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Aliskiren or Amlodipine in Hypertensive Hemodialysed Patients

Primary Purpose

Hypertension, Dialysis

Status
Unknown status
Phase
Phase 4
Locations
Italy
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 focused on measuring hypertension, dialysis, aliskiren, amlodipine, outcome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • hemodialysed patients
  • predialytic blood pressure greater or equal to 140/90 mmHg

Exclusion Criteria:

  • history of heart failure
  • history of ischemic heart disease
  • severe aortic stenosis
  • known allergy to aliskiren or amlodipine
  • severe disorders of liver function

Sites / Locations

  • Second Univesity of Naples

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aliskiren

Amlodipine

Arm Description

Outcomes

Primary Outcome Measures

composite end-point of: all-cause mortality; cardiac event including myocardial infarction, need for coronary angioplasty or coronary bypass surgery, ischaemic stroke

Secondary Outcome Measures

composite end-point of: all-cause hospitalization, new-onset heart failure,new-onset atrial fibrillation

Full Information

First Posted
July 13, 2011
Last Updated
July 9, 2012
Sponsor
University of Campania "Luigi Vanvitelli"
Collaborators
IRCCS San Raffaele
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1. Study Identification

Unique Protocol Identification Number
NCT01394770
Brief Title
Aliskiren or Amlodipine in Hypertensive Hemodialysed Patients
Official Title
Cardiovascular Events in Hypertensive Hemodialysed Patients: Aliskiren Versus Amlodipine. A Randomized, Double-blind Study.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (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 aliskiren, a direct renin inhibitor, compared with amlodipine, a calcium channel blocker, reduces mortality and cardiovascular events in these high-risk patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Dialysis
Keywords
hypertension, dialysis, aliskiren, amlodipine, outcome

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Aliskiren
Arm Type
Experimental
Arm Title
Amlodipine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Aliskiren
Other Intervention Name(s)
Rasilez, Norvasc
Intervention Description
Aliskiren 150 mg for 1 month with forced uptitration to 300 mg compared in parallel group with amlodipine 5 mg with forced uptitration to 10 mg
Primary Outcome Measure Information:
Title
composite end-point of: all-cause mortality; cardiac event including myocardial infarction, need for coronary angioplasty or coronary bypass surgery, ischaemic stroke
Time Frame
30 months
Secondary Outcome Measure Information:
Title
composite end-point of: all-cause hospitalization, new-onset heart failure,new-onset atrial fibrillation
Time Frame
30 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: hemodialysed patients predialytic blood pressure greater or equal to 140/90 mmHg Exclusion Criteria: history of heart failure history of ischemic heart disease severe aortic stenosis known allergy to aliskiren or amlodipine severe disorders of liver function
Facility Information:
Facility Name
Second Univesity of Naples
City
Naples
ZIP/Postal Code
80100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
33000470
Citation
Mugendi GA, Mutua FM, Natale P, Esterhuizen TM, Strippoli GF. Calcium channel blockers for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2020 Oct 1;10(10):CD011064. doi: 10.1002/14651858.CD011064.pub2.
Results Reference
derived

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Aliskiren or Amlodipine in Hypertensive Hemodialysed Patients

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