Dialysis, Hypertension
Conditions
Keywords
hypertension, dialysis, aliskiren, amlodipine, outcome
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.
Interventions
DRUGAliskiren
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
Sponsors
IRCCS San Raffaele
University of Campania Luigi Vanvitelli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| composite end-point of: all-cause mortality; cardiac event including myocardial infarction, need for coronary angioplasty or coronary bypass surgery, ischaemic stroke | 30 months |
Secondary
| Measure | Time frame |
|---|---|
| composite end-point of: all-cause hospitalization, new-onset heart failure,new-onset atrial fibrillation | 30 months |
Countries
Italy
Outcome results
None listed