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Metabolomics Study


Title Epidermal Metabolomic Changes in Patients with Cardiogenic Shock
Therapeutic Area Heart Failure, Cardiac Failure
Principal Investigator Amanda Vest, MD
Min Age 18 Years
Gender All
Contact Amanda Vest, MD
617-636-6049
avest@tuftsmedicalcenter.org

Overview

The purpose of this study is to determine the relationship between levels of metabolites, such as lactate in the sweat of the skinm, and the severity of heart failure.  We hope to determine whether the levels of lactate and other metabolites on the skin change as heart failure severity improves during a hospitalization.  This information oculd also be used to develop ways to detect worsening heart failure severity using a sweat-based test.  The study seeks to recruit patients admitted to Tufts Medical Center due to decompensated heart failure.   There are 2 study visits which each require the collection of 15ml of fasted venous blood, a completed KCCQ, and holding a damped gauze between the palms for 2 minutes.   The baseline study visit takes place within 72 hour of admission and the second study visit takes place within 3 and 60 days of the baseline visit when the patient meets criteria for clinical stability.

Study Details

Inclusion Criteria

  • Admitted to Tufts Medical Center with severely decompensated HF (any left ventricular ejection fraction) as evidenced by a requirement for intravenous inotropes or temporary mechanical support to restore end-organ function; or any of systolic blood pressure <100 mmHg, serum lactate level >2 mmol/L, cardiac index <2.1 L/min/m2, bilirubin or creatinine elevated >30% above prior baseline.
  • Approached within 72 hours of Tufts Medical Center admission
  • Able and willing to sign study consent

Exclusion Criteria

  • Durable left ventricular assist device (LVAD) in place or prior heart transplantation
  • Intubated for the first 72 hours of Tufts MC admission (therefore unable to give consent, complete KCCQ)
  • Currently pregnant

Study Requirements

  • There are  2 research visits; Study visit 1 occurs  within 72 hours of admission of Tufts MC for severely decompensated HF.   Study visit 2 occurs when the patients meets the criteria for clinical stability within the window of 3 to 60 days of baseline study visit.
  • Participation in this study will last between 3 and 60 days.
  • Blood collections: There will be a total o 2 blood collections, one blood collection per study visit.   At each blood collection, 15ml of fasted venous blood will be collected from the subject.
  • At each study visit, subject holds damped gauze between palms or 2 minutes and completes the Kansas City Cardiomyopathy Questionnaire (KCCQ).
  • No x-rays/CT scans/MRIs will be conducted.