Heart Failure Clinical Trial

Study of Effects of Sacubitril/Valsartan vs. Enalapril on Aortic Stiffness in Patients With Mild to Moderate HF With Reduced Ejection Fraction

Summary

To determine whether treatment with sacubitril/valsartan provides a superior effect on aortic characteristic impedance compared to enalapril in patients with heart failure and reduced ejection fraction (left ventricular ejection fraction [LVEF] ≤ 40%) after 12 weeks of treatment. The primary endpoint is the change in aortic characteristic impedance (Zc = dP/dQ in early systole) between baseline and Week 12.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

History of HTN and one of the following at BOTH screening and pre-randomization:

SBP >105 mm Hg on antihypertensive medication.
SBP >/= 140 mm Hg and NOT on antihypertensive medication.
NYHA class I-III heart failure and with reduced ejection fraction
On stable doses of treatment with guideline-directed therapy, other than ACEis and ARBs prior to randomization.

If the patient is currently taking an ACEi, a 36-hour washout is required prior to randomization (Visit 2).
If the patient is currently taking an ARB, they must discontinue the ARB before initiation of study treatment however washout is not required.
On an optimal medical regiment of diuretics and background medications to effectively treat co-morbidities such as HTN, DM, and coronary artery disease.

Key Exclusion Criteria:

History of hypersensitivity to any of the study drigs, including history of hypersensitivity to drugs of similar chemical classes, or allergy to ACEis, ARBs, or NEP inhibitors as well as known or suspected contraindications to the study drugs.
Previous history of intolerance to sacubitril and valsartan, ACEi or ARB standard of care doses despite appropriate and gradual up-titration.
History of angioedema, drug-related or otherwise.
Requirement of treatment with both ACE inhibitor and ARB.
Current or prior treatment with sacubitril and valsartan.

Study is for people with:

Heart Failure

Phase:

Phase 4

Estimated Enrollment:

465

Study ID:

NCT02874794

Recruitment Status:

Completed

Sponsor:

Novartis Pharmaceuticals

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There are 80 Locations for this study

See Locations Near You

Novartis Investigative Site
Birmingham Alabama, 35294, United States
Novartis Investigative Site
Little Rock Arkansas, 72202, United States
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Beverly Hills California, 90211, United States
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Huntington Beach California, 92648, United States
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Newport Beach California, 92663, United States
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Northridge California, 91325, United States
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Santa Ana California, 92704, United States
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Van Nuys California, 91405, United States
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Greenwich Connecticut, 06830, United States
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Norwalk Connecticut, 06851, United States
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Stamford Connecticut, 06905, United States
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Trumbull Connecticut, 06611, United States
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Newark Delaware, 19713, United States
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Atlantis Florida, 33462, United States
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Aventura Florida, 33180, United States
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Bradenton Florida, 34209, United States
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Coral Gables Florida, 33134, United States
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Daytona Beach Florida, 32117, United States
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Doral Florida, 33166, United States
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Fort Lauderdale Florida, 33312, United States
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Hialeah Florida, 33012, United States
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Inverness Florida, 34452, United States
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Jacksonville Florida, 32223, United States
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Jupiter Florida, 33458, United States
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Miami Florida, 33125, United States
Novartis Investigative Site
Miami Florida, 33126, United States
Novartis Investigative Site
Miami Florida, 33133, United States
Novartis Investigative Site
Miami Florida, 33135, United States
Novartis Investigative Site
Miami Florida, 33144, United States
Novartis Investigative Site
Miami Florida, 33155, United States
Novartis Investigative Site
Miami Florida, 33165, United States
Novartis Investigative Site
Miami Florida, 33166, United States
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Miami Florida, 33176, United States
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Naples Florida, 34102, United States
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Saint Augustine Florida, 32086, United States
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Athens Georgia, 30606, United States
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Augusta Georgia, 30912, United States
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Blue Ridge Georgia, 30513, United States
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Eatonton Georgia, 31024, United States
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Macon Georgia, 31201, United States
Novartis Investigative Site
Coeur d'Alene Idaho, 83814, United States
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Fairview Heights Illinois, 62208, United States
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Gurnee Illinois, 60031, United States
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Overland Park Kansas, 66209, United States
Novartis Investigative Site
Owensboro Kentucky, 42303, United States
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Baton Rouge Louisiana, 70808, United States
Novartis Investigative Site
Eunice Louisiana, 70535, United States
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Minden Louisiana, 71055, United States
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Monroe Louisiana, 71201, United States
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Slidell Louisiana, 70458, United States
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Baltimore Maryland, 21237, United States
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Alpena Michigan, 49707, United States
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Owosso Michigan, 48867, United States
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Saginaw Michigan, 48604, United States
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Lincoln Nebraska, 68506, United States
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Omaha Nebraska, 68131, United States
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Las Vegas Nevada, 89128, United States
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Hillsborough New Jersey, 08844, United States
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Linden New Jersey, 07036, United States
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Manalapan New Jersey, 07726, United States
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Mountain Lakes New Jersey, 07046, United States
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Bronx New York, 10469, United States
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Buffalo New York, 14215, United States
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Lake Success New York, 11042, United States
Novartis Investigative Site
Rosedale New York, 11422, United States
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Charlotte North Carolina, 28227, United States
Novartis Investigative Site
Greenville North Carolina, 27834, United States
Novartis Investigative Site
Lenoir North Carolina, 28645, United States
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Yardley Pennsylvania, 19067, United States
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Jackson Tennessee, 38301, United States
Novartis Investigative Site
Amarillo Texas, 79106, United States
Novartis Investigative Site
Houston Texas, 77094, United States
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McKinney Texas, 75069, United States
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McKinney Texas, 75071, United States
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Sherman Texas, 75092, United States
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Tomball Texas, 77375, United States
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Webster Texas, 77598, United States
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Richmond Virginia, 23219, United States
Novartis Investigative Site
Richland Washington, 99352, United States
Novartis Investigative Site
Spokane Washington, 99204, United States
Novartis Investigative Site
Manitowoc Wisconsin, 54220, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 4

Estimated Enrollment:

465

Study ID:

NCT02874794

Recruitment Status:

Completed

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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