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
Fort Lauderdale, Florida 33313
?
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
Abington, Pennsylvania 19001
?
mi
from
Abington, PA
Click here to add this to my saved trials
Alexandria, Louisiana 71301
?
mi
from
Alexandria, LA
Click here to add this to my saved trials
Ann Arbor, Michigan 48109
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Annapolis, Maryland 21401
?
mi
from
Annapolis, MD
Click here to add this to my saved trials
Atlantis, Florida 33462
?
mi
from
Atlantis, FL
Click here to add this to my saved trials
Augusta, Georgia 30904
?
mi
from
Augusta, GA
Click here to add this to my saved trials
Aurora, Illinois 60504
?
mi
from
Aurora, IL
Click here to add this to my saved trials
Bakersfield, California 93301
?
mi
from
Bakersfield, CA
Click here to add this to my saved trials
Baltimore, Maryland 21287
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Bangor, Maine 04401
?
mi
from
Bangor, ME
Click here to add this to my saved trials
Baton Rouge, Louisiana 70808
?
mi
from
Baton Rouge, LA
Click here to add this to my saved trials
Bay City, Michigan 48708
?
mi
from
Bay City, MI
Click here to add this to my saved trials
Birmingham, Alabama 35209
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Boise, Idaho 83712
?
mi
from
Boise, ID
Click here to add this to my saved trials
Boston, Massachusetts 02118
?
mi
from
Boston, MA
Click here to add this to my saved trials
Bridgeport, Connecticut 06606
?
mi
from
Bridgeport, CT
Click here to add this to my saved trials
Bronx, New York 10461
?
mi
from
Bronx, NY
Click here to add this to my saved trials
Brooklyn, New York 11218
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
Buffalo, New York 14215
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
Camden, New Jersey 08103
?
mi
from
Camden, NJ
Click here to add this to my saved trials
Camp Hill, Pennsylvania 17011
?
mi
from
Camp Hill, PA
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
Charleston, South Carolina 29407
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charleston, West Virginia 25304
?
mi
from
Charleston, WV
Click here to add this to my saved trials
Charlottesville, Virginia 22904
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
Cincinnati, Ohio 45229
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Clarksburg, West Virginia 26301
?
mi
from
Clarksburg, WV
Click here to add this to my saved trials
Dallas, Texas 75216
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Daytona Beach, Florida 32117
?
mi
from
Daytona Beach, FL
Click here to add this to my saved trials
Denver, Colorado 80262
?
mi
from
Denver, CO
Click here to add this to my saved trials
Des Moines, Iowa 50314
?
mi
from
Des Moines, IA
Click here to add this to my saved trials
Detroit, Michigan 48202
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Elk Grove Village, Illinois 60007
?
mi
from
Elk Grove Village, IL
Click here to add this to my saved trials
Elkhart, Indiana 46514
?
mi
from
Elkhart, IN
Click here to add this to my saved trials
Elmer, New Jersey 08318
?
mi
from
Elmer, NJ
Click here to add this to my saved trials
Fort Smith, Arkansas 72901
?
mi
from
Fort Smith, AR
Click here to add this to my saved trials
Fresno, California 93710
?
mi
from
Fresno, CA
Click here to add this to my saved trials
Gainesville, Florida 32608
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
Grand Forks, North Dakota 58201
?
mi
from
Grand Forks, ND
Click here to add this to my saved trials
Greenville, North Carolina 27834
?
mi
from
Greenville, NC
Click here to add this to my saved trials
Greenville, South Carolina 29605
?
mi
from
Greenville, SC
Click here to add this to my saved trials
Haddon Heights, New Jersey 08035
?
mi
from
Haddon Heights, NJ
Click here to add this to my saved trials
Hartford, Connecticut 06106
?
mi
from
Hartford, CT
Click here to add this to my saved trials
Hattiesburg, Mississippi 39401
?
mi
from
Hattiesburg, MS
Click here to add this to my saved trials
Hollywood, Florida 33021
?
mi
from
Hollywood, FL
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Indianapolis, Indiana 46202
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Jackson, Mississippi 39209
?
mi
from
Jackson, MS
Click here to add this to my saved trials
Jacksonville, Florida 32216
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Johnson City, New York 13790
?
mi
from
Johnson City, NY
Click here to add this to my saved trials
Kansas City, Kansas 66160
?
mi
from
Kansas City, KS
Click here to add this to my saved trials
Kansas City, Missouri 64111
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
Lakeland, Florida 33805
?
mi
from
Lakeland, FL
Click here to add this to my saved trials
Little Rock, Arkansas 72204
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Littleton, Colorado 80120
?
mi
from
Littleton, CO
Click here to add this to my saved trials
Long Beach, California 90813
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
Los Angeles, California 90095
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Louisville, Kentucky 40202
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Lynchburg, Virginia 24501
?
mi
from
Lynchburg, VA
Click here to add this to my saved trials
Macon, Georgia 31201
?
mi
from
Macon, GA
Click here to add this to my saved trials
Madison, Wisconsin 53705
?
mi
from
Madison, WI
Click here to add this to my saved trials
Manhasset, New York 11030
?
mi
from
Manhasset, NY
Click here to add this to my saved trials
Maplewood, Minnesota 55109
?
mi
from
Maplewood, MN
Click here to add this to my saved trials
Marietta, Georgia 30060
?
mi
from
Marietta, GA
Click here to add this to my saved trials
Minneapolis, Minnesota 55402
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
Muncie, Indiana 47303
?
mi
from
Muncie, IN
Click here to add this to my saved trials
Nashville, Tennessee 37205
?
mi
from
Nashville, TN
Click here to add this to my saved trials
Natrona Heights, Pennsylvania 15065
?
mi
from
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...
?
mi
from
New York, NY
Click here to add this to my saved trials
Newark, Delaware 19713
?
mi
from
Newark, DE
Click here to add this to my saved trials
Newark, New Jersey 07103
?
mi
from
Newark, NJ
Click here to add this to my saved trials
Oakbrook Terrace, Illinois 60181
?
mi
from
Oakbrook Terrace, IL
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73104
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Omaha, Nebraska 68144
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Orange, California 92868
?
mi
from
Orange, CA
Click here to add this to my saved trials
Orange Park, Florida 32073
?
mi
from
Orange Park, FL
Click here to add this to my saved trials
Park Ridge, Illinois 60068
?
mi
from
Park Ridge, IL
Click here to add this to my saved trials
Pasadena, California 91105
?
mi
from
Pasadena, CA
Click here to add this to my saved trials
Peoria, Illinois 61615
?
mi
from
Peoria, IL
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19102
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Plano, Texas 75024
?
mi
from
Plano, TX
Click here to add this to my saved trials
Portland, Maine 04102
?
mi
from
Portland, ME
Click here to add this to my saved trials
Poughkeepsie, New York 12601
?
mi
from
Poughkeepsie, NY
Click here to add this to my saved trials
Providence, Rhode Island 02908
?
mi
from
Providence, RI
Click here to add this to my saved trials
Rapid City, South Dakota 57701
?
mi
from
Rapid City, SD
Click here to add this to my saved trials
Reno, Nevada 89502
?
mi
from
Reno, NV
Click here to add this to my saved trials
Richmond, Indiana 47374
?
mi
from
Richmond, IN
Click here to add this to my saved trials
Richmond, Virginia 23249
?
mi
from
Richmond, VA
Click here to add this to my saved trials
Rochester, New York 14615
?
mi
from
Rochester, NY
Click here to add this to my saved trials
Sacramento, California 95825
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
Saint Paul, Minnesota 55102
?
mi
from
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...
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Diego, California 92123
?
mi
from
San Diego, CA
Click here to add this to my saved trials
San Marino, California 91108
?
mi
from
San Marino, CA
Click here to add this to my saved trials
San Pablo, California 94806
?
mi
from
San Pablo, CA
Click here to add this to my saved trials
Sarasota, Florida 34239
?
mi
from
Sarasota, FL
Click here to add this to my saved trials
Slidell, Louisiana 70458
?
mi
from
Slidell, LA
Click here to add this to my saved trials
Stanford, California 94305
?
mi
from
Stanford, CA
Click here to add this to my saved trials
Staten Island, New York 10312
?
mi
from
Staten Island, NY
Click here to add this to my saved trials
Tampa, Florida 33613
?
mi
from
Tampa, FL
Click here to add this to my saved trials