The study will evaluate the efficacy and safety of both aliskiren monotherapy and
aliskiren/enalapril combination therapy as compared to enalapril monotherapy, on morbidity
and mortality in patients with chronic heart failure (NYHA Class II - IV.
Inclusion Criteria:
- Patients with a diagnosis of chronic heart failure (NYHA Class II - IV):
- LVEF ≤ 35% at visit 1. (local measurement, measured within the past 6 months
assessed by echocardiogram, MUGA, CT scan, MRI or ventricular angiography)
- Elevated BNP at visit 1: BNP ≥ 150 pg/ml (according to local measurement).
- BNP ≥ 100 pg/ml (according to local measurement) and unplanned hospitalization
with HF within the last 12 months prior visit 1.
- Patients must be treated with an ACE inhibitor at a stable dose (enalapril 10 mg
daily at least or any other ACE inhibitor, e. g. ramipril, quinapril, lisinopril,
fosinopril, perindopril, trandolapril; based on equivalent doses as described in the
dose equivalence guidance table of ACEi's) for at least 4 weeks prior to visit 1
Exclusion Criteria:
- History of hypersensitivity to any of the study drugs including history or allergy to
ACEi's as well as known or suspected contraindications to the study drugs or previous
history of intolerance to high doses of ACEi's during up titration process.
- Patients treated concomitantly with both ARB and aldosterone antagonist in addition
to study drug at visit 1.
- Current acute decompensated HF.
- Symptomatic hypotension and/or less than 95 mmHg SBP at visit 1 and/or less than 90
mmHg at visit 4.
- Renal disease likely to be life threatening or eGFR < 40 ml/min/1. 73m2 as measured by
the MDRD formula at visit 1 and eGFR < 35 ml/min/1. 73m2 as measured by the MDRD
formula at visit 4 or decrease of eGFR of more than 25% from visit 1 to visit 4
(according to local laboratory measurement).
- Serum potassium ≥ 5. 0 mmol/L at visit 1 or ≥ 5. 2 mmol/L at visit 4 (according to
local laboratory measurement).
- Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or major
vascular surgery, percutaneous coronary intervention (PCI) or carotid angioplasty,
within the past 3 months prior to visit 1.
- Coronary or carotid artery disease likely to require surgical or percutaneous
intervention within the 6 months after visit 1.
- Right heart failure due to severe pulmonary disease
- Other protocol-defined inclusion/exclusion criteria may apply
Investigative Site, Buenos Aires, Argentina; Recruiting
Novartis, Phone: 862-778-8300
Investigative Site, Sydney, Australia; Recruiting
Novartis, Phone: 862-778-8300
Investigative Site, Brussels, Belgium; Recruiting
Novartis, Phone: 862-778-8300
Investigative Site, Toronto, Canada; Recruiting
Novartis, Phone: 862-778-8300
Investigative Site, Beijing, China; Recruiting
Novartis, Phone: 862-778-8300
Investigative Site, Bogota, Colombia; Recruiting
Novartis, Phone: 862-778-8300
Investigative Site, San Jose, Costa Rica; Recruiting
Novartis, Phone: 862-778-8300
Investigative Site, Prague, Czech Republic; Recruiting
Novartis, Phone: 862-778-8300
Investigative Site, Copenhagen, Denmark; Recruiting
Novartis, Phone: 862-778-8300
Investigative Site, Tallinn, Estonia; Recruiting
Novartis, Phone: 862-778-8300
Investigative Site, Helsinki, Finland; Recruiting
Novartis, Phone: 862-778-8300
Investigative Site, Paris, France; Recruiting
Novartis, Phone: 862-778-8300
Investigative Site, Berlin, Germany; Recruiting
Novartis\, Phone: 862-778-8300
Investigative Site, Athens, Greece; Recruiting
Novartis, Phone: 862-778-8300
Investigative Site, Budapest, Hungary; Recruiting
Novartis, Phone: 862-778-8300
Investigative Site, Reykjavik, Iceland; Recruiting
Novartis, Phone: 862-778-8300
Investigative Site, New Dehli, India; Recruiting
Novartis, Phone: 862-778-8300
Investigative Site, Dublin, Ireland; Recruiting
Novartis, Phone: 862-778-8300
Investigative Site, Rome, Italy; Recruiting
Novartis, Phone: 862-778-8900
Investigative Site, Tokyo, Japan; Recruiting
Novartis, Phone: 862-778-8900
Investigative Site, Seoul, Korea, Republic of; Recruiting
Novartis, Phone: 862-778-8900
Investigative Site, Kivea, Latvia; Recruiting
Novartis, Phone: 862-778-8300
Investigative Site, Vilnius, Lithuania; Recruiting
Novartis, Phone: 862-778-8300
Investigative Site, Amsterdam, Netherlands; Recruiting
Novartis, Phone: 862-778-8300
Investigative Site, Oslo, Norway; Recruiting
Novartis, Phone: 862-778-8300
Investigative Site, Lima, Peru; Recruiting
Norvartis, Phone: 862-778-8300
Investigative Site, Warsaw, Poland; Recruiting
Novartis, Phone: 862-778-8300
Investigative Site, Lisbon, Portugal; Recruiting
Novartis, Phone: 862-778-8300
Investigative Site, Bucharest, Romania; Recruiting
Novartis, Phone: 862-778-8300
Investigative Site, Moscow, Russian Federation; Recruiting
Novartis, Phone: 862-778-8300
Investigative Site, Bratislava, Slovakia; Recruiting
Novartis, Phone: 862-778-8300
Investigative Site, Transvaal, South Africa; Recruiting
Novartis, Phone: 862-778-8300
Investigative Site, Madrid, Spain; Recruiting
Novartis, Phone: 862-778-8300
Investigative Site, Stockholm, Sweden; Recruiting
Novartis, Phone: 862-778-8300
Investigative Site, Geneva, Switzerland; Recruiting
Novartis, Phone: 862-778-8300
Investigative Site, Taipei, Taiwan; Recruiting
Novartis, Phone: 862-778-8300
Investigative Site, Bangkok, Thailand; Recruiting
Novartis, Phone: 862-778-8300
Investigative Site, Ankara, Turkey; Recruiting
Novartis, Phone: 862-778-8300
Investigative Site, London, United Kingdom; Recruiting
Novartis, Phone: 862-778-8300
Investigative Site, Carockis, Venezuela; Recruiting
Novartis, Phone: 862-778-8300
Investigative Site, Detroit, Michigan, United States; Recruiting
Novartis, Phone: 862-778-8300
