Comparison of Saocubitril/valsartaN Versus Enalapril on Effect on ntpRo-bnp in Patients Stabilized From an Acute Heart Failure Episode.



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:1/19/2019
Start Date:April 29, 2016
End Date:June 29, 2018

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

A Multicenter, Randomized, Double-blind, Double Dummy, Parallel Group, Active-controlled 8-week Study to Evaluate the Effect of Sacubitril/Valsartan (LCZ696) Versus Enalapril on Changes in NT-proBNP and Safety and Tolerability of In-hospital Initiation of LCZ696 Compared to Enalapril in HFrEF Patients Who Have Been Stabilized Following Hospitalization for Acute Decompensated Heart Failure (ADHF).

The purpose of this study is to assess the effect of in-hospital initiation of
sacubitril/valsartan (LCZ696) vs. enalapril on time averaged proportional change in NT-proBNP
in patients who have been stabilized following hospitalization for acute decompensated heart
failure (ADHF) and reduced ejection fraction (left ventricular ejection fraction (LVEF) ≤
40%).


Key Inclusion Criteria:

1. Possess the capacity to provide written informed consent which must be obtained before
any assessment is performed.

2. Currently hospitalized for ADHF. Patients with a diagnosis of acute heart failure had
to have symptoms and signs of fluid overload (i.e. jugular venous distention, edema or
rales on auscultation or pulmonary congestion on chest x-ray) at time of
hospitalization.

3. Eligible patients will be randomized no earlier than 24 hours and up to ten days after
presentation while still hospitalized as long as meet the following definition of
stable status:

- SBP ≥100mm Hg for the preceding 6 hours prior to randomization; no symptomatic
hypotension

- No increase (intensification) in i.v. diuretic dose within last 6 hours prior to
randomization

- No i.v. inotropic drugs for 24 hours prior to randomization

- No i.v. vasodilators including nitrates within last 6 hours prior to
randomization

4. LVEF ≤40% within the past 6 months (including current hospitalization) using
echocardiography, multi gated acquisition scan (MUGA), CT scanning, MRI or ventricular
angiography, provided no subsequent study documented an EF of >40%.

5. Elevated NT-proBNP ≥ 1600pg/mL OR BNP ≥400 pg/mL during current hospitalization.

Key Exclusion Criteria:

1. Currently taking sacubitril/valsartan tablets or any use within the past 30 days.

2. Enrollment in any other clinical trial involving an investigational agent or
investigational device.

3. History of hypersensitivity, known or suspected contraindications, or intolerance to
any of the study drugs, including ACEIs, ARBs, or Sacubitril (NEP inhibitor).

4. Patients with a known history of angioedema related to previous ACE inhibitor or ARB
therapy.

5. Requirement of treatment with both ACE inhibitor and ARB.

6. eGFR < 30 ml/min/1.73 m2 as measured by the simplified Modification of Diet in Renal
Disease (MDRD) formula at screening.

7. Serum potassium > 5.2 mEq/L at screening.

8. Known hepatic impairment (as evidenced by total bilirubin > 3 mg/dL, or increased
ammonia levels, if performed), or history of cirrhosis with evidence of portal
hypertension such as varices

9. Acute coronary syndrome, stroke, transient ischemic attack; cardiac, carotid or other
major CV surgery; percutaneous coronary intervention (PCI) or carotid angioplasty,
within one month prior to Visit 1.

10. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
female after conception and until the termination of gestation, confirmed by a
positive hCG laboratory test.

11. Women of child-bearing potential, defined as all women physiologically capable of
becoming pregnant, including women whose career, lifestyle, or sexual orientation
precludes intercourse with a male partner and women whose partners have been
sterilized by vasectomy or other means, UNLESS they are using two birth control
methods.
We found this trial at
112
sites
Elmer, New Jersey 08318
2376
mi
from 91732
Elmer, NJ
Click here to add this to my saved trials
Abington, Pennsylvania 19001
2376
mi
from 91732
Abington, PA
Click here to add this to my saved trials
Alexandria, Louisiana 71301
1494
mi
from 91732
Alexandria, LA
Click here to add this to my saved trials
Ann Arbor, Michigan 48109
1932
mi
from 91732
Ann Arbor, MI
Click here to add this to my saved trials
Annapolis, Maryland 21401
2309
mi
from 91732
Annapolis, MD
Click here to add this to my saved trials
Atlantis, Florida 33462
2305
mi
from 91732
Atlantis, FL
Click here to add this to my saved trials
Augusta, Georgia 30904
2057
mi
from 91732
Augusta, GA
Click here to add this to my saved trials
Aurora, Illinois 60504
1698
mi
from 91732
Aurora, IL
Click here to add this to my saved trials
Bakersfield, California 93301
107
mi
from 91732
Bakersfield, CA
Click here to add this to my saved trials
Baltimore, Maryland 21287
2302
mi
from 91732
Baltimore, MD
Click here to add this to my saved trials
Bangor, Maine 04401
2686
mi
from 91732
Bangor, ME
Click here to add this to my saved trials
Baton Rouge, Louisiana 70808
1585
mi
from 91732
Baton Rouge, LA
Click here to add this to my saved trials
Bay City, Michigan 48708
1934
mi
from 91732
Bay City, MI
Click here to add this to my saved trials
Birmingham, Alabama 35209
1785
mi
from 91732
Birmingham, AL
Click here to add this to my saved trials
Boise, Idaho 83712
665
mi
from 91732
Boise, ID
Click here to add this to my saved trials
Boston, Massachusetts 02118
2578
mi
from 91732
Boston, MA
Click here to add this to my saved trials
Bridgeport, Connecticut 06606
2472
mi
from 91732
Bridgeport, CT
Click here to add this to my saved trials
Bronx, New York 10461
2441
mi
from 91732
Bronx, NY
Click here to add this to my saved trials
Brooklyn, New York 11218
2434
mi
from 91732
Brooklyn, NY
Click here to add this to my saved trials
Buffalo, New York 14215
2184
mi
from 91732
Buffalo, NY
Click here to add this to my saved trials
Camden, New Jersey 08103
2377
mi
from 91732
Camden, NJ
Click here to add this to my saved trials
Camp Hill, Pennsylvania 17011
2281
mi
from 91732
Camp Hill, PA
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
2194
mi
from 91732
Chapel Hill, NC
Click here to add this to my saved trials
Charleston, South Carolina 29407
2184
mi
from 91732
Charleston, SC
Click here to add this to my saved trials
Charleston, West Virginia 25304
2035
mi
from 91732
Charleston, WV
Click here to add this to my saved trials
Charlottesville, Virginia 22904
2206
mi
from 91732
Charlottesville, VA
Click here to add this to my saved trials
Cincinnati, Ohio 45229
1881
mi
from 91732
Cincinnati, OH
Click here to add this to my saved trials
Clarksburg, West Virginia 26301
2102
mi
from 91732
Clarksburg, WV
Click here to add this to my saved trials
Dallas, Texas 75216
1225
mi
from 91732
Dallas, TX
Click here to add this to my saved trials
Daytona Beach, Florida 32117
2186
mi
from 91732
Daytona Beach, FL
Click here to add this to my saved trials
Denver, Colorado 80262
820
mi
from 91732
Denver, CO
Click here to add this to my saved trials
Des Moines, Iowa 50314
1422
mi
from 91732
Des Moines, IA
Click here to add this to my saved trials
Detroit, Michigan 48202
1965
mi
from 91732
Detroit, MI
Click here to add this to my saved trials
Elk Grove Village, Illinois 60007
1713
mi
from 91732
Elk Grove Village, IL
Click here to add this to my saved trials
Elkhart, Indiana 46514
1812
mi
from 91732
Elkhart, IN
Click here to add this to my saved trials
Fort Lauderdale, Florida 33313
2309
mi
from 91732
Fort Lauderdale, FL
Click here to add this to my saved trials
Fort Smith, Arkansas 72901
1340
mi
from 91732
Fort Smith, AR
Click here to add this to my saved trials
Fresno, California 93710
213
mi
from 91732
Fresno, CA
Click here to add this to my saved trials
Gainesville, Florida 32608
2104
mi
from 91732
Gainesville, FL
Click here to add this to my saved trials
Grand Forks, North Dakota 58201
1444
mi
from 91732
Grand Forks, ND
Click here to add this to my saved trials
Greenville, North Carolina 27834
2290
mi
from 91732
Greenville, NC
Click here to add this to my saved trials
Greenville, South Carolina 29605
2020
mi
from 91732
Greenville, SC
Click here to add this to my saved trials
Haddon Heights, New Jersey 08035
2381
mi
from 91732
Haddon Heights, NJ
Click here to add this to my saved trials
Hartford, Connecticut 06106
2497
mi
from 91732
Hartford, CT
Click here to add this to my saved trials
Hattiesburg, Mississippi 39401
1675
mi
from 91732
Hattiesburg, MS
Click here to add this to my saved trials
Hollywood, Florida 33021
2315
mi
from 91732
Hollywood, FL
Click here to add this to my saved trials
Houston, Texas 77030
1357
mi
from 91732
Houston, TX
Click here to add this to my saved trials
Indianapolis, Indiana 46202
1792
mi
from 91732
Indianapolis, IN
Click here to add this to my saved trials
Jackson, Mississippi 39209
1601
mi
from 91732
Jackson, MS
Click here to add this to my saved trials
Jacksonville, Florida 32216
2135
mi
from 91732
Jacksonville, FL
Click here to add this to my saved trials
Johnson City, New York 13790
2328
mi
from 91732
Johnson City, NY
Click here to add this to my saved trials
Kansas City, Kansas 66160
1339
mi
from 91732
Kansas City, KS
Click here to add this to my saved trials
Kansas City, Missouri 64111
1340
mi
from 91732
Kansas City, MO
Click here to add this to my saved trials
Lakeland, Florida 33805
2163
mi
from 91732
Lakeland, FL
Click here to add this to my saved trials
Little Rock, Arkansas 72204
1458
mi
from 91732
Little Rock, AR
Click here to add this to my saved trials
Littleton, Colorado 80120
813
mi
from 91732
Littleton, CO
Click here to add this to my saved trials
Long Beach, California 90813
22
mi
from 91732
Long Beach, CA
Click here to add this to my saved trials
Los Angeles, California 90095
25
mi
from 91732
Los Angeles, CA
Click here to add this to my saved trials
Louisville, Kentucky 40202
1812
mi
from 91732
Louisville, KY
Click here to add this to my saved trials
Lynchburg, Virginia 24501
2176
mi
from 91732
Lynchburg, VA
Click here to add this to my saved trials
Macon, Georgia 31201
1976
mi
from 91732
Macon, GA
Click here to add this to my saved trials
Madison, Wisconsin 53705
1653
mi
from 91732
Madison, WI
Click here to add this to my saved trials
Manhasset, New York 11030
2448
mi
from 91732
Manhasset, NY
Click here to add this to my saved trials
Maplewood, Minnesota 55109
1521
mi
from 91732
Maplewood, MN
Click here to add this to my saved trials
Marietta, Georgia 30060
1908
mi
from 91732
Marietta, GA
Click here to add this to my saved trials
Minneapolis, Minnesota 55402
1509
mi
from 91732
Minneapolis, MN
Click here to add this to my saved trials
Muncie, Indiana 47303
1835
mi
from 91732
Muncie, IN
Click here to add this to my saved trials
Nashville, Tennessee 37205
1758
mi
from 91732
Nashville, TN
Click here to add this to my saved trials
Natrona Heights, Pennsylvania 15065
2133
mi
from 91732
Natrona Heights, PA
Click here to add this to my saved trials
230 Park Avenue, 21st Floor
New York, New York 10169
1-888-669-6682)
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
2435
mi
from 91732
New York, NY
Click here to add this to my saved trials
Newark, Delaware 19713
2345
mi
from 91732
Newark, DE
Click here to add this to my saved trials
Newark, New Jersey 07103
2422
mi
from 91732
Newark, NJ
Click here to add this to my saved trials
Oakbrook Terrace, Illinois 60181
1712
mi
from 91732
Oakbrook Terrace, IL
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73104
1165
mi
from 91732
Oklahoma City, OK
Click here to add this to my saved trials
Omaha, Nebraska 68144
1291
mi
from 91732
Omaha, NE
Click here to add this to my saved trials
Orange, California 92868
21
mi
from 91732
Orange, CA
Click here to add this to my saved trials
Orange Park, Florida 32073
2130
mi
from 91732
Orange Park, FL
Click here to add this to my saved trials
Park Ridge, Illinois 60068
1720
mi
from 91732
Park Ridge, IL
Click here to add this to my saved trials
Pasadena, California 91105
9
mi
from 91732
Pasadena, CA
Click here to add this to my saved trials
Peoria, Illinois 61615
1616
mi
from 91732
Peoria, IL
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19102
2375
mi
from 91732
Philadelphia, PA
Click here to add this to my saved trials
Plano, Texas 75024
1220
mi
from 91732
Plano, TX
Click here to add this to my saved trials
Portland, Maine 04102
2612
mi
from 91732
Portland, ME
Click here to add this to my saved trials
Poughkeepsie, New York 12601
2433
mi
from 91732
Poughkeepsie, NY
Click here to add this to my saved trials
Providence, Rhode Island 02908
2562
mi
from 91732
Providence, RI
Click here to add this to my saved trials
Rapid City, South Dakota 57701
1049
mi
from 91732
Rapid City, SD
Click here to add this to my saved trials
Reno, Nevada 89502
385
mi
from 91732
Reno, NV
Click here to add this to my saved trials
Richmond, Indiana 47374
1860
mi
from 91732
Richmond, IN
Click here to add this to my saved trials
Richmond, Virginia 23249
2267
mi
from 91732
Richmond, VA
Click here to add this to my saved trials
Rochester, New York 14615
2244
mi
from 91732
Rochester, NY
Click here to add this to my saved trials
Sacramento, California 95825
364
mi
from 91732
Sacramento, CA
Click here to add this to my saved trials
Saint Paul, Minnesota 55102
1515
mi
from 91732
Saint Paul, MN
Click here to add this to my saved trials
San Antonio, Texas 78207
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
1187
mi
from 91732
San Antonio, TX
Click here to add this to my saved trials
San Diego, California 92123
100
mi
from 91732
San Diego, CA
Click here to add this to my saved trials
San Marino, California 91108
6
mi
from 91732
San Marino, CA
Click here to add this to my saved trials
San Pablo, California 94806
359
mi
from 91732
San Pablo, CA
Click here to add this to my saved trials
Sarasota, Florida 34239
2148
mi
from 91732
Sarasota, FL
Click here to add this to my saved trials
Slidell, Louisiana 70458
1666
mi
from 91732
Slidell, LA
Click here to add this to my saved trials
Stanford, California 94305
328
mi
from 91732
Stanford, CA
Click here to add this to my saved trials
Staten Island, New York 10312
2424
mi
from 91732
Staten Island, NY
Click here to add this to my saved trials
Tampa, Florida 33613
2133
mi
from 91732
Tampa, FL
Click here to add this to my saved trials