Safety and Efficacy Study of Add On Aliskiren in Patients With Heart Failure and Renal Impairment

• Status: Terminated
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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 reduced renal function.

• Primary outcome measure: change in renal blood flow at 6 months

• Secondary outcome measures: changes in renal function, N-terminal pro Brain natriuretic peptide, left ventricular function, blood pressure and neurohormones

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Medical Center Groningen

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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