DEF-314 Better Accuracy in Ejection Fraction (EF) Assessment With DEFINITY

NCT03571672 | Completed Phase 3 Results FDA Drug

• 1 other identifier: DEF-314
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 9

Brief Summary

This is a Phase 3, prospective, open-label, multicenter study to evaluate Left Ventricular Ejection Fraction (LVEF) measurement accuracy and reproducibility of DEFINITY® contrast-enhanced and unenhanced echocardiography as compared with non-contrast cardiac magnetic resonance imaging (CMR) used as the truth standard.

Conditions

Cardiac Disease

Keywords

Left Ventricular Ejection Fraction; DEFINITY; Enhanced Echocardiogram; Cardiac Magnetic Resonance

Outcome Measures

Primary Outcomes (1)

• Absolute Value of LVEF Percentage Differences From CMR by Blinded Reader

  Demonstrate improvement in accuracy in left ventricular ejection fraction (LVEF) assessment using Definity contrast-enhanced over unenhanced echocardiography by comparing LVEF Percentage Differences from CMR measured by 3 independent blinded image readers.

  Up to 30 days between day of echocardiograms and CMR imaging

Secondary Outcomes (5)

• Secondary Objective 1: Absolute Value of LVEF Percentage Differences From CMR by Blinded Reader for Suboptimal Echocardiograms

  Up to 30 days between day of echocardiograms and CMR imaging

• Secondary Objective 2: Absolute Value LVEF Percentage Differences From CMR Between Blinded Readers

  Up to 30 days between day of echocardiograms and CMR imaging

• Secondary Objective 3: Absolute Value End-Diastolic and Systolic Volume Differences From CMR Between Blinded Readers

  Up to 30 days between day of echocardiograms and CMR imaging

• Secondary Objective 4: Absolute Value of LVEF Percentage Differences From CMR Between Blinded Readers for Suboptimal Echocardiograms

  Up to 30 days between day of echocardiograms and CMR imaging

• Secondary Objective 5: Absolute Value End-Diastolic and Systolic Volume Differences From CMR Between Blinded Readers for Suboptimal Echocardiograms

  Up to 30 days between day of echocardiograms and CMR imaging

Study Arms (1)

DEFINITY

EXPERIMENTAL

Each patient will undergo an unenhanced ultrasound examination and a DEFINITY contrast-enhanced ultrasound

Drug: DEFINITY

Interventions

DEFINITY DRUG

All subjects will receive a single dose of DEFINITY®

DEFINITY

Eligibility Criteria

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

You may qualify if:

• Men and women ≥ 18 years of age in sinus rhythm
• Able to communicate effectively with trial personnel
• Has undergone a 2D Echo with or without contrast obtained within 6 months prior to enrollment (Day 0)
• Has provided signed informed consent after receiving a verbal and written explanation of this clinical trial -

You may not qualify if:

• Female subjects who are pregnant or lactating. All women of child bearing potential \[WOCBP\] must have a negative urine pregnancy test at screening regardless of contraceptive use history.
• Women of child-bearing potential are excluded unless they:
• are post-menopausal defined as amenorrhea ≥ 12 consecutive months, OR
• have undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy), OR
• have been using an adequate and medically approved method of contraception to avoid pregnancy for at least 1 month prior to DEFINITY® dose administration and be willing to continue using the same method for the duration of the study.
• Current illness or pathology that would prevent undergoing investigational product administration due to a significant safety risk to the patient.
• Uncontrolled arterial hypertension (defined as systolic blood pressure ≥ 200 mmHg or diastolic blood pressure ≥ 110 mmHg) or arterial hypotension (defined as systolic blood pressure ≤ 90 mmHg).
• Unstable cardiovascular status defined as:
• myocardial infarction or unstable angina pectoris within 6 months prior to enrollment/DEFINITY® dose administration day
• transient ischemic attack or stroke within 3 months prior to DEFINITY® dose administration
• symptomatic valvular heart disease or moderate to severe stenotic valvular heart disease
• clinically significant congenital heart defects
• current uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise
• acute pulmonary embolus or pulmonary infarction
• acute myocarditis or pericarditis

Sponsors & Collaborators

• Lantheus Medical Imaging: lead
• Syneos Health: collaborator

Study Sites (9)

Banner University of Arizona Medical Center

Tucson, Arizona, 85724, United States

Location

University of California-San Diego

San Diego, California, 92037, United States

Location

Alfieri Cardiology

Wilmington, Delaware, 19803, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48208, United States

Location

Weill Cornell Medical Center

New York, New York, 10021, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

University Hospital/Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

West Virginia University Medical Center

Morgantown, West Virginia, 26505, United States

Location

MeSH Terms

Conditions

Heart Diseases

Interventions

perflutren

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Results Point of Contact

• Title: Istvan Molnar
• Organization: Lantheus Medical Imaging, Inc

istvan.molnar@lantheus.com

978-671-8686

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2018
• First Posted: June 27, 2018
• Study Start: October 24, 2018
• Primary Completion: August 30, 2019
• Study Completion: August 30, 2019
• Last Updated: December 17, 2020
• Results First Posted: December 17, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)