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Changes in Skeletal Muscle Thickness in Patients With Acute Heart Failure

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 100 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Ultrasound

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study uses ultrasound, which takes pictures with sound waves, to track muscle loss in adults with cardiogenic shock, when the heart cannot pump enough blood. It looks at muscle changes and health outcomes after a heart transplant or surgery to place a heart pump. It also checks whether bedside ultrasound can measure muscle changes during a hospital stay.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are older than 18.
  • Your heart pumps out less than 40% of the blood in its main pumping chamber with each beat.
  • You have cardiogenic shock, with at least one of these signs: blood lactate above 2.5 mmol/L, top blood pressure number below 90, sudden kidney or liver injury, or a cardiac index below 2.1—a measure of how much blood your heart pumps.
  • You need at least one medicine to raise blood pressure or help your heart pump, or a temporary device to help move blood.

Who can't join

  • You have had an LVAD or another long-term device that helps your heart pump blood.
  • You have a known condition linked to muscle weakness or loss, such as muscular dystrophy, a disorder affecting how cells make energy, active cancer, or major disability after a stroke (modified Rankin score of 4 or higher).
  • You receive long-term nutrition through a feeding tube or a vein.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 Intubation or prior history of heart transplantation are not exclusion criteria if the inclusion criteria are otherwise met.

Study sites (1)

MA