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DEF-314 Better Accuracy in Ejection Fraction (EF) Assessment With DEFINITY (BENEFIT1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03571672
Recruitment Status : Completed
First Posted : June 27, 2018
Results First Posted : December 17, 2020
Last Update Posted : December 17, 2020
Sponsor:
Collaborator:
Syneos Health
Information provided by (Responsible Party):
Lantheus Medical Imaging

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.

Condition or disease Intervention/treatment Phase
Cardiac Disease Drug: DEFINITY Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 153 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Phase III, Open-Label, Multicenter Trial to Evaluate Ejection Fraction, End-Diastolic and End-Systolic Volumes, by Unenhanced and DEFINITY®-Enhanced 2D-Echo and Magnetic Resonance Imaging
Actual Study Start Date : October 24, 2018
Actual Primary Completion Date : August 30, 2019
Actual Study Completion Date : August 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Perflutren

Arm Intervention/treatment
Experimental: DEFINITY
Each patient will undergo an unenhanced ultrasound examination and a DEFINITY contrast-enhanced ultrasound
Drug: DEFINITY
All subjects will receive a single dose of DEFINITY®




Primary Outcome Measures :
  1. Absolute Value of LVEF Percentage Differences From CMR by Blinded Reader [ Time Frame: Up to 30 days between day of echocardiograms and CMR imaging ]
    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.


Secondary Outcome Measures :
  1. Secondary Objective 1: Absolute Value of LVEF Percentage Differences From CMR by Blinded Reader for Suboptimal Echocardiograms [ Time Frame: Up to 30 days between day of echocardiograms and CMR imaging ]
    Demonstrate improvement in accuracy in left ventricular ejection fraction (LVEF) assessment using DEFINITY® contrast-enhanced over unenhanced echocardiography in subjects with suboptimal echocardiograms by comparing LVEF percentage differences from CMR measured by 3 independent readers.

  2. Secondary Objective 2: Absolute Value LVEF Percentage Differences From CMR Between Blinded Readers [ Time Frame: Up to 30 days between day of echocardiograms and CMR imaging ]
    Demonstrate a reduction in inter-reader variability for the assessment of left ventricular ejection fraction using DEFINITY® contrast-enhanced versus unenhanced echocardiography by comparing LVEF Percentage Differences from CMR between 3 independent blinded readers

  3. Secondary Objective 3: Absolute Value End-Diastolic and Systolic Volume Differences From CMR Between Blinded Readers [ Time Frame: Up to 30 days between day of echocardiograms and CMR imaging ]
    Demonstrate a reduction in inter-reader variability for the assessment of end-diastolic and systolic volumes using DEFINITY® contrast-enhanced versus unenhanced echocardiography by comparing end-diastolic and systolic volume differences from CMR between 3 independent blinded readers.

  4. Secondary Objective 4: Absolute Value of LVEF Percentage Differences From CMR Between Blinded Readers for Suboptimal Echocardiograms [ Time Frame: Up to 30 days between day of echocardiograms and CMR imaging ]
    Demonstrate a reduction in inter-reader variability for the assessment of left ventricular ejection fraction using DEFINITY® contrast-enhanced versus unenhanced echocardiography by comparing LVEF Percentage Differences from CMR between 3 independent blinded readers in subjects with suboptimal echocardiograms.

  5. Secondary Objective 5: Absolute Value End-Diastolic and Systolic Volume Differences From CMR Between Blinded Readers for Suboptimal Echocardiograms [ Time Frame: Up to 30 days between day of echocardiograms and CMR imaging ]
    Demonstrate a reduction in inter-reader variability for the assessment of end-diastolic/systolic volumes using DEFINITY® contrast-enhanced versus unenhanced echocardiography by comparing end-diastolic and systolic volume differences from CMR between 3 independent blinded readers in subjects with suboptimal echocardiograms.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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.
  2. Women of child-bearing potential are excluded unless they:

    1. are post-menopausal defined as amenorrhea ≥ 12 consecutive months, OR
    2. have undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy), OR
    3. 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.
  3. Current illness or pathology that would prevent undergoing investigational product administration due to a significant safety risk to the patient.
  4. 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).
  5. Unstable cardiovascular status defined as:

    1. myocardial infarction or unstable angina pectoris within 6 months prior to enrollment/DEFINITY® dose administration day
    2. transient ischemic attack or stroke within 3 months prior to DEFINITY® dose administration
    3. symptomatic valvular heart disease or moderate to severe stenotic valvular heart disease
    4. clinically significant congenital heart defects
    5. current uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise
    6. acute pulmonary embolus or pulmonary infarction
    7. acute myocarditis or pericarditis
    8. acute aortic dissection
    9. atrial fibrillation
  6. any major surgery within 4 weeks prior to screening
  7. known contraindications to undergoing CMR or claustrophobia
  8. participation in any investigational drug, device, or placebo study within 30 days prior to screening
  9. known hypersensitivity to perflutren, or any of the excipients in DEFINITY®
  10. prisoners or those who are subject to compulsory detention or involuntary incarceration for treatment of either a psychiatric or physical illness (e.g., infectious disease) -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03571672


Locations
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United States, Arizona
Banner University of Arizona Medical Center
Tucson, Arizona, United States, 85724
United States, California
University of California-San Diego
San Diego, California, United States, 92037
United States, Delaware
Alfieri Cardiology
Wilmington, Delaware, United States, 19803
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48208
United States, New York
Weill Cornell Medical Center
New York, New York, United States, 10021
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
United States, Ohio
University Hospital/Cleveland Medical Center
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, West Virginia
West Virginia University Medical Center
Morgantown, West Virginia, United States, 26505
Sponsors and Collaborators
Lantheus Medical Imaging
Syneos Health
  Study Documents (Full-Text)

Documents provided by Lantheus Medical Imaging:
Study Protocol  [PDF] August 15, 2018
Statistical Analysis Plan  [PDF] October 6, 2018

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Responsible Party: Lantheus Medical Imaging
ClinicalTrials.gov Identifier: NCT03571672    
Other Study ID Numbers: DEF-314
First Posted: June 27, 2018    Key Record Dates
Results First Posted: December 17, 2020
Last Update Posted: December 17, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lantheus Medical Imaging:
Left Ventricular Ejection Fraction
DEFINITY
Enhanced Echocardiogram
Cardiac Magnetic Resonance
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases