Aliskiren or Amlodipine in Hypertensive Hemodialysed Patients

University of Campania Luigi Vanvitelli350 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

350

Conditions

Hypertension Dialysis

Interventions

AliskirenDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Second Univesity of Naples

Naples, Italy

Outcomes

Primary Outcomes

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 Outcomes

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

Time frame: 30 months

Data from ClinicalTrials.gov

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