Ultrasound for Muscle Changes in Heart Failure
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores changes in muscle thickness in individuals with severe heart failure undergoing advanced treatments, such as heart transplants or heart pumps. The researchers aim to understand how muscle mass changes during and after these treatments and its impact on recovery and quality of life. Participants must have heart failure with specific symptoms, such as low blood pressure and the need for heart support devices. The study uses ultrasound imaging to track muscle changes, offering insights into recovery during critical illness.
As an unphased trial, this study provides participants the chance to contribute to valuable insights that could enhance recovery and quality of life for future patients.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this ultrasound technique is safe for assessing skeletal muscle mass?
Research has shown that the BodyMetrix Body Composition Ultrasound is safe. This device uses low-frequency sound waves, which the FDA has approved for similar uses, ensuring safety for people. Studies have found it accurately measures body fat percentage, making it a reliable tool for assessing body composition. No reports of negative effects have emerged, so users find it easy to tolerate.12345
Why are researchers excited about this trial?
Researchers are excited about this trial because it explores changes in skeletal muscle thickness in patients with acute heart failure, offering potential insights that differ from standard treatments like diuretics, ACE inhibitors, and beta-blockers. Unlike these existing options that primarily focus on managing symptoms and improving heart function, this trial aims to understand the relationship between muscle health and heart failure outcomes. By examining skeletal muscle thickness, researchers hope to uncover new strategies for improving overall patient health and recovery, potentially leading to innovative therapeutic approaches that complement existing treatments.
What evidence suggests that this ultrasound method is effective for assessing muscle mass changes in heart failure patients?
Research has shown that the BodyMetrix Body Composition Ultrasound, used by participants in this trial, reliably measures body fat. This device provides results similar to the DEXA method, a trusted way to assess body composition. Studies have found that the ultrasound consistently measures fat thickness, though it may be less accurate for muscle thickness in older adults. Thus, the BodyMetrix ultrasound is useful for checking body composition, aiding in the evaluation of muscle changes in patients with acute heart failure. While it does not directly measure heart failure treatment effectiveness, it offers important information about body changes that could impact recovery and quality of life.24678
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Baseline ultrasound muscle thickness assessments are conducted after consent
Observation
Participants undergo ultrasound muscle thickness assessments on days 3 and 7, then weekly until discharge or death
Follow-up
Participants are monitored for changes in skeletal muscle thickness and clinical outcomes after advanced therapies
What Are the Treatments Tested in This Trial?
Interventions
- BodyMetrix Body Composition Ultrasound
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
All enrolled participants with no randomization group allocations
Find a Clinic Near You
Who Is Running the Clinical Trial?
Tufts Medical Center
Lead Sponsor
Citations
Validity and Reliability of A-Mode Ultrasound for Body ...
This study evaluated the validity and reliability of the BodyMetrix™ BX2000 A-mode ultrasound for estimating percent body fat (%BF) in ...
Reliability of body composition assessment using A-mode ...
Several studies have addressed the validity of ultrasound (US) for body composition assessment, but few have evaluated its reliability.
Validity of the Portable Ultrasound BodyMetrix™ BX-2000 ...
The study shows the BodyMetrix™ BX-2000 provides reasonably good estimates of body fat percentage, comparable to the gold standard DEXA method.
Intra- and inter-rater reliability of muscle and fat thickness ...
Portable ultrasound has excellent reliability for fat thickness, but only moderate for muscle thickness in older adults.
A Decade of Progress in Ultrasound Assessments ...
Seven-site versus three-site method of body composition using BodyMetrix ultrasound compared to dual-energy X-ray absorptiometry. Clin. Physiol. Funct ...
PAGC, I6 F 510(k) Summary - accessdata.fda.gov
BodyMetrix BX2000 and its predicate devices are all devices that use low frequency, ultrasound, and are safe for this application. The ...
7.
digitalcommons.csp.edu
digitalcommons.csp.edu/cgi/viewcontent.cgi?article=1039&context=kinesiology_masters_scienceComparison of the accuracy of the BodyMetrixTM Ultrasound ...
The BIA is a less expensive device, however, is influenced by factors such as hydration levels, recent exercise, and food intake, making it less ...
Reliability of body composition assessment using A-mode ...
Several studies have addressed the validity of ultrasound (US) for body composition assessment, but few have evaluated its reliability.
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