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Body Composition Ultrasound for Patients With Heart Failure

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: NCT03948776
Recruitment Status : Suspended (COVID-19)
First Posted : May 14, 2019
Last Update Posted : April 6, 2020
Sponsor:
Information provided by (Responsible Party):
Tufts Medical Center

Tracking Information
First Submitted Date May 10, 2019
First Posted Date May 14, 2019
Last Update Posted Date April 6, 2020
Actual Study Start Date May 24, 2019
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 16, 2019)
  • Primary DXA endpoint: fat free mass (FFM) measured by DXA [ Time Frame: On study day 1 ]
    This is the fat free mass calculated by whole-body DXA, which is the gold standard for measuring skeletal muscle mass
  • Primary ultrasound endpoint: FFM measured by BodyMetrix ultrasound [ Time Frame: On study day 1 ]
    This is the muscle mass estimation from the BodyMetrix ultrasound device which the investigators are seeking to validate as a method of body composition assessment
Original Primary Outcome Measures
 (submitted: May 10, 2019)
  • Primary DXA endpoint: fat free mass (FFM) measured by DXA [ Time Frame: At time of study visit ]
    This is the fat free mass calculated by whole-body DXA, which is the gold standard for measuring skeletal muscle mass
  • Primary ultrasound endpoint: FFM measured by BodyMetrix ultrasound [ Time Frame: At time of study visit ]
    This is the muscle mass estimation from the BodyMetrix ultrasound device which we are seeking to validate as a method of body composition assessment
Change History
Current Secondary Outcome Measures
 (submitted: May 16, 2019)
  • Handgrip strength [ Time Frame: On study day 1 ]
    Average of 3 handgrip strength measurements in the dominant upper extremity
  • Sit-to-stand test [ Time Frame: On study day 1 ]
    Time (in seconds) for the participant complete 5 sit-to-stands, starting in a seated position on a chair
Original Secondary Outcome Measures
 (submitted: May 10, 2019)
  • Handgrip strength [ Time Frame: At time of study visit ]
    Average of 3 handgrip strength measurements in the dominant upper extremity
  • Sit-to-stand test [ Time Frame: At time of study visit ]
    Time (in seconds) for the participant complete 5 sit-to-stands, starting in a seated position on a chair
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Body Composition Ultrasound for Patients With Heart Failure
Official Title Validation of Body Composition Ultrasound for Identification of Sarcopenia and Cachexia in Patients With Heart Failure
Brief Summary This study aims to determine whether skeletal muscle ultrasound is a useful technique for measuring low muscle mass in patients with heart failure (HF). Muscle wasting and abnormal muscle quality has been identified in patients with advanced HF and may contribute to patients' physical limitations. However assessments of body composition for patients with HF currently rely on the research tool of dual X-ray absorptiometry (DXA) for measurements of skeletal muscle mass, which is limited by cost, use of radiation, and the need for patients to be transported to the DXA scanner for imaging. Therefore this observational study is designed to validate a new approach that allows a safe and portable assessment of body composition.
Detailed Description

The investigators will be recruiting both healthy subjects without HF, as well as subjects with either HF, a left ventricular assist device (LVAD) or cardiac transplantation. This is an observational study to validate the use of the BodyMetrix BX 2000 Pro ultrasound machine for the assessment of body composition, particularly muscle wasting. The ultrasound device received 501(k) designation from the FDA in 2009 for measurement of localized fat and muscle thickness. Participation will last for only one day, with approximately 2 hours of study activity in total:

  1. For woman with child-bearing potential, potential participants will be required to undergo a urine pregnancy test prior to DXA imaging.
  2. The investigators will record participant age, sex, height, weight and heart failure status.
  3. Muscle ultrasound: investigators will make measurements at 7 positions on the arm, chest wall, and leg (participant's dominant side). Clear ultrasound gel will be applied to the skin, a BodyMetrix ultrasound probe placed against the skin, and the muscle thickness measurement made five times at each position. The gel is then wiped away.
  4. Whole body dual X-ray absorptiometry (DXA) scan: the DXA scan involves lying on a flat and open scanner for approximately 5 minutes while an X-ray arm passes over the body to form a picture for whole body composition.
  5. Handgrip strength: this involves the participant squeezing a handheld machine on three occasions in the dominant hand to measure grip strength.
  6. 5 sit-to-stand test: investigators will time how long it takes for the participant to stand up from a seated position five times to assess lower body strength.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population

Three study populations will be recruited for this observational validation study:

Cohort 1: Healthy volunteers Cohort 2: Participants in our existing left ventricular assist device (LVAD) body composition study (#12026) who consent to undergo skeletal muscle ultrasound the same day as an LVAD body composition study visit that already includes the DXA and handgrip strength procedures Cohort 3: Patients with heart failure, an LVAD or heart transplantation Cohort 4: Inpatients with heart failure, an LVAD or heart transplantation, currently admitted to Tufts Medical Center

Condition Heart Failure
Intervention
  • Diagnostic Test: BodyMetrix body composition ultrasound
    Investigators will make ultrasound measurements of fat and muscle thickness at 7 positions on the arm, chest wall, and leg (subject's dominant side) using the BodyMetrix BX 2000 ultrasound machine. Clear ultrasound gel will be applied to the skin, a probe placed against the skin, and the fat/muscle thickness measurement made five times at each position. The gel is then wiped away. The images are analyzed by the BodyView Software and estimations of fat and muscle mass calculated. These will be compared to the reference technique of whole-body DXA imaging.
  • Diagnostic Test: BodyMetrix body composition ultrasound only
    Investigators will make ultrasound measurements of fat and muscle thickness at 7 positions on the arm, chest wall, and leg (subject's dominant side) using the BodyMetrix BX 2000 ultrasound machine. Clear ultrasound gel will be applied to the skin, a probe placed against the skin, and the fat/muscle thickness measurement made five times at each position. The gel is then wiped away. The images are analyzed by the BodyView Software and estimations of fat and muscle mass calculated. For inpatients currently admitted to the hospital, whole-body DXA imaging cannot be performed, as so the only assessment of body composition will be with the ultrasound.
Study Groups/Cohorts
  • Healthy volunteers
    Adults without HF or prior heart transplantation
    Intervention: Diagnostic Test: BodyMetrix body composition ultrasound
  • Participants in our existing LVAD body composition study
    Currently-enrolled LVAD body composition participants, who chose to participate in this study on the same day as a DXA scan already scheduled for study #12026
    Intervention: Diagnostic Test: BodyMetrix body composition ultrasound
  • Patients with heart failure, an LVAD or heart transplantation
    Any patients with a current diagnosis of HF, with or without an LVAD, or prior HF now status post heart transplantation
    Intervention: Diagnostic Test: BodyMetrix body composition ultrasound
  • Inpatients with heart failure, LVAD, heart transplantation
    Patients with a current diagnosis of HF, with or without an LVAD, or prior HF now status post heart transplantation, currently admitted as inpatients at Tufts Medical Center. The 6/20/2019 protocol update includes these patients who will participate without a DXA scan (which can only be performed as an outpatient).
    Intervention: Diagnostic Test: BodyMetrix body composition ultrasound only
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Suspended
Estimated Enrollment
 (submitted: July 2, 2019)
90
Original Estimated Enrollment
 (submitted: May 10, 2019)
60
Estimated Study Completion Date July 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Cohort 1: Healthy volunteers:

    • 18+ years
    • No history of heart failure
    • Not pregnant
    • Willing to take a urinary pregnancy test if there is a possibility of pregnancy
    • Able to freely provide informed consent
  2. Cohort 2: Participants in our existing left ventricular assist device (LVAD) body composition study (#12026) who consent to undergo skeletal muscle ultrasound the same day as an LVAD body composition study visit that already includes the DXA and handgrip strength procedures:

    • Meet the eligibility criteria outlined in study #12026

  3. Cohort 3: Patients with heart failure, an LVAD or heart transplantation

    • 18+ years
    • Not pregnant
    • Willing to take a urinary pregnancy test if there is a possibility of pregnancy

Exclusion Criteria:

  1. Patients requiring temporary mechanical circulatory support
  2. Pregnant women, or women who report there is a possibility they could be pregnant and decline to complete a pregnancy test
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03948776
Other Study ID Numbers 13206
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Tufts Medical Center
Study Sponsor Tufts Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: Amanda R Vest, MBBS, MPH Tufts Medical Center
PRS Account Tufts Medical Center
Verification Date April 2020