DEF-315 Better Accuracy in Ejection Fraction (EF) Assessment With DEFINITY

NCT03719612 | Completed Phase 3 Results FDA Drug

• 1 other identifier: DEF-315
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 15

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 Sub-optimal Echocardiograms

  Up to 30 days between day of echocardiogram 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 echocardiogram and CMR imaging

• Secondary Objective 4: Absolute Value of LVEF Percentage Differences From CMR Between Readers for Sub-optimal 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
• LVEF measurements obtained via 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 (15)

Banner University of Arizona Medical Center

Tucson, Arizona, 85724, United States

Location

Cedars Sinai

Los Angeles, California, 90048, United States

Location

University of California-Irvine

Orange, California, 92868, United States

Location

UC San Diego

San Diego, California, 92037, United States

Location

Alfieri Cardiology

Wilmington, Delaware, 19803, United States

Location

Northwestern Medical Group

Chicago, Illinois, 60611, United States

Location

Indiana University

Bloomington, Indiana, 46202, United States

Location

Baptist Hospital

Paducah, Kentucky, 42003, United States

Location

Mercy Unit Hospital

Coon Rapids, Minnesota, 55433, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

Location

University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

Location

Oregon Health and Sciences University

Portland, Oregon, 97240, United States

Location

Albert Einstein Medical Center

Philadelphia, Pennsylvania, 19412, United States

Location

Baylor Scott White Research Institute

Temple, Texas, 76501, 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: September 28, 2018
• First Posted: October 25, 2018
• Study Start: December 28, 2018
• Primary Completion: January 9, 2020
• Study Completion: January 9, 2020
• Last Updated: January 28, 2021
• Results First Posted: January 7, 2021

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)