Assessing muscle thickness changes in heart failure patients
Changes in Skeletal Muscle Thickness in Patients With Acute Heart Failure
Tufts Medical Center · NCT06253104
This study is testing how muscle thickness changes in heart failure patients receiving advanced treatments like heart transplants or assist devices to see how it affects their recovery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Tufts Medical Center (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06253104 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the changes in skeletal muscle mass in patients with acute heart failure undergoing advanced therapies like orthotropic heart transplantation and left ventricular assist device implantation. Using a non-invasive ultrasound method, the study will measure muscle thickness at specific anatomical sites during hospitalization to understand the relationship between muscle mass loss and patient outcomes. The study will also validate the use of a specific ultrasound device for assessing body composition in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years with an ejection fraction of less than 40% experiencing cardiogenic shock.
Not a fit: Patients with a history of durable ventricular assist devices or conditions associated with skeletal muscle wasting may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management of muscle atrophy in heart failure patients, potentially enhancing their recovery and quality of life.
How similar studies have performed: While there is limited literature on muscle mass changes in heart failure patients using ultrasound, this approach is novel and has not been extensively tested in this specific context.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Boston, Massachusetts
- Tufts Medical Center — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Study coordinator: Amanda R Vest, MBBS
- Email: avest@tuftsmedicalcenter.org
- Phone: 617-636-8068
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Failure, Muscle Atrophy, Skeletal Muscle Atrophy, Cardiogenic Shock