NCT06253104 Changes in Skeletal Muscle Thickness in Patients With Acute Heart Failure
| NCT ID | NCT06253104 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tufts Medical Center |
| Condition | Heart Failure |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-02-19 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2024-02-19 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06253104 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06253104 currently recruiting?
Yes, NCT06253104 is actively recruiting participants. Contact the research team at avest@tuftsmedicalcenter.org for enrollment information.
Where is the NCT06253104 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT06253104 clinical trial?
NCT06253104 is sponsored by Tufts Medical Center. The trial plans to enroll 60 participants.
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