Demonstration of Reverse Remodeling Effects of Entresto. Using Echocardiography Endocardial Surface Analysis
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ClinicalTrials.gov Identifier: NCT02754518 |
Recruitment Status :
Completed
First Posted : April 28, 2016
Results First Posted : January 29, 2021
Last Update Posted : January 29, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Heart Failure | Drug: Entresto | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Demonstration of Reverse Remodeling Effects of Entresto (Valsartan/Sacubitril) Using Echocardiography Endocardial Surface Analysis |
Actual Study Start Date : | April 2016 |
Actual Primary Completion Date : | April 2019 |
Actual Study Completion Date : | April 2019 |

Arm | Intervention/treatment |
---|---|
Open label Entresto
All subjects will take Entresto, a drug recently approved by the US Food and Drug Administration (FDA) for heart failure. In this study subjects will take this drug as they normally would for their standard of care.
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Drug: Entresto
Other Name: valsartan/sacubitril |
- Change From Baseline in LV Remodeling 2D End-Diastolic Diameter (cm) [ Time Frame: Baseline,1 year ]LV Remodeling 2D End-Diastolic Diameter (cm)
- Change From Baseline in LV Remodeling 2D End-Systolic Diameter (cm) [ Time Frame: Baseline,1 year ]LV Remodeling 2D End-Systolic Diameter (cm)
- Change From Baseline in LV Remodeling Global Longitudinal Strain (%) [ Time Frame: Baseline,1 year ]LV Remodeling Global Longitudinal Strain (%)
- Change From Baseline in LV Remodeling Left Atrial Volume (mL) [ Time Frame: Baseline,1 year ]LV Remodeling Left Atrial Volume (mL)
- Change From Baseline in LV Remodeling 3D End-Diastolic Volume (mL) [ Time Frame: Baseline,1 year ]LV Remodeling 3D End-Diastolic Volume (mL)
- Change From Baseline in LV Remodeling 3D End-Systolic Volume (mL) [ Time Frame: Baseline,1 year ]LV Remodeling 3D End-Systolic Volume (mL)
- Change From Baseline in LV Remodeling LV Ejection Fraction (%) [ Time Frame: Baseline,1 year ]LV Remodeling LV Ejection Fraction (%)
- Change From Baseline in LV Remodeling Conicity (%) [ Time Frame: Baseline,1 year ]LV Remodeling Conicity (%)
- Change From Baseline in LV Remodeling Sphericity (%) [ Time Frame: Baseline,1 year ]LV Remodeling Sphericity (%)
- Change From Baseline in RV Remodeling End-Diastolic Volume (mL) [ Time Frame: Baseline,1 year ]RV Remodeling End-Diastolic Volume (mL)
- Change From Baseline in RV Remodeling End Systolic Volume (mL) [ Time Frame: Baseline,1 year ]RV Remodeling End Systolic Volume (mL)
- Change From Baseline in RV Remodeling Ejection Fraction (%) [ Time Frame: Baseline,1 year ]RV Remodeling Ejection Fraction (%)
- Change From Baseline in RV Remodeling Septal Curvature (%) [ Time Frame: Baseline,1 year ]RV Remodeling Septal Curvature (%)
- Change From Baseline in RV Remodeling Free-Wall Curvature (%) [ Time Frame: Baseline,1 year ]RV Remodeling Free-Wall Curvature (%)
- Change From Baseline in RV Remodeling Tricuspid Regurgitation [ Time Frame: Baseline,1 year ]RV Remodeling Tricuspid Regurgitation
- Change From Baseline in Rho-associated Protein Kinase (ROCK) [ Time Frame: Baseline,1 year ]Rho-associated protein kinase (ROCK)
- Change From Baseline in (MIBG) Early hm Ratio [ Time Frame: Baseline,1 year ]Cardiac 123Iodine-metaiodobenzylguanidine (MIBG) Early heart/mediastinum ratio (hm) ratio
- Change From Baseline in (MIBG) Late hm Ratio [ Time Frame: Baseline,1 year ]Cardiac 123Iodine-metaiodobenzylguanidine (MIBG) Late heart/mediastinum ratio (hm) ratio
- Change From Baseline in NT-proBNP Levels [ Time Frame: Baseline,1 year ]NT-proBNP levels (pg/ml)
- Change From Baseline in Exercise Performance - 6 Minute Walk [ Time Frame: Baseline,1 year ]Exercise Performance - 6 Minute Walk
- Change From Baseline in Exercise Performance - CPX - Peak VO2 (mL/kg/Min) [ Time Frame: Baseline,1 year ]Exercise Performance - CPX - Peak VO2 (mL/kg/min)
- Change From Baseline in Exercise Performance - CPX - Peak RER [ Time Frame: Baseline,1 year ]Exercise Performance - CPX - Peak RER (Respiratory Exchange Ratio)
- Change From Baseline in Exercise Performance - CPX - VE/VC02 [ Time Frame: Baseline,1 year ]Exercise Performance - CPX - VE/VC02
- Change From Baseline in Blood Pressure - Systolic (mmHg) [ Time Frame: Baseline,1 year ]Blood Pressure - Systolic (mmHg)
- Change From Baseline in Blood Pressure - Diastolic (mmHg) [ Time Frame: Baseline,1 year ]Blood Pressure - Diastolic (mmHg)
- Change From Baseline in KCCQ - Physical Limitation [ Time Frame: Baseline,1 year ]
KCCQ is a 23-item instrument that is self-administered. KCCQ measures physical function, symptoms (specifically frequency, severity, and recent change), social function, self-efficacy and knowledge, and quality of life. Subscales and Total Score range from 0-100; higher scores show better health status.
Developed and validated by Dr. John Spertus,MD of University of Missouri-Kansas City.
- Change From Baseline in KCCQ - Symptom Stability [ Time Frame: Baseline,1 year ]
KCCQ is a 23-item instrument that is self-administered. KCCQ measures physical function, symptoms (specifically frequency, severity, and recent change), social function, self-efficacy and knowledge, and quality of life. Subscales and Total Score range from 0-100; higher scores show better health status.
Developed and validated by Dr. John Spertus,MD of University of Missouri-Kansas City.
- Change From Baseline in KCCQ - Symptom Frequency [ Time Frame: Baseline,1 year ]
KCCQ is a 23-item instrument that is self-administered. KCCQ measures physical function, symptoms (specifically frequency, severity, and recent change), social function, self-efficacy and knowledge, and quality of life. Subscales and Total Score range from 0-100; higher scores show better health status.
Developed and validated by Dr. John Spertus,MD of University of Missouri-Kansas City.
- Change From Baseline in KCCQ - Symptom Burden [ Time Frame: Baseline,1 year ]
KCCQ is a 23-item instrument that is self-administered. KCCQ measures physical function, symptoms (specifically frequency, severity, and recent change), social function, self-efficacy and knowledge, and quality of life. Subscales and Total Score range from 0-100; higher scores show better health status.
Developed and validated by Dr. John Spertus,MD of University of Missouri-Kansas City.
- Change From Baseline in KCCQ - Total Symptom [ Time Frame: Baseline,1 year ]
KCCQ is a 23-item instrument that is self-administered. KCCQ measures physical function, symptoms (specifically frequency, severity, and recent change), social function, self-efficacy and knowledge, and quality of life. Subscales and Total Score range from 0-100; higher scores show better health status.
Developed and validated by Dr. John Spertus,MD of University of Missouri-Kansas City.
- Change From Baseline in KCCQ - Self Efficacy [ Time Frame: Baseline,1 year ]
KCCQ is a 23-item instrument that is self-administered. KCCQ measures physical function, symptoms (specifically frequency, severity, and recent change), social function, self-efficacy and knowledge, and quality of life. Subscales and Total Score range from 0-100; higher scores show better health status.
Developed and validated by Dr. John Spertus,MD of University of Missouri-Kansas City.
- Change From Baseline in KCCQ - Quality of Life Score [ Time Frame: Baseline,1 year ]
KCCQ is a 23-item instrument that is self-administered. KCCQ measures physical function, symptoms (specifically frequency, severity, and recent change), social function, self-efficacy and knowledge, and quality of life. Subscales and Total Score range from 0-100; higher scores show better health status.
Developed and validated by Dr. John Spertus,MD of University of Missouri-Kansas City.
- Change From Baseline in KCCQ - Social Limitation [ Time Frame: Baseline,1 year ]
KCCQ is a 23-item instrument that is self-administered. KCCQ measures physical function, symptoms (specifically frequency, severity, and recent change), social function, self-efficacy and knowledge, and quality of life. Subscales and Total Score range from 0-100; higher scores show better health status.
Developed and validated by Dr. John Spertus,MD of University of Missouri-Kansas City.
- Change From Baseline in KCCQ - Overall Summary [ Time Frame: Baseline,1 year ]
KCCQ is a 23-item instrument that is self-administered. KCCQ measures physical function, symptoms (specifically frequency, severity, and recent change), social function, self-efficacy and knowledge, and quality of life. Subscales and Total Score range from 0-100; higher scores show better health status.
Developed and validated by Dr. John Spertus,MD of University of Missouri-Kansas City.
- Change From Baseline in KCCQ - Clinical Summary [ Time Frame: Baseline,1 year ]
KCCQ is a 23-item instrument that is self-administered. KCCQ measures physical function, symptoms (specifically frequency, severity, and recent change), social function, self-efficacy and knowledge, and quality of life. Subscales and Total Score range from 0-100; higher scores show better health status.
Developed and validated by Dr. John Spertus,MD of University of Missouri-Kansas City.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Males and females aged ≥18 years
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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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02754518
United States, Illinois | |
University of Chicago Medical Center | |
Chicago, Illinois, United States, 60637 |
Principal Investigator: | Sara Kalantari, MD | University of Chicago |
Documents provided by University of Chicago:
Responsible Party: | University of Chicago |
ClinicalTrials.gov Identifier: | NCT02754518 |
Other Study ID Numbers: |
IRB15-1410 |
First Posted: | April 28, 2016 Key Record Dates |
Results First Posted: | January 29, 2021 |
Last Update Posted: | January 29, 2021 |
Last Verified: | January 2021 |
Heart Failure Heart Diseases Cardiovascular Diseases Valsartan Sacubitril and valsartan sodium hydrate drug combination |
Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action |