Status:
TERMINATED
Safety and Efficacy Study of Add On Aliskiren in Patients With Heart Failure and Renal Impairment
Lead Sponsor:
University Medical Center Groningen
Conditions:
Heart Failure
Kidney Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The main purpose of this study is to examine the effect of add-on therapy with the direct renin inhibitor Aliskiren in comparison to placebo on renal blood flow in patients with heart failure and redu...
Detailed Description
This study is a randomized, double-blind, placebo controlled, parallel group comparison trial, enrolling 100 patients (67 vs. 33) with stable CHF. Patients will be randomized to Aliskiren 300 mg once ...
Eligibility Criteria
Inclusion
- NYHA II-IV Heart Failure
- Left ventricular ejection fraction \< 45%
- Stable heart failure medication
- eGFR by sMDRD formula between 30 and 60 mL/min/1.73m2
Exclusion
- Known hypersensitivity to study drug or ACEi
- Concomitant treatment with both ARB and Aldosterone Receptor Antagonist
- Symptomatic Hypotension
- Acute Heart Failure
- History of stroke, acute coronary syndrome, PCI or angioplasty within past 3 months
- Serum potassium \> 5.2 mmol/L
- Right heart failure due to severe pulmonary disease
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00881439
Start Date
April 1 2009
End Date
December 1 2012
Last Update
May 17 2013
Active Locations (1)
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1
University Medical Center Groningen
Groningen, Netherlands