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

University of Campania "Luigi Vanvitelli"0 sites350 target enrollmentFebruary 2010

ConditionsHypertension End Stage Renal Disease

Interventionsaliskiren

Drugsaliskiren

Overview

Phase: Phase 4
Intervention: aliskiren
Conditions: Hypertension
Sponsor: University of Campania "Luigi Vanvitelli"
Enrollment: 350
Primary Endpoint: 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)
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2010

End Date

September 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Campania "Luigi Vanvitelli"

Responsible Party

Principal Investigator

Gennaro Cice

University of Campania "Luigi Vanvitelli"

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

Arms & Interventions

Aliskiren

Intervention: aliskiren

Placebo

Intervention: aliskiren

Outcomes

Primary Outcomes

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