RAAS Inhibitor Drugs in Dialysis Patients

July 4, 2012 updated by: Gennaro Cice, University of Campania "Luigi Vanvitelli"

Upstream Use of Aliskiren in Hypertensive Haemodialysis Patients: Effects on Cardiovascular Outcomes

Hypertensive haemodialysis patients are at high risk for cardiovascular events. This study was undertaken to ascertain whether the upstream of aliskirne, a direct renin inhibitor improves mortality and cardiovascular outcomes in these high-risk population.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

350

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • chronic kidney disease stage 5
  • undergoing maintenance haemodialysis for a minimum of 3 months
  • existing arterial hypertension or
  • history of arterial hypertension or
  • resting blood pressure ≥140/90 mmHg or
  • antihypertensive medication
  • man and female
  • 18 years and older.

Exclusion Criteria:

  • recent myocardial infarction (less than 3 months)
  • atrial fibrillation/atrial flutter
  • hypotension with systolic blood pressure of <90 mmHg
  • high-grade aortic stenosis
  • left ventricular ejection fration <50%
  • known allergy to aliskiren
  • severe disorders of liver function

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: aliskiren
150 mg once a day per 2 week with forced uptitration to 300 mg once a day, if tolerated
Experimental: Aliskiren
Drug: aliskiren
150 mg once a day per 2 week with forced uptitration to 300 mg once a day, if tolerated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
time to first clinical event (among mortality from any cause, cardiac event including myocardial infarction, need for coronary angioplasty or coronary bypass surgery, ischaemic stroke, new-onset heart failure, new-onset atrial fibrillation)
Time Frame: 30 months
30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campania "Luigi Vanvitelli"

Collaborators

IRCCS San Raffaele

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Anticipated)

September 1, 2012

Study Completion (Anticipated)

September 1, 2012

Study Registration Dates

First Submitted

June 27, 2012

First Submitted That Met QC Criteria

July 4, 2012

First Posted (Estimate)

July 9, 2012

Study Record Updates

Last Update Posted (Estimate)

July 9, 2012

Last Update Submitted That Met QC Criteria

July 4, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RAAS-block dial

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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