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%).

View Eligibility Criteria

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.

Study is for people with:

Heart Failure

Phase:

Phase 4

Estimated Enrollment:

887

Study ID:

NCT02554890

Recruitment Status:

Completed

Sponsor:

Novartis Pharmaceuticals

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There are 121 Locations for this study

See Locations Near You

Novartis Investigative Site
Birmingham Alabama, 35294, United States
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Fort Smith Arkansas, 72901, United States
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Little Rock Arkansas, 72205, United States
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Bakersfield California, 93301, United States
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Fresno California, 93701, United States
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Long Beach California, 90806, United States
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Los Angeles California, 90033, United States
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Los Angeles California, 90073, United States
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Orange California, 92868, United States
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Pasadena California, 91105, United States
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Sacramento California, 95817, United States
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San Diego California, 92123, United States
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San Marino California, 91108, United States
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San Pablo California, 94806, United States
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Stanford California, 94305, United States
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Denver Colorado, , United States
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Littleton Colorado, 80120, United States
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Bridgeport Connecticut, 06610, United States
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Hartford Connecticut, 06102, United States
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Hartford Connecticut, 06105, United States
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West Haven Connecticut, 06516, United States
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Washington District of Columbia, 20422, United States
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Atlantis Florida, 33462, United States
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Daytona Beach Florida, 32117, United States
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Fort Lauderdale Florida, 33308, United States
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Gainesville Florida, 32608, United States
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Gainesville Florida, 32610, United States
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Hollywood Florida, 33021, United States
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Jacksonville Florida, 32209, United States
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Jacksonville Florida, 32216, United States
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Lakeland Florida, 33805, United States
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Sarasota Florida, 34239, United States
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Tampa Florida, 33612, United States
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Tampa Florida, 34667, United States
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Vero Beach Florida, 32960, United States
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Winter Haven Florida, 33881, United States
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Augusta Georgia, 30901, United States
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Macon Georgia, 31201, United States
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Marietta Georgia, 30060, United States
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Boise Idaho, 83702, United States
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Aurora Illinois, 60504, United States
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Elk Grove Village Illinois, 60007, United States
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Oakbrook Terrace Illinois, 60181, United States
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Park Ridge Illinois, 60068, United States
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Peoria Illinois, 61606, United States
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Peoria Illinois, 61614, United States
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Winfield Illinois, 60190, United States
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Elkhart Indiana, 46514, United States
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Indianapolis Indiana, 46202, United States
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Indianapolis Indiana, 46237, United States
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Muncie Indiana, 47303, United States
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Richmond Indiana, 47374, United States
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Des Moines Iowa, 50314, United States
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Kansas City Kansas, 66103, United States
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Louisville Kentucky, 40205, United States
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Louisville Kentucky, 40245, United States
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Alexandria Louisiana, 71301, United States
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Baton Rouge Louisiana, 70808, United States
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Slidell Louisiana, 70458, United States
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Bangor Maine, 04401, United States
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Annapolis Maryland, 21401, United States
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Baltimore Maryland, 21215, United States
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Boston Massachusetts, 02215, United States
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Boston Massachusetts, , United States
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Ann Arbor Michigan, 48106, United States
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Bay City Michigan, 48708, United States
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Detroit Michigan, 48201, United States
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Maplewood Minnesota, 55109, United States
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Minneapolis Minnesota, 55417, United States
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Saint Paul Minnesota, 55101, United States
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Saint Paul Minnesota, 55102, United States
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Hattiesburg Mississippi, 39401, United States
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Jackson Mississippi, 39216, United States
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Kansas City Missouri, 64108, United States
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Omaha Nebraska, 68198, United States
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Reno Nevada, 89502, United States
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Camden New Jersey, 08103, United States
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Elmer New Jersey, 08318, United States
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Haddon Heights New Jersey, 08035, United States
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Newark New Jersey, 07102, United States
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Bronx New York, 10461, United States
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Bronx New York, 10467, United States
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Brooklyn New York, 11215, United States
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Buffalo New York, 14215, United States
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Johnson City New York, 13790, United States
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Manhasset New York, 11030, United States
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New York New York, 10016, United States
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New York New York, 10029, United States
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New York New York, 10032, United States
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Poughkeepsie New York, 12601, United States
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Rochester New York, 14621, United States
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Staten Island New York, 10310, United States
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Chapel Hill North Carolina, 27599, United States
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Greenville North Carolina, 27834, United States
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Winston-Salem North Carolina, 27157, United States
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Grand Forks North Dakota, 58201, United States
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Cincinnati Ohio, 45220, United States
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Toledo Ohio, 43608, United States
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Oklahoma City Oklahoma, 73122, United States
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Tulsa Oklahoma, 74104, United States
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Abington Pennsylvania, 19001, United States
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Camp Hill Pennsylvania, 17011, United States
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Natrona Heights Pennsylvania, 15065, United States
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Philadelphia Pennsylvania, 19102, United States
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Providence Rhode Island, 02903, United States
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Charleston South Carolina, 29403, United States
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Greenville South Carolina, 29615, United States
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Rapid City South Dakota, 57701, United States
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Nashville Tennessee, 37203, United States
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Nashville Tennessee, 37212, United States
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Dallas Texas, 75204, United States
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Dallas Texas, 75390, United States
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Houston Texas, 77030, United States
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Plano Texas, 75093, United States
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San Antonio Texas, 78229, United States
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White River Junction Vermont, 05009, United States
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Charlottesville Virginia, 22908, United States
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Lynchburg Virginia, 24501, United States
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Richmond Virginia, 23298, United States
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Virginia Beach Virginia, 23454, United States
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Clarksburg West Virginia, 26301, United States
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Madison Wisconsin, 53792, United States
Novartis Investigative Site
Wausau Wisconsin, 54401, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 4

Estimated Enrollment:

887

Study ID:

NCT02554890

Recruitment Status:

Completed

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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