RECRUITING

Changes in Skeletal Muscle Thickness in Patients With Acute Heart Failure

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Changes in Skeletal Muscle Thickness in Patients With Acute Heart Failure

Quick Facts

Study Start:2024-02-19
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06253104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Over 18 years of age
  2. 2. Ejection fraction \<40%
  3. 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)
  1. 1. History of LVAD or other durable ventricular assist device
  2. 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. 3. Chronic enteric and parenteral nutrition support patients

Contacts and Locations

Study Contact

Amanda R Vest, MBBS
CONTACT
617-636-8068
avest@tuftsmedicalcenter.org

Study Locations (Sites)

Tufts Medical Center
Boston, Massachusetts, 02111
United States

Collaborators and Investigators

Sponsor: Tufts Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-19
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2024-02-19
Study Completion Date2024-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Heart Failure
  • Muscle Atrophy
  • Skeletal Muscle Atrophy
  • Cardiogenic Shock