Demonstration of Reverse Remodeling Effects of Entresto. Using Echocardiography Endocardial Surface Analysis

Completed · Phase 4

Conditions studied: Heart Failure

In brief

This study intends to measure the effects of valsartan/sacubitril compared to baseline standard medical heart failure therapy on reverse remodeling using echocardiographic endocardial surface analysis techniques to assess changes in ventricular volume, function, and shape.

Key facts

Study ID

NCT02754518

Run by

University of Chicago

People needed

40

Starts

2016-04-01

Expected to finish

2019-04-01

Last updated by the study team

2021-01-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females aged ≥18 years
• Congestive Heart Failure (CHF) New York Heart Association (NYHA) class II-IV with 25%≤ Left Ventricular Ejection Fraction (LVEF) ≤40% (ECHO within last 6 months)
• NT-proBNP ≥ 600 pg/mL OR
• NT-proBNP ≥ 400 pg/mL and a hospitalization for heart failure within the last 12 months
• Stable and optimized on an angiotensin-converting-enzyme inhibitor (ACEI) equivalent to enalapril ≥ 10 twice a day (BID) for at least 4 weeks
• Stable and optimized on a beta-blocker for at least 4 weeks
• Optimized dosing of aldosterone antagonist at stable dose for at least 4 weeks

You may not qualify if…

• History of angioedema
• estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73 m2 at screening
• Serum potassium > 5.2 mmol/L at screening
• Symptomatic hypotension as defined by Investigator, systolic blood pressure (SBP) < 100 mmHg at screening
• Current acute decompensated heart failure
• History of severe pulmonary disease
• Active malignancy
• Requirement for treatment with both angiotensin-converting-enzyme inhibitor (ACEI) and angiotensin receptor blockers (ARB)

Where it is running

• University of Chicago Medical Center — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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