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



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:50 - Any
Updated:3/2/2019
Start Date:August 17, 2016
End Date:March 7, 2019
Contact:Novartis Pharmaceuticals
Phone:1-888-669-6682

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A Multicenter, Randomized, Double-blind, Double-dummy, Parallel Group, Active-controlled, Forced-titration, 12-week Comparison of Combined Angiotensin-neprilysin Inhibition With Sacubitril and Valsartan Versus Enalapril on Changes in Central Aortic Stiffness in Patients With Heart Failure and Reduced Ejection Fraction (HFrEF)

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.


Inclusion Criteria:

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

1. SBP >105 mm Hg on antihypertensive medication.

2. 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.

1. If the patient is currently taking an ACEi, a 36-hour washout is required prior
to randomization (Visit 2).

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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