RAAS Inhibitor Drugs in Dialysis Patients

University of Campania "Luigi Vanvitelli"

Status and phase: Unknown; Phase 4

Conditions: Hypertension; End Stage Renal Disease

Treatments: Drug: aliskiren

Study type: Interventional

Funder types: Other

Identifiers

NCT01635387

RAAS-block dial

Details and patient eligibility

About

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.

Enrollment: 350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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350 participants in 2 patient groups, including a placebo group

Aliskiren

Experimental group

Treatment:

Drug: aliskiren

Placebo

Placebo Comparator group

Treatment:

Drug: aliskiren