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RAAS Inhibitor Drugs in Dialysis Patients

Primary Purpose

Hypertension, End Stage Renal Disease

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
aliskiren
Sponsored by
University of Campania "Luigi Vanvitelli"
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Aliskiren

    Placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    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)

    Secondary Outcome Measures

    Full Information

    First Posted
    June 27, 2012
    Last Updated
    July 4, 2012
    Sponsor
    University of Campania "Luigi Vanvitelli"
    Collaborators
    IRCCS San Raffaele
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01635387
    Brief Title
    RAAS Inhibitor Drugs in Dialysis Patients
    Official Title
    Upstream Use of Aliskiren in Hypertensive Haemodialysis Patients: Effects on Cardiovascular Outcomes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2012
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2010 (undefined)
    Primary Completion Date
    September 2012 (Anticipated)
    Study Completion Date
    September 2012 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Campania "Luigi Vanvitelli"
    Collaborators
    IRCCS San Raffaele

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertension, End Stage Renal Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    350 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Aliskiren
    Arm Type
    Experimental
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    aliskiren
    Intervention Description
    150 mg once a day per 2 week with forced uptitration to 300 mg once a day, if tolerated
    Primary Outcome Measure Information:
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

    RAAS Inhibitor Drugs in Dialysis Patients

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