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| Sponsored by: |
UMC Utrecht |
|---|---|
| Information provided by: | UMC Utrecht |
| ClinicalTrials.gov Identifier: | NCT00719316 |
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 IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Placebo Control, Crossover Assignment, Efficacy Study |
| Official Title: | Effect of Aliskiren on Muscle Sympathetic Nerve Activity (MSNA) in Hypertensive Patients With Chronic Kidney Disease |
| Estimated Enrollment: | 25 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | January 2010 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Group 1: Experimental
Patients receive Aliskiren 300mg for 6 weeks
|
Drug: Aliskiren
Aliskiren 300mg per day for 6 weeks
|
|
Group 2: No Intervention
4 weeks no antihypertensive medication
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: L. Siddiqi, MD | + 31 88 755 7329 | l.siddiqi@umcutrecht.nl |
| Netherlands | |
| University Medical Center utrecht | |
| Utrecht, Netherlands, 3584CX | |
| Principal Investigator: | P. J. Blankestijn, MD, PhD | University medical Center Utrecht |
More Information
| Responsible Party: | UMC Utrecht ( Dr. P. J. Blankestijn ) |
| Study ID Numbers: | NL19926.041.07 |
| Study First Received: | July 17, 2008 |
| Last Updated: | July 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00719316 History of Changes |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
|
Renin inhibitor Patients ACE inhibitor or ARB Chronic Kidney Disease Hypertension |
|
Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic Vascular Diseases Kidney Failure, Chronic |
Angiotensin-Converting Enzyme Inhibitors Kidney Diseases Kidney Failure Hypertension |
|
Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic Vascular Diseases Kidney Failure, Chronic |
Cardiovascular Diseases Kidney Diseases Kidney Failure Hypertension |
