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Study Cohort for Heart Failure

N/A
Recruiting
Research Sponsored by Tufts Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up images obtained 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)
Awards & highlights

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.

Eligible Conditions
  • Heart Failure
  • Cardiogenic Shock
  • Muscle Wasting
  • Muscle Atrophy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~images obtained 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)
This trial's timeline: 3 weeks for screening, Varies for treatment, and images obtained 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) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage change in skeletal muscle thickness after advanced therapies
Percentage change in skeletal muscle thickness from admission to nadir of muscle thickness
Relationship between muscle mass loss during cardiogenic shock and subsequent clinical outcomes
Secondary outcome measures
Discharge to a rehabilitation facility versus home
Geriatric nutritional risk index (GNRI)
Inhospital mortality
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Study CohortExperimental Treatment1 Intervention
All enrolled participants with no randomization group allocations

Find a Location

Who is running the clinical trial?

Tufts Medical CenterLead Sponsor
252 Previous Clinical Trials
252,938 Total Patients Enrolled
10 Trials studying Heart Failure
2,676 Patients Enrolled for Heart Failure

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Changes in Skeletal Muscle Thickness in Patients With Acute Heart Failure
2024. "Changes in Skeletal Muscle Thickness in Patients With Acute Heart Failure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06253104.
All > Paid Studies Boston
~40 spots leftby Dec 2024
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