Changes in Skeletal Muscle Thickness in Patients With Acute Heart Failure

NCT ID: NCT06253104

Last Updated: 2025-04-23

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-19
• Study Completion Date: 2026-12-31

Brief Summary

This study aims to determine, via skeletal muscle ultrasound (US), the extent, timing and relationship between skeletal muscle mass loss and outcomes after orthotropic heart transplantation (OHT) and left ventricular assist device (LVAD) implantation amongst patients with cardiogenic shock. Advanced therapies such as OHT and VADs in the heart failure (HF) population may promote skeletal muscle mass and subsequent quality of life, but there is a lack of literature assessing muscle mass changes in HF patients before and after advanced therapies using US imaging. Therefore this observational study will provide further insight into the 1) changes in lean body mass during critical illness and 2) the feasibility of using bedside US to assess lean body mass in the inpatient setting.

Detailed Description

The investigators will be recruiting subjects with advanced cardiomyopathy in cardiogenic shock in the inpatient setting. This is an observational study to better understand changes in lean body mass during critical illness through a quick, safe, and non-invasive method. This study will also validate the use of the BodyMetrix BX 2000 Pro ultrasound machine for the assessment of body composition, particularly muscle wasting, in the cardiogenic shock population.

The ultrasound device received 501(k) designation from the FDA in 2009 for measurement of localized fat and muscle thickness. Baseline US muscle thickness assessments will occur at baseline after consent; then days 3 and 7 after baseline study visit; then every 7 days thereafter until end of the index hospitalization (discharge or death). Each measurement session will take about 20-30 minutes.The investigators will take measurements at two sites: the lateral thigh and bicep (participant's dominant side). Clear ultrasound gel will be applied to the skin and the ultrasound probe placed against the skin, and the muscle thickness measurement made five times at each position.

The US images are read after a study visit completion, with measurements taken at pre-specified anatomic landmarks to obtain the muscle thickness, which is averaged accross the duplicate measurements. The primary endpoints are: Percentage change in skeletal muscle thickness from admission to nadir; Percentage change in skeletal muscle thickness after advanced therapies; and the Relationship between muscle mass loss during cardiogenic shock and subsequent clinical outcomes.

Conditions

Heart Failure; Muscle Atrophy; Skeletal Muscle Atrophy; Cardiogenic Shock

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Study Cohort

All enrolled participants with no randomization group allocations

BodyMetrix Body Composition Ultrasound

Intervention Type: DIAGNOSTIC_TEST

We will use a BodyMetrix Pro A-mode ultrasound device (BodyMetrix Pro, Intelametrix Inc., Livermore, CA) which is a lay imaging tool designed specifically to assess body composition. Images will be taken at two sites; the lateral thigh and bicep on the dominant side if able to identify, or else on the right side. On each visit, five images will be taken at each site (the lateral thigh and bicep). Participants will be measured 2-3 days from initiation in study, then 7 days after, and then weekly from the first measurement until time of advanced therapy, discharge, or death. This measurement sequence will then be repeated following advanced therapy up until discharge or death. Each measurement session will last about 20-30 minutes. This will be performed by the PI or members of the study team who have been trained by the research coordinator.

Interventions

BodyMetrix Body Composition Ultrasound

We will use a BodyMetrix Pro A-mode ultrasound device (BodyMetrix Pro, Intelametrix Inc., Livermore, CA) which is a lay imaging tool designed specifically to assess body composition. Images will be taken at two sites; the lateral thigh and bicep on the dominant side if able to identify, or else on the right side. On each visit, five images will be taken at each site (the lateral thigh and bicep). Participants will be measured 2-3 days from initiation in study, then 7 days after, and then weekly from the first measurement until time of advanced therapy, discharge, or death. This measurement sequence will then be repeated following advanced therapy up until discharge or death. Each measurement session will last about 20-30 minutes. This will be performed by the PI or members of the study team who have been trained by the research coordinator.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Over 18 years of age

2. Ejection fraction <40%

3. Cardiogenic shock defined by clinical criteria (including any of: lactate >2.5 mmol/L, systolic blood pressure <90 mmHg, acute kidney or liver injury, or cardiac index <2.1 on hemodynamic monitoring) plus the clinical requirement for at least one pressor, inotrope, or temporary mechanical circulatory support device (MCSD)

Exclusion Criteria

1. History of LVAD or other durable ventricular assist device

2. An identified clinical disorder associated with skeletal muscle weakness/wasting (e.g., muscular dystrophy, mitochondrial disorder, active cancer, modified Rankin score greater or equal to 4 post-stroke

3. Chronic enteric and parenteral nutrition support patients

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tufts Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tufts Medical Center

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Amanda R Vest, MBBS

Role: CONTACT

avest@tuftsmedicalcenter.org

617-636-8068

Facility Contacts

Olivia Lovegreen

Role: primary

OLovegreen@tuftsmedicalcenter.org

617-636-5000

Amanda R Vest, MBBS

Role: backup

Other Identifiers

STUDY00004088

Identifier Type: -

Identifier Source: org_study_id