Peripheral Venous Oxygen Saturation and Biomarkers to Estimate Cardiac Output and Filling Pressures in Heart Failure

Overview

The relationship between peripheral venous saturation and central hemodynamics (including right and left heart filling pressures and cardiac output), mixed venous oxygen saturation, and contemporary biomarkers of heart failure is not clear. We aim to determine the relationship between mixed venous, central venous, and peripheral venous oxygen saturation in patients with advanced (class III or IV) heart failure. We will determine the relationship between cardiac output measured via thermodilution and the Fick equation calculated using concurrent oxygen saturations from the distal PA, central vein, and peripheral vein. We also aim to examine the relationship of selected cardiac biomarkers with cardiac filling pressures and cardiac output over time in patients with decompensated heart failure.

Full Title of Study: “Use of Peripheral Venous Oxygen Saturation and Biomarkers to Estimate Cardiac Output and Filling Pressures in Patients With Advanced Heart Failure”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 2010

Interventions

  • Other: Standard of care therapy for severe decompensated heart failure
    • Standard of care therapy for severe decompensated heart failure

Arms, Groups and Cohorts

  • Heart Failure Patients
    • Patients admitted with advanced heart failure for tailoring of heart failure therapy via placement of a pulmonary artery (PA) catheter. In our study, the patients will already have a PA catheter placed for clinical/treatment reasons when we approach them for the study.

Clinical Trial Outcome Measures

Primary Measures

  • To determine the relationship between mixed venous, central venous, and peripheral venous oxygen saturation in patients with advanced (class III or IV) heart failure.
    • Time Frame: Day 0-5 of ‘tailored’ heart failure therapy

Secondary Measures

  • To examine the relationship of selected cardiac biomarkers with cardiac filling pressures and cardiac output over time in patients with decompensated heart failure.
    • Time Frame: Days 0-5 of ‘tailored’ heart failure therapy

Participating in This Clinical Trial

The following inclusion criteria will be utilized: 1. Age>21 2. PA-catheter insertion for therapy of congestive heart failure decided upon by the attending cardiologist The following will be considered as exclusion criteria for this study 1. Known or suspected septic shock or bacteremia 2. Active bleeding or HCT<24% at baseline 3. Arterial oxygen saturation <90% at baseline despite supplemental oxygen therapy. 4. Previous difficulty with venipuncture of upper extremity veins or the presence of a surgical arteriovenous fistula for hemodialysis 5. Insertion of the PA catheter through the femoral vein 6. Subjects unwilling or unable to provide written consent

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Massachusetts General Hospital
  • Collaborator
    • Siemens Molecular Imaging
  • Provider of Information About this Clinical Study
    • Thomas J. Wang, MD, Massachusetts General Hospital
  • Overall Official(s)
    • Thomas J Wang, MD, Principal Investigator, Massachusetts General Hospital
    • James Januzzi, MD, Principal Investigator, Massachusetts General Hospital

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