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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
University of Chicago Medical Center
Chicago, Illinois, United States
Change From Baseline in LV Remodeling 2D End-Diastolic Diameter (cm)
LV Remodeling 2D End-Diastolic Diameter (cm)
Time frame: Baseline,1 year
Change From Baseline in LV Remodeling 2D End-Systolic Diameter (cm)
LV Remodeling 2D End-Systolic Diameter (cm)
Time frame: Baseline,1 year
Change From Baseline in LV Remodeling Global Longitudinal Strain (%)
LV Remodeling Global Longitudinal Strain (%)
Time frame: Baseline,1 year
Change From Baseline in LV Remodeling Left Atrial Volume (mL)
LV Remodeling Left Atrial Volume (mL)
Time frame: Baseline,1 year
Change From Baseline in LV Remodeling 3D End-Diastolic Volume (mL)
LV Remodeling 3D End-Diastolic Volume (mL)
Time frame: Baseline,1 year
Change From Baseline in LV Remodeling 3D End-Systolic Volume (mL)
LV Remodeling 3D End-Systolic Volume (mL)
Time frame: Baseline,1 year
Change From Baseline in LV Remodeling LV Ejection Fraction (%)
LV Remodeling LV Ejection Fraction (%)
Time frame: Baseline,1 year
Change From Baseline in LV Remodeling Conicity (%)
LV Remodeling Conicity (%)
Time frame: Baseline,1 year
Change From Baseline in LV Remodeling Sphericity (%)
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LV Remodeling Sphericity (%)
Time frame: Baseline,1 year
Change From Baseline in RV Remodeling End-Diastolic Volume (mL)
RV Remodeling End-Diastolic Volume (mL)
Time frame: Baseline,1 year
Change From Baseline in RV Remodeling End Systolic Volume (mL)
RV Remodeling End Systolic Volume (mL)
Time frame: Baseline,1 year
Change From Baseline in RV Remodeling Ejection Fraction (%)
RV Remodeling Ejection Fraction (%)
Time frame: Baseline,1 year
Change From Baseline in RV Remodeling Septal Curvature (%)
RV Remodeling Septal Curvature (%)
Time frame: Baseline,1 year
Change From Baseline in RV Remodeling Free-Wall Curvature (%)
RV Remodeling Free-Wall Curvature (%)
Time frame: Baseline,1 year
Change From Baseline in RV Remodeling Tricuspid Regurgitation
RV Remodeling Tricuspid Regurgitation
Time frame: Baseline,1 year
Change From Baseline in Rho-associated Protein Kinase (ROCK)
Rho-associated protein kinase (ROCK)
Time frame: Baseline,1 year
Change From Baseline in (MIBG) Early hm Ratio
Cardiac 123Iodine-metaiodobenzylguanidine (MIBG) Early heart/mediastinum ratio (hm) ratio
Time frame: Baseline,1 year
Change From Baseline in (MIBG) Late hm Ratio
Cardiac 123Iodine-metaiodobenzylguanidine (MIBG) Late heart/mediastinum ratio (hm) ratio
Time frame: Baseline,1 year
Change From Baseline in NT-proBNP Levels
NT-proBNP levels (pg/ml)
Time frame: Baseline,1 year
Change From Baseline in Exercise Performance - 6 Minute Walk
Exercise Performance - 6 Minute Walk
Time frame: Baseline,1 year
Change From Baseline in Exercise Performance - CPX - Peak VO2 (mL/kg/Min)
Exercise Performance - CPX - Peak VO2 (mL/kg/min)
Time frame: Baseline,1 year
Change From Baseline in Exercise Performance - CPX - Peak RER
Exercise Performance - CPX - Peak RER (Respiratory Exchange Ratio)
Time frame: Baseline,1 year
Change From Baseline in Exercise Performance - CPX - VE/VC02
Exercise Performance - CPX - VE/VC02
Time frame: Baseline,1 year
Change From Baseline in Blood Pressure - Systolic (mmHg)
Blood Pressure - Systolic (mmHg)
Time frame: Baseline,1 year
Change From Baseline in Blood Pressure - Diastolic (mmHg)
Blood Pressure - Diastolic (mmHg)
Time frame: Baseline,1 year
Change From Baseline in KCCQ - Physical Limitation
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.
Time frame: Baseline,1 year
Change From Baseline in KCCQ - Symptom Stability
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.
Time frame: Baseline,1 year
Change From Baseline in KCCQ - Symptom Frequency
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.
Time frame: Baseline,1 year
Change From Baseline in KCCQ - Symptom Burden
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.
Time frame: Baseline,1 year
Change From Baseline in KCCQ - Total Symptom
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.
Time frame: Baseline,1 year
Change From Baseline in KCCQ - Self Efficacy
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.
Time frame: Baseline,1 year
Change From Baseline in KCCQ - Quality of Life Score
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.
Time frame: Baseline,1 year
Change From Baseline in KCCQ - Social Limitation
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.
Time frame: Baseline,1 year
Change From Baseline in KCCQ - Overall Summary
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.
Time frame: Baseline,1 year
Change From Baseline in KCCQ - Clinical Summary
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.
Time frame: Baseline,1 year