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NCT06253104 · ClinicalTrials.gov registry record
Changes in Skeletal Muscle Thickness in Patients With Acute Heart Failure
A clinical trial of Heart Failure and Cardiogenic Shock, sponsored by Tufts Medical Center.
- Recruiting
- Registry status
- 60
- Enrollment target
- 1
- Study location
NCT06253104: Recruiting study of Heart Failure and Cardiogenic Shock, sponsored by Tufts Medical Center.
NCT06253104 is a study of Heart Failure and Cardiogenic Shock that is actively recruiting participants, run by Tufts Medical Center. The registered enrollment target is 60 participants, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06253104, a study of Heart Failure and Cardiogenic Shock, is actively recruiting participants, sponsored by Tufts Medical Center.
- RECRUITING
- Registry status
- 60 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Quantify the percentage change in skeletal muscle thickness from admission to nadir of muscle thickness and describe the time course of muscle loss. We hypothesize that all patients will experience a decrease in skeletal muscle thickness in the days-to-weeks after admission, as indicated by change in skeletal muscle thickness on ultrasound, and anticipate the magnitude of this muscle thickness change to be in the range of -5%. This aim will be investigated in both patients who ultimately receive
Conditions Studied
Interventions
- DIAGNOSTIC_TEST BodyMetrix Body Composition Ultrasound
Study Locations (1)
Massachusetts
- Tufts Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2024-02-19 |
| Est. Completion | 2026-12-31 |
What NCT06253104 shows while recruiting
NCT06253104 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (97% lower).
The record links to 4 conditions, with Heart Failure appearing as the primary indexed condition, and to 1 intervention - of which BodyMetrix Body Composition Ultrasound is the first listed.
NCT06253104 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06253104 about?
NCT06253104 is a clinical study titled "Changes in Skeletal Muscle Thickness in Patients With Acute Heart Failure". 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...
What is the current status of trial NCT06253104?
This trial is currently recruiting. The enrollment target is 60 participants. The study started on 2024-02-19. Estimated completion is 2026-12-31.
What conditions does trial NCT06253104 study?
This clinical trial studies the following conditions: Heart Failure, Cardiogenic Shock, Muscle Atrophy, Skeletal Muscle Atrophy.
What interventions are being tested in trial NCT06253104?
The interventions under investigation include: BodyMetrix Body Composition Ultrasound (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT06253104?
This trial is sponsored by Tufts Medical Center, which has 169 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06253104 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Heart Failure
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06253104's enrollment target sits among peer trials
60 254th of 397 higher than 131 of 397 other Heart Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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