Demonstration of Reverse Remodeling Effects of Entresto (Valsartan/Sacubitril) Using Echocardiography Endocardial Surface Analysis
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/29/2016 |
| Start Date: | April 2016 |
| End Date: | April 2019 |
| Contact: | Sarah Tayazime |
| Email: | stayazime@uchicago.edu |
| Phone: | (773) 702-9396 |
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.
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.
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)
We found this trial at
1
site
5841 S Maryland Ave
Chicago, Illinois 60637
Chicago, Illinois 60637
(773) 702-1000
Principal Investigator: Nir Uriel, MD
Phone: 773-702-9396
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
Click here to add this to my saved trials
