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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

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

25 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

NCT ID

NCT00719316

First Posted

July 17, 2008

Last Updated

January 13, 2010

Sponsor

UMC Utrecht

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

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

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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