Efficacy and Safety of Aliskiren and Aliskiren/Enalapril Combination on Morbi-mortality in Patients With Chronic Heart Failure



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:March 2009
End Date:October 2015

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A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of Both Aliskiren Monotherapy and Aliskiren/Enalapril Combination Therapy Compared to Enalapril Monotherapy, on Morbidity and Mortality in Patients With Chronic Heart Failure (NYHA Class II - IV).

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

- Patients with diabetes mellitus

- Other protocol-defined inclusion/exclusion criteria may apply
We found this trial at
67
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Omaha, Nebraska 68144
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Athens, Georgia 30606
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Auburn, Maine 04210
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Augusta, Georgia 30904
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Bahia Blanca, Buenos Aires
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Beverly Hills, California 90211
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Boynton Beach, Florida 33437
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Charleston, South Carolina 29407
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Dallas, Texas 75216
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Daytona Beach, Florida 32117
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Denver, Colorado 80262
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Durham, North Carolina 27710
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Elmer, New Jersey 08318
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Everett, Washington 98208
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Fort Lauderdale, Florida 33313
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Fort Lauderdale, Florida 33313
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French Camp, California 95231
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Germantown, Tennessee 38138
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Gillespie, Illinois 62033
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Hollywood, Florida 33021
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Hot Springs, Arkansas 71913
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Houston, Texas 77030
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Houston, Texas 77030
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Houston, Texas 77030
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Huntsville, Alabama 35801
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Inglewood, California 90301
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Jacksonville Beach, Florida 32050
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Kirkland, Washington 98034
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Laurelton, New York 11422
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Lincoln, Nebraska 68506
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Little Rock, Arkansas 72204
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Little Rock, Arkansas 72204
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Little Rock, Arkansas 72204
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Little Rock, Arkansas 72204
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Littleton, Colorado 80120
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Los Angeles, California 90095
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Marion, Ohio 43302
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Memphis, Tennessee 38120
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Metairie, Louisiana 70006
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Miami Lakes, Florida 33014
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Mobile, Alabama 36693
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Mobile, Alabama 36693
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Mobile, Alabama 36693
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Modesto, California 95355
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Nashville, Tennessee 37205
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New Orleans, Louisiana 70115
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Northridge, California 91325
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Orlando, Florida 32806
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Pine Bluff, Arkansas 71603
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Sacramento, California 95825
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Santa Monica, California 90404
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Searcy, Arkansas 72143
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Slidell, Louisiana 70458
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Southfield, Michigan 48075
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St. Louis, Missouri 63110
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Stony Brook, New York 11794
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Topeka, Kansas 66606
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Tucson, Arizona 85745
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Varnville, South Carolina 29944
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Wellington, Florida 33449
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Westlake Village, California 91361
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