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Completed

NCT Number: NCT02754518

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Entresto

Drug

Other names: valsartan/sacubitril

Primary outcomes

  1. Change From Baseline in LV Remodeling 2D End-Diastolic Diameter (cm)

    Time frame: Baseline,1 year

    LV Remodeling 2D End-Diastolic Diameter (cm)

  2. Change From Baseline in LV Remodeling 2D End-Systolic Diameter (cm)

    Time frame: Baseline,1 year

    LV Remodeling 2D End-Systolic Diameter (cm)

  3. Change From Baseline in LV Remodeling Global Longitudinal Strain (%)

    Time frame: Baseline,1 year

    LV Remodeling Global Longitudinal Strain (%)

  4. Change From Baseline in LV Remodeling Left Atrial Volume (mL)

    Time frame: Baseline,1 year

    LV Remodeling Left Atrial Volume (mL)

  5. Change From Baseline in LV Remodeling 3D End-Diastolic Volume (mL)

    Time frame: Baseline,1 year

    LV Remodeling 3D End-Diastolic Volume (mL)

  6. Change From Baseline in LV Remodeling 3D End-Systolic Volume (mL)

    Time frame: Baseline,1 year

    LV Remodeling 3D End-Systolic Volume (mL)

  7. Change From Baseline in LV Remodeling LV Ejection Fraction (%)

    Time frame: Baseline,1 year

    LV Remodeling LV Ejection Fraction (%)

  8. Change From Baseline in LV Remodeling Conicity (%)

    Time frame: Baseline,1 year

    LV Remodeling Conicity (%)

  9. Change From Baseline in LV Remodeling Sphericity (%)

    Time frame: Baseline,1 year

    LV Remodeling Sphericity (%)

  10. Change From Baseline in RV Remodeling End-Diastolic Volume (mL)

    Time frame: Baseline,1 year

    RV Remodeling End-Diastolic Volume (mL)

  11. Change From Baseline in RV Remodeling End Systolic Volume (mL)

    Time frame: Baseline,1 year

    RV Remodeling End Systolic Volume (mL)

  12. Change From Baseline in RV Remodeling Ejection Fraction (%)

    Time frame: Baseline,1 year

    RV Remodeling Ejection Fraction (%)

  13. Change From Baseline in RV Remodeling Septal Curvature (%)

    Time frame: Baseline,1 year

    RV Remodeling Septal Curvature (%)

  14. Change From Baseline in RV Remodeling Free-Wall Curvature (%)

    Time frame: Baseline,1 year

    RV Remodeling Free-Wall Curvature (%)

  15. Change From Baseline in RV Remodeling Tricuspid Regurgitation

    Time frame: Baseline,1 year

    RV Remodeling Tricuspid Regurgitation

Secondary outcomes

  1. Change From Baseline in Rho-associated Protein Kinase (ROCK)

    Time frame: Baseline,1 year

    Rho-associated protein kinase (ROCK)

  2. Change From Baseline in (MIBG) Early hm Ratio

    Time frame: Baseline,1 year

    Cardiac 123Iodine-metaiodobenzylguanidine (MIBG) Early heart/mediastinum ratio (hm) ratio

  3. Change From Baseline in (MIBG) Late hm Ratio

    Time frame: Baseline,1 year

    Cardiac 123Iodine-metaiodobenzylguanidine (MIBG) Late heart/mediastinum ratio (hm) ratio

  4. Change From Baseline in NT-proBNP Levels

    Time frame: Baseline,1 year

    NT-proBNP levels (pg/ml)

  5. Change From Baseline in Exercise Performance - 6 Minute Walk

    Time frame: Baseline,1 year

    Exercise Performance - 6 Minute Walk

  6. 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)

  7. Change From Baseline in Exercise Performance - CPX - Peak RER

    Time frame: Baseline,1 year

    Exercise Performance - CPX - Peak RER (Respiratory Exchange Ratio)

  8. Change From Baseline in Exercise Performance - CPX - VE/VC02

    Time frame: Baseline,1 year

    Exercise Performance - CPX - VE/VC02

  9. Change From Baseline in Blood Pressure - Systolic (mmHg)

    Time frame: Baseline,1 year

    Blood Pressure - Systolic (mmHg)

  10. Change From Baseline in Blood Pressure - Diastolic (mmHg)

    Time frame: Baseline,1 year

    Blood Pressure - Diastolic (mmHg)

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 28, 2016
Registry last updated
Jan 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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