Heart FailurePhase 4NCT02754518
Demonstration of Reverse Remodeling Effects of Entresto. Using Echocardiography Endocardial Surface Analysis
A Phase 4 study testing Entresto in people with Heart Failure, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Entresto
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Apr 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Medical Center
Chicago, Illinois, 60637
About this study
Official title: Demonstration of Reverse Remodeling Effects of Entresto (Valsartan/Sacubitril) 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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Entresto
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EntrestoDrug
Also called valsartan/sacubitril
| Study group | Role | What they receive |
|---|---|---|
| Open label Entresto | Other | 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. Receives: Drug: Entresto |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in LV Remodeling 2D End-Diastolic Diameter (cm)
LV Remodeling 2D End-Diastolic Diameter (cm)
Measured: Baseline,1 year
Change From Baseline in LV Remodeling 2D End-Systolic Diameter (cm)
LV Remodeling 2D End-Systolic Diameter (cm)
Measured: Baseline,1 year
Change From Baseline in LV Remodeling Global Longitudinal Strain (%)
LV Remodeling Global Longitudinal Strain (%)
Measured: Baseline,1 year
Change From Baseline in LV Remodeling Left Atrial Volume (mL)
LV Remodeling Left Atrial Volume (mL)
Measured: Baseline,1 year
Change From Baseline in LV Remodeling 3D End-Diastolic Volume (mL)
LV Remodeling 3D End-Diastolic Volume (mL)
Measured: Baseline,1 year
Change From Baseline in LV Remodeling 3D End-Systolic Volume (mL)
LV Remodeling 3D End-Systolic Volume (mL)
Measured: Baseline,1 year
Change From Baseline in LV Remodeling LV Ejection Fraction (%)
LV Remodeling LV Ejection Fraction (%)
Measured: Baseline,1 year
Change From Baseline in LV Remodeling Conicity (%)
LV Remodeling Conicity (%)
Measured: Baseline,1 year
Change From Baseline in LV Remodeling Sphericity (%)
LV Remodeling Sphericity (%)
Measured: Baseline,1 year
Change From Baseline in RV Remodeling End-Diastolic Volume (mL)
RV Remodeling End-Diastolic Volume (mL)
Measured: Baseline,1 year
Change From Baseline in RV Remodeling End Systolic Volume (mL)
RV Remodeling End Systolic Volume (mL)
Measured: Baseline,1 year
Change From Baseline in RV Remodeling Ejection Fraction (%)
RV Remodeling Ejection Fraction (%)
Measured: Baseline,1 year
Change From Baseline in RV Remodeling Septal Curvature (%)
RV Remodeling Septal Curvature (%)
Measured: Baseline,1 year
Change From Baseline in RV Remodeling Free-Wall Curvature (%)
RV Remodeling Free-Wall Curvature (%)
Measured: Baseline,1 year
Change From Baseline in RV Remodeling Tricuspid Regurgitation
RV Remodeling Tricuspid Regurgitation
Measured: Baseline,1 year
Secondary outcomes (20)
Change From Baseline in Rho-associated Protein Kinase (ROCK)
Rho-associated protein kinase (ROCK)
Measured: Baseline,1 year
Change From Baseline in (MIBG) Early hm Ratio
Cardiac 123Iodine-metaiodobenzylguanidine (MIBG) Early heart/mediastinum ratio (hm) ratio
Measured: Baseline,1 year
Change From Baseline in (MIBG) Late hm Ratio
Cardiac 123Iodine-metaiodobenzylguanidine (MIBG) Late heart/mediastinum ratio (hm) ratio
Measured: Baseline,1 year
Change From Baseline in NT-proBNP Levels
NT-proBNP levels (pg/ml)
Measured: Baseline,1 year
Change From Baseline in Exercise Performance - 6 Minute Walk
Exercise Performance - 6 Minute Walk
Measured: Baseline,1 year
Change From Baseline in Exercise Performance - CPX - Peak VO2 (mL/kg/Min)
Exercise Performance - CPX - Peak VO2 (mL/kg/min)
Measured: Baseline,1 year
Change From Baseline in Exercise Performance - CPX - Peak RER
Exercise Performance - CPX - Peak RER (Respiratory Exchange Ratio)
Measured: Baseline,1 year
Change From Baseline in Exercise Performance - CPX - VE/VC02
Exercise Performance - CPX - VE/VC02
Measured: Baseline,1 year
Change From Baseline in Blood Pressure - Systolic (mmHg)
Blood Pressure - Systolic (mmHg)
Measured: Baseline,1 year
Change From Baseline in Blood Pressure - Diastolic (mmHg)
Blood Pressure - Diastolic (mmHg)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline,1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2019
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara Kalantari, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02754518
- Sponsor's protocol ID
- IRB15-1410
- Status last verified
- Jan 2021
- First submitted
- 22 Apr 2016
- Last updated
- 29 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demonstration of Reverse Remodeling Effects of Entresto (Valsartan/Sacubitril) Using Echocardiography Endocardial Surface Analysis
- ClinicalTrials.gov ID
- NCT02754518
- Acronym / sponsor ID
- IRB15-1410
- Conditions
- Heart Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 28 Apr 2016 (estimated)
- Results
- Posted 29 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open label Entresto | Other | Drug: EntrestoAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EntrestoAlso: valsartan/sacubitril | Drug | Open label Entresto |
Primary outcome
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
20 secondary outcomes
Change From Baseline in Rho-associated Protein Kinase (ROCK)
Time frame: Baseline,1 year
Change From Baseline in (MIBG) Early hm Ratio
Time frame: Baseline,1 year
Change From Baseline in (MIBG) Late hm Ratio
Time frame: Baseline,1 year
Change From Baseline in NT-proBNP Levels
Time frame: Baseline,1 year
Change From Baseline in Exercise Performance - 6 Minute Walk
Time frame: Baseline,1 year
Change From Baseline in Exercise Performance - CPX - Peak VO2 (mL/kg/Min)
Time frame: Baseline,1 year
Change From Baseline in Exercise Performance - CPX - Peak RER
Time frame: Baseline,1 year
Change From Baseline in Exercise Performance - CPX - VE/VC02
Time frame: Baseline,1 year
Change From Baseline in Blood Pressure - Systolic (mmHg)
Time frame: Baseline,1 year
Change From Baseline in Blood Pressure - Diastolic (mmHg)
Time frame: Baseline,1 year
Change From Baseline in KCCQ - Physical Limitation
Time frame: Baseline,1 year
Change From Baseline in KCCQ - Symptom Stability
Time frame: Baseline,1 year
Change From Baseline in KCCQ - Symptom Frequency
Time frame: Baseline,1 year
Change From Baseline in KCCQ - Symptom Burden
Time frame: Baseline,1 year
Change From Baseline in KCCQ - Total Symptom
Time frame: Baseline,1 year
Change From Baseline in KCCQ - Self Efficacy
Time frame: Baseline,1 year
Change From Baseline in KCCQ - Quality of Life Score
Time frame: Baseline,1 year
Change From Baseline in KCCQ - Social Limitation
Time frame: Baseline,1 year
Change From Baseline in KCCQ - Overall Summary
Time frame: Baseline,1 year
Change From Baseline in KCCQ - Clinical Summary
Time frame: Baseline,1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Kalantari, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Entresto in people with Heart Failure, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in LV Remodeling 2D End-Diastolic Diameter (cm) (time frame: Baseline,1 year). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2021.