End Stage Renal Disease, Hypertension
Conditions
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.
Interventions
DRUGaliskiren
150 mg once a day per 2 week with forced uptitration to 300 mg once a day, if tolerated
Sponsors
IRCCS San Raffaele
University of Campania Luigi Vanvitelli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Outcome results
None listed