
Siddiqi L, Oey PL, Blankestijn PJ. Aliskiren reduces sympathetic nerve activity and blood pressure in chronic kidney disease patients. Nephrol Dial Transplant. 2011 Sep;26(9):2930-4. doi: 10.1093/ndt/gfq857. Epub 2011 Apr 5.
Results Reference
derived
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Aliskiren and Muscle Sympathetic Nerve Activity
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