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

Use our guide to learn which trials are right for you!

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
sites
Augusta, Georgia 30904
853
mi
from 02139
Augusta, GA
Click here to add this to my saved trials
Athens, Georgia 30606
885
mi
from 02139
Athens, GA
Click here to add this to my saved trials
Auburn, Maine 04210
127
mi
from 02139
Auburn, ME
Click here to add this to my saved trials
Bahia Blanca, Buenos Aires
5629
mi
from 02139
Bahia Blanca,
Click here to add this to my saved trials
Beverly Hills, California 90211
2595
mi
from 02139
Beverly Hills, CA
Click here to add this to my saved trials
Boynton Beach, Florida 33437
1208
mi
from 02139
Boynton Beach, FL
Click here to add this to my saved trials
Charleston, South Carolina 29407
818
mi
from 02139
Charleston, SC
Click here to add this to my saved trials
Dallas, Texas 75216
1549
mi
from 02139
Dallas, TX
Click here to add this to my saved trials
Daytona Beach, Florida 32117
1063
mi
from 02139
Daytona Beach, FL
Click here to add this to my saved trials
Denver, Colorado 80262
1760
mi
from 02139
Denver, CO
Click here to add this to my saved trials
Durham, North Carolina 27710
607
mi
from 02139
Durham, NC
Click here to add this to my saved trials
Elmer, New Jersey 08318
285
mi
from 02139
Elmer, NJ
Click here to add this to my saved trials
Everett, Washington 98208
2472
mi
from 02139
Everett, WA
Click here to add this to my saved trials
Fort Lauderdale, Florida 33313
1233
mi
from 02139
Fort Lauderdale, FL
Click here to add this to my saved trials
Fort Lauderdale, Florida 33313
1233
mi
from 02139
Fort Lauderdale, FL
Click here to add this to my saved trials
French Camp, California 95231
2629
mi
from 02139
French Camp, CA
Click here to add this to my saved trials
Germantown, Tennessee 38138
1122
mi
from 02139
Germantown, TN
Click here to add this to my saved trials
Gillespie, Illinois 62033
1002
mi
from 02139
Gillespie, IL
Click here to add this to my saved trials
Hollywood, Florida 33021
1240
mi
from 02139
Hollywood, FL
Click here to add this to my saved trials
Hot Springs, Arkansas 71913
1301
mi
from 02139
Hot Springs, AR
Click here to add this to my saved trials
Houston, Texas 77030
1605
mi
from 02139
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77030
1605
mi
from 02139
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77030
1605
mi
from 02139
Houston, TX
Click here to add this to my saved trials
Huntsville, Alabama 35801
984
mi
from 02139
Huntsville, AL
Click here to add this to my saved trials
Inglewood, California 90301
2596
mi
from 02139
Inglewood, CA
Click here to add this to my saved trials
Jacksonville Beach, Florida 32050
1037
mi
from 02139
Jacksonville Beach, FL
Click here to add this to my saved trials
Kirkland, Washington 98034
2475
mi
from 02139
Kirkland, WA
Click here to add this to my saved trials
Laurelton, New York 11422
179
mi
from 02139
Laurelton, NY
Click here to add this to my saved trials
Lincoln, Nebraska 68506
1319
mi
from 02139
Lincoln, NE
Click here to add this to my saved trials
Little Rock, Arkansas 72204
1260
mi
from 02139
Little Rock, AR
Click here to add this to my saved trials
Little Rock, Arkansas 72204
1260
mi
from 02139
Little Rock, AR
Click here to add this to my saved trials
Little Rock, Arkansas 72204
1260
mi
from 02139
Little Rock, AR
Click here to add this to my saved trials
Little Rock, Arkansas 72204
1260
mi
from 02139
Little Rock, AR
Click here to add this to my saved trials
Littleton, Colorado 80120
1766
mi
from 02139
Littleton, CO
Click here to add this to my saved trials
Los Angeles, California 90095
2599
mi
from 02139
Los Angeles, CA
Click here to add this to my saved trials
Marion, Ohio 43302
633
mi
from 02139
Marion, OH
Click here to add this to my saved trials
Memphis, Tennessee 38120
1124
mi
from 02139
Memphis, TN
Click here to add this to my saved trials
Metairie, Louisiana 70006
1356
mi
from 02139
Metairie, LA
Click here to add this to my saved trials
Miami Lakes, Florida 33014
1251
mi
from 02139
Miami Lakes, FL
Click here to add this to my saved trials
Mobile, Alabama 36693
1242
mi
from 02139
Mobile, AL
Click here to add this to my saved trials
Mobile, Alabama 36693
1242
mi
from 02139
Mobile, AL
Click here to add this to my saved trials
Mobile, Alabama 36693
1242
mi
from 02139
Mobile, AL
Click here to add this to my saved trials
Modesto, California 95355
2622
mi
from 02139
Modesto, CA
Click here to add this to my saved trials
Nashville, Tennessee 37205
946
mi
from 02139
Nashville, TN
Click here to add this to my saved trials
Nashville, Tennessee 37205
946
mi
from 02139
Nashville, TN
Click here to add this to my saved trials
New Orleans, Louisiana 70115
1356
mi
from 02139
New Orleans, LA
Click here to add this to my saved trials
Northridge, California 91325
2596
mi
from 02139
Northridge, CA
Click here to add this to my saved trials
Omaha, Nebraska 68144
1285
mi
from 02139
Omaha, NE
Click here to add this to my saved trials
Orlando, Florida 32806
1115
mi
from 02139
Orlando, FL
Click here to add this to my saved trials
Orlando, Florida 32806
1115
mi
from 02139
Orlando, FL
Click here to add this to my saved trials
Pine Bluff, Arkansas 71603
1260
mi
from 02139
Pine Bluff, AR
Click here to add this to my saved trials
Sacramento, California 95825
2617
mi
from 02139
Sacramento, CA
Click here to add this to my saved trials
San Diego, California 92123
2571
mi
from 02139
San Diego, CA
Click here to add this to my saved trials
Santa Monica, California 90404
2600
mi
from 02139
Santa Monica, CA
Click here to add this to my saved trials
Searcy, Arkansas 72143
1210
mi
from 02139
Searcy, AR
Click here to add this to my saved trials
Searcy, Arkansas 72143
1210
mi
from 02139
Searcy, AR
Click here to add this to my saved trials
Slidell, Louisiana 70458
1328
mi
from 02139
Slidell, LA
Click here to add this to my saved trials
Southfield, Michigan 48075
618
mi
from 02139
Southfield, MI
Click here to add this to my saved trials
St. Louis, Missouri 63110
1036
mi
from 02139
St. Louis, MO
Click here to add this to my saved trials
Stony Brook, New York 11794
144
mi
from 02139
Stony Brook, NY
Click here to add this to my saved trials
Topeka, Kansas 66606
1304
mi
from 02139
Topeka, KS
Click here to add this to my saved trials
Tucson, Arizona 85745
2283
mi
from 02139
Tucson, AZ
Click here to add this to my saved trials
Tucson, Arizona 85745
2283
mi
from 02139
Tucson, AZ
Click here to add this to my saved trials
Varnville, South Carolina 29944
853
mi
from 02139
Varnville, SC
Click here to add this to my saved trials
Wellington, Florida 33449
1205
mi
from 02139
Wellington, FL
Click here to add this to my saved trials
Westlake Village, California 91361
2614
mi
from 02139
Westlake Village, CA
Click here to add this to my saved trials
Wiliamsville, New York 14221
388
mi
from 02139
Wiliamsville, NY
Click here to add this to my saved trials