Clinical Trials Logo

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

NCT number NCT03948776
Study type Observational
Source Tufts Medical Center
Contact Amanda R Vest, MBBS, MPH
Phone 617-636-8068
Status Recruiting
Start date May 2019
Completion date July 2021

See also
  Status Clinical Trial Phase
Recruiting NCT03615469 - Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY) N/A
Active, not recruiting NCT03549169 - Decision Making for the Management the Symptoms in Adults of Heart Failure N/A
Withdrawn NCT03091998 - Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support Phase 1
Recruiting NCT03300791 - Predictive Models of Readmission in Heart Failure N/A
Completed NCT03294512 - Pilot and Feasibility Study of a MAWDS (Medications, Activity, Weight, Diet and Symptoms) Heart Failure Mobile Platform N/A
Recruiting NCT03565328 - The Effect of Nicotinamide Riboside on Skeletal Muscle Function in Heart Failure Subjects Phase 2
Recruiting NCT03560167 - Early Feasibility Study of the AccuCinch® Ventricular Repair System in Patients With Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation - The CorCinch-PMVI Study N/A
Active, not recruiting NCT03281122 - A Study of BMS-986224 in Healthy Subjects and Heart Failure Patients With Reduced Ejection Fraction Phase 1
Recruiting NCT02275819 - Exercise Training in Heart Failure: Changes in Cardiac Structure and Function
Completed NCT03238729 - Proof-of-Concept Study of Heart Habits Application for Patients With Heart Failure N/A
Not yet recruiting NCT02784912 - Biomarkers in Risk Stratification of Sustainted Ventricular Tachycardia or Electrical Storm After Ablation N/A
Recruiting NCT02877914 - China PEACE 5r-HF Study N/A
Recruiting NCT02922478 - Role of Comorbidities in Chronic Heart Failure Study
Recruiting NCT02674438 - Comparison of Outcomes and Access to Care for Heart Failure Trial Phase 3
Recruiting NCT02713126 - Inorganic Nitrite to Amplify the Benefits and Tolerability of Exercise Training in Heart Failure With Preserved Ejection Fraction (HFpEF) (INABLE-Training) Phase 2
Recruiting NCT02823795 - The Supporting Patient Activation in Transition to Home Intervention N/A
Recruiting NCT03013270 - Aerobic, Resistance, Inspiratory Training Outcomes in Heart Failure N/A
Active, not recruiting NCT02911493 - Reducing Sedentary Time in Patients With Heart Failure N/A
Completed NCT02921607 - Development of Scalable New Model(s) Focused on Care Co-ordination and Care Provision for Medically Complex, Co-morbid Chronic Disease Patient Segments Focusing on Heart Failure
Withdrawn NCT02624960 - Safety and Performance of the AccuCinch® System N/A