Heart Failure Clinical Trial
Comparison of Sacubitril/Valsartan Versus Enalapril on Effect on NT-proBNP in Patients Stabilized From an Acute Heart Failure Episode.
Summary
The purpose of this study was 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%).
Eligibility Criteria
Key Inclusion Criteria:
Possess the capacity to provide written informed consent which must be obtained before any assessment is performed.
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.
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
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%.
Elevated NT-proBNP ≥ 1600pg/mL OR BNP ≥400 pg/mL during current hospitalization.
Key Exclusion Criteria:
Currently taking sacubitril/valsartan tablets or any use within the past 30 days.
Enrollment in any other clinical trial involving an investigational agent or investigational device.
History of hypersensitivity, known or suspected contraindications, or intolerance to any of the study drugs, including ACEIs, ARBs, or Sacubitril (NEP inhibitor).
Patients with a known history of angioedema related to previous ACE inhibitor or ARB therapy.
Requirement of treatment with both ACE inhibitor and ARB.
eGFR < 30 ml/min/1.73 m2 as measured by the simplified Modification of Diet in Renal Disease (MDRD) formula at screening.
Serum potassium > 5.2 mEq/L at screening.
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
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.
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.
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.
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There are 121 Locations for this study
Birmingham Alabama, 35294, United States
Fort Smith Arkansas, 72901, United States
Little Rock Arkansas, 72205, United States
Bakersfield California, 93301, United States
Fresno California, 93701, United States
Long Beach California, 90806, United States
Los Angeles California, 90033, United States
Los Angeles California, 90073, United States
Orange California, 92868, United States
Pasadena California, 91105, United States
Sacramento California, 95817, United States
San Diego California, 92123, United States
San Marino California, 91108, United States
San Pablo California, 94806, United States
Stanford California, 94305, United States
Denver Colorado, , United States
Littleton Colorado, 80120, United States
Bridgeport Connecticut, 06610, United States
Hartford Connecticut, 06102, United States
Hartford Connecticut, 06105, United States
West Haven Connecticut, 06516, United States
Washington District of Columbia, 20422, United States
Atlantis Florida, 33462, United States
Daytona Beach Florida, 32117, United States
Fort Lauderdale Florida, 33308, United States
Gainesville Florida, 32608, United States
Gainesville Florida, 32610, United States
Hollywood Florida, 33021, United States
Jacksonville Florida, 32209, United States
Jacksonville Florida, 32216, United States
Lakeland Florida, 33805, United States
Sarasota Florida, 34239, United States
Tampa Florida, 33612, United States
Tampa Florida, 34667, United States
Vero Beach Florida, 32960, United States
Winter Haven Florida, 33881, United States
Augusta Georgia, 30901, United States
Macon Georgia, 31201, United States
Marietta Georgia, 30060, United States
Boise Idaho, 83702, United States
Aurora Illinois, 60504, United States
Elk Grove Village Illinois, 60007, United States
Oakbrook Terrace Illinois, 60181, United States
Park Ridge Illinois, 60068, United States
Peoria Illinois, 61606, United States
Peoria Illinois, 61614, United States
Winfield Illinois, 60190, United States
Elkhart Indiana, 46514, United States
Indianapolis Indiana, 46202, United States
Indianapolis Indiana, 46237, United States
Muncie Indiana, 47303, United States
Richmond Indiana, 47374, United States
Des Moines Iowa, 50314, United States
Kansas City Kansas, 66103, United States
Louisville Kentucky, 40205, United States
Louisville Kentucky, 40245, United States
Alexandria Louisiana, 71301, United States
Baton Rouge Louisiana, 70808, United States
Slidell Louisiana, 70458, United States
Bangor Maine, 04401, United States
Annapolis Maryland, 21401, United States
Baltimore Maryland, 21215, United States
Boston Massachusetts, 02215, United States
Boston Massachusetts, , United States
Ann Arbor Michigan, 48106, United States
Bay City Michigan, 48708, United States
Detroit Michigan, 48201, United States
Maplewood Minnesota, 55109, United States
Minneapolis Minnesota, 55417, United States
Saint Paul Minnesota, 55101, United States
Saint Paul Minnesota, 55102, United States
Hattiesburg Mississippi, 39401, United States
Jackson Mississippi, 39216, United States
Kansas City Missouri, 64108, United States
Omaha Nebraska, 68198, United States
Reno Nevada, 89502, United States
Camden New Jersey, 08103, United States
Elmer New Jersey, 08318, United States
Haddon Heights New Jersey, 08035, United States
Newark New Jersey, 07102, United States
Bronx New York, 10461, United States
Bronx New York, 10467, United States
Brooklyn New York, 11215, United States
Buffalo New York, 14215, United States
Johnson City New York, 13790, United States
Manhasset New York, 11030, United States
New York New York, 10016, United States
New York New York, 10029, United States
New York New York, 10032, United States
Poughkeepsie New York, 12601, United States
Rochester New York, 14621, United States
Staten Island New York, 10310, United States
Chapel Hill North Carolina, 27599, United States
Greenville North Carolina, 27834, United States
Winston-Salem North Carolina, 27157, United States
Grand Forks North Dakota, 58201, United States
Cincinnati Ohio, 45220, United States
Toledo Ohio, 43608, United States
Oklahoma City Oklahoma, 73122, United States
Tulsa Oklahoma, 74104, United States
Abington Pennsylvania, 19001, United States
Camp Hill Pennsylvania, 17011, United States
Natrona Heights Pennsylvania, 15065, United States
Philadelphia Pennsylvania, 19102, United States
Providence Rhode Island, 02903, United States
Charleston South Carolina, 29403, United States
Greenville South Carolina, 29615, United States
Rapid City South Dakota, 57701, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37212, United States
Dallas Texas, 75204, United States
Dallas Texas, 75390, United States
Houston Texas, 77030, United States
Plano Texas, 75093, United States
San Antonio Texas, 78229, United States
White River Junction Vermont, 05009, United States
Charlottesville Virginia, 22908, United States
Lynchburg Virginia, 24501, United States
Richmond Virginia, 23298, United States
Virginia Beach Virginia, 23454, United States
Clarksburg West Virginia, 26301, United States
Madison Wisconsin, 53792, United States
Wausau Wisconsin, 54401, United States
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