This trial is active, not recruiting.

Conditions hypertension, end stage renal disease
Treatment aliskiren
Phase phase 4
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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
150 mg once a day per 2 week with forced uptitration to 300 mg once a day, if tolerated
(Placebo Comparator)
150 mg once a day per 2 week with forced uptitration to 300 mg once a day, if tolerated

Primary Outcomes

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

Eligibility Criteria

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

Additional Information

Official title Upstream Use of Aliskiren in Hypertensive Haemodialysis Patients: Effects on Cardiovascular Outcomes
Trial information was received from ClinicalTrials.gov and was last updated in July 2012.
Information provided to ClinicalTrials.gov by Second University of Naples.