RAAS Inhibitor Drugs in Dialysis Patients
This trial is active, not recruiting.
|Conditions||hypertension, end stage renal disease|
|Sponsor||Second University of Naples|
|Collaborator||IRCCS San Raffaele|
|Start date||February 2010|
|End date||September 2012|
|Trial size||350 participants|
|Trial identifier||NCT01635387, RAAS-block dial|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator)|
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
Male or female participants at least 18 years old.
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
|Official title||Upstream Use of Aliskiren in Hypertensive Haemodialysis Patients: Effects on Cardiovascular Outcomes|
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