Heart Failure Clinical Trial
Demonstration of Reverse Remodeling Effects of Entresto. Using Echocardiography Endocardial Surface Analysis
Summary
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.
Full Description
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. Furthermore, Metaiodobenzylguanidine (MIBG) scintigraphy and the heart to mediastinum ratio will be used to assess Left Ventricle (LV) volume regression and risk reduction. The investigators also intend to measure the effects of valsartan/sacubitril on exercise capacity as assessed by the 6 minute walk test and peak Volume of Oxygen (V02) on cardiopulmonary exercise testing. Additionally, the investigators will examine the impact of valsartan/sacubitril on functional status and quality of life using the Kansas City Cardiomyopathy Questionnaire (KCCQ) and Qualia Health (a novel iPhone application that incorporates Fitbit technology to provide a "real time" daily 6 minute step count and assesses quality of life using a series of short targeted questions. The investigators will also measure Brain Natriuretic Peptide (BNP), N-terminal of the Prohormone Brain Natriuretic Peptide (NT-proBNP), and Rho-kinase (a biomarker associated with heart failure) levels at multiple time-points throughout the study period.
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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)
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There is 1 Location for this study
Chicago Illinois, 60637, United States
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