RAAS Inhibitor Drugs in Dialysis Patients

Hypertension Clinical Trial

Official title:

Upstream Use of Aliskiren in Hypertensive Haemodialysis Patients: Effects on Cardiovascular Outcomes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01635387
• Other study ID #: RAAS-block dial
• Status: Active, not recruiting
• Phase: Phase 4
• First received: June 27, 2012
• Last updated: July 4, 2012
• Start date: February 2010
• Est. completion date: September 2012

Study information

• Verified date: July 2012
• Source: Second University of Naples
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 350
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Disease
• Hypertension
• Kidney Failure, Chronic

Intervention

Drug:
• aliskiren
150 mg once a day per 2 week with forced uptitration to 300 mg once a day, if tolerated

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Second University of Naples	IRCCS San Raffaele

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No