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

NCT02754518 | Completed Phase 4 Results

• 1 other identifier: IRB15-1410
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (15)

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

  LV Remodeling 2D End-Diastolic Diameter (cm)

  Baseline,1 year

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

  LV Remodeling 2D End-Systolic Diameter (cm)

  Baseline,1 year

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

  LV Remodeling Global Longitudinal Strain (%)

  Baseline,1 year

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

  LV Remodeling Left Atrial Volume (mL)

  Baseline,1 year

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

  LV Remodeling 3D End-Diastolic Volume (mL)

  Baseline,1 year

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

  LV Remodeling 3D End-Systolic Volume (mL)

  Baseline,1 year

• Change From Baseline in LV Remodeling LV Ejection Fraction (%)

  LV Remodeling LV Ejection Fraction (%)

  Baseline,1 year

• Change From Baseline in LV Remodeling Conicity (%)

  LV Remodeling Conicity (%)

  Baseline,1 year

• Change From Baseline in LV Remodeling Sphericity (%)

  LV Remodeling Sphericity (%)

  Baseline,1 year

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

  RV Remodeling End-Diastolic Volume (mL)

  Baseline,1 year

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

  RV Remodeling End Systolic Volume (mL)

  Baseline,1 year

• Change From Baseline in RV Remodeling Ejection Fraction (%)

  RV Remodeling Ejection Fraction (%)

  Baseline,1 year

• Change From Baseline in RV Remodeling Septal Curvature (%)

  RV Remodeling Septal Curvature (%)

  Baseline,1 year

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

  RV Remodeling Free-Wall Curvature (%)

  Baseline,1 year

• Change From Baseline in RV Remodeling Tricuspid Regurgitation

  RV Remodeling Tricuspid Regurgitation

  Baseline,1 year

Secondary Outcomes (20)

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

  Baseline,1 year

• Change From Baseline in (MIBG) Early hm Ratio

  Baseline,1 year

• Change From Baseline in (MIBG) Late hm Ratio

  Baseline,1 year

• Change From Baseline in NT-proBNP Levels

  Baseline,1 year

• Change From Baseline in Exercise Performance - 6 Minute Walk

  Baseline,1 year

Study Arms (1)

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.

Drug: Entresto

Interventions

Entresto DRUG

Also known as: valsartan/sacubitril

Open label Entresto

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

sacubitril and valsartan sodium hydrate drug combination

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Sara Kalantari, MD
• Organization: University of Chicago

skalantari@medicine.bsd.uchicago.edu

773-834-6853

Study Officials

• Sara Kalantari, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2016
• First Posted: April 28, 2016
• Study Start: April 1, 2016
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: January 29, 2021
• Results First Posted: January 29, 2021

Record last verified: 2021-01

Locations

US (1)