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.
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 = 40%, as determined by any local measurement made within the past 12 months using echocardiography, MUGA, CT scanning, MRI, ventricular angiography or single-photon emission computed tomography (SPECT), provided no subsequent measurement above 40%. Patients who have had an intervening medical event (e.g. myocardial infarction) or procedure (e.g. revascularization, cardiac resynchronization), must have a reassessment of EF ≥ 3 months following the event to ensure that eligibility criteria are still met.
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.
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There are 80 Locations for this study
Birmingham Alabama, 35294, United States
Little Rock Arkansas, 72202, United States
Beverly Hills California, 90211, United States
Huntington Beach California, 92648, United States
Newport Beach California, 92663, United States
Northridge California, 91325, United States
Santa Ana California, 92704, United States
Van Nuys California, 91405, United States
Greenwich Connecticut, 06830, United States
Norwalk Connecticut, 06851, United States
Stamford Connecticut, 06905, United States
Trumbull Connecticut, 06611, United States
Newark Delaware, 19713, United States
Atlantis Florida, 33462, United States
Aventura Florida, 33180, United States
Bradenton Florida, 34209, United States
Coral Gables Florida, 33134, United States
Daytona Beach Florida, 32117, United States
Doral Florida, 33166, United States
Fort Lauderdale Florida, 33312, United States
Hialeah Florida, 33012, United States
Inverness Florida, 34452, United States
Jacksonville Florida, 32223, United States
Jupiter Florida, 33458, United States
Miami Florida, 33125, United States
Miami Florida, 33126, United States
Miami Florida, 33133, United States
Miami Florida, 33135, United States
Miami Florida, 33144, United States
Miami Florida, 33155, United States
Miami Florida, 33165, United States
Miami Florida, 33166, United States
Miami Florida, 33176, United States
Naples Florida, 34102, United States
Saint Augustine Florida, 32086, United States
Athens Georgia, 30606, United States
Augusta Georgia, 30912, United States
Blue Ridge Georgia, 30513, United States
Eatonton Georgia, 31024, United States
Macon Georgia, 31201, United States
Coeur d'Alene Idaho, 83814, United States
Fairview Heights Illinois, 62208, United States
Gurnee Illinois, 60031, United States
Overland Park Kansas, 66209, United States
Owensboro Kentucky, 42303, United States
Baton Rouge Louisiana, 70808, United States
Eunice Louisiana, 70535, United States
Minden Louisiana, 71055, United States
Monroe Louisiana, 71201, United States
Slidell Louisiana, 70458, United States
Baltimore Maryland, 21237, United States
Alpena Michigan, 49707, United States
Owosso Michigan, 48867, United States
Saginaw Michigan, 48604, United States
Lincoln Nebraska, 68506, United States
Omaha Nebraska, 68131, United States
Las Vegas Nevada, 89128, United States
Hillsborough New Jersey, 08844, United States
Linden New Jersey, 07036, United States
Manalapan New Jersey, 07726, United States
Mountain Lakes New Jersey, 07046, United States
Bronx New York, 10469, United States
Buffalo New York, 14215, United States
Lake Success New York, 11042, United States
Rosedale New York, 11422, United States
Charlotte North Carolina, 28227, United States
Greenville North Carolina, 27834, United States
Lenoir North Carolina, 28645, United States
Yardley Pennsylvania, 19067, United States
Jackson Tennessee, 38301, United States
Amarillo Texas, 79106, United States
Houston Texas, 77094, United States
McKinney Texas, 75069, United States
McKinney Texas, 75071, United States
Sherman Texas, 75092, United States
Tomball Texas, 77375, United States
Webster Texas, 77598, United States
Richmond Virginia, 23219, United States
Richland Washington, 99352, United States
Spokane Washington, 99204, United States
Manitowoc Wisconsin, 54220, United States
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