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

Completed · Phase 4 · Has a placebo group

Conditions studied: Heart Failure and Reduced Ejection Fraction

In brief

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.

Key facts

Study ID

NCT02874794

Run by

Novartis Pharmaceuticals

People needed

465

Starts

2016-08-17

Expected to finish

2019-01-26

Last updated by the study team

2021-01-05

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

Where it is running

• Novartis Investigative Site — Little Rock, Arkansas, United States
• Novartis Investigative Site — Beverly Hills, California, United States
• Novartis Investigative Site — Huntington Beach, California, United States
• Novartis Investigative Site — Newport Beach, California, United States
• Novartis Investigative Site — Northridge, California, United States
• Novartis Investigative Site — Santa Ana, California, United States
• Novartis Investigative Site — Van Nuys, California, United States
• Novartis Investigative Site — Greenwich, Connecticut, United States
• Novartis Investigative Site — Norwalk, Connecticut, United States
• Novartis Investigative Site — Stamford, Connecticut, United States
• Novartis Investigative Site — Trumbull, Connecticut, United States
• Novartis Investigative Site — Newark, Delaware, United States
• Novartis Investigative Site — Atlantis, Florida, United States
• Novartis Investigative Site — Aventura, Florida, United States
• Novartis Investigative Site — Bradenton, Florida, United States
• Novartis Investigative Site — Coral Gables, Florida, United States
• Novartis Investigative Site — Daytona Beach, Florida, United States
• Novartis Investigative Site — Doral, Florida, United States
• Novartis Investigative Site — Fort Lauderdale, Florida, United States
• Novartis Investigative Site — Hialeah, Florida, United States
• Novartis Investigative Site — Inverness, Florida, United States
• Novartis Investigative Site — Jacksonville, Florida, United States
• Novartis Investigative Site — Jupiter, Florida, United States
• Novartis Investigative Site — Miami, Florida, United States
• Novartis Investigative Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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