RAAS Inhibitor Drugs in Dialysis Patients

Phase 4

• Conditions: Hypertension; End Stage Renal Disease
• Interventions: Drug: aliskiren

• Registration Number: NCT01635387
• Lead Sponsor: University of Campania "Luigi Vanvitelli"

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2012-06-27
• Status Verified: 2012-07
• Study First Submitted QC: 2012-07-04
• Last Update Submitted: 2012-07-04
• Study First Posted: 2012-07-09
• Last Update Posted: 2012-07-09
• Primary Completion: 2012-09
• Study Completion: 2012-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aliskiren	aliskiren	-
Placebo	aliskiren	-

Primary Outcome Measures

Name	Time	Method
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)	30 months