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Demonstration of Reverse Remodeling Effects of Entresto. Using Echocardiography Endocardial Surface Analysis | Clinical Trials | Clareo Health

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

Demonstration of Reverse Remodeling Effects of Entresto (Valsartan/Sacubitril) Using Echocardiography Endocardial Surface Analysis

NCT02754518•University of Chicago

View on ClinicalTrials.gov

Summary

Detailed 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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Males and females aged ≥18 years
•2. 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
•3. Stable and optimized on an angiotensin-converting-enzyme inhibitor (ACEI) equivalent to enalapril ≥ 10 twice a day (BID) for at least 4 weeks
•4. Stable and optimized on a beta-blocker for at least 4 weeks
•5. Optimized dosing of aldosterone antagonist at stable dose for at least 4 weeks

Exclusion Criteria

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

Locations (1)

University of Chicago Medical Center

Chicago, Illinois, United States

Key Dates

Start Date

April 1, 2016

Primary Completion Date

April 1, 2019

Completion Date

April 1, 2019

Last Updated

January 29, 2021

Enrollment

ACTUAL participants

Conditions

Heart Failure

Interventions

Entresto

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 29, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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