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

This study has been completed.
Sponsor:
Collaborators:
Siemens Molecular Imaging
Critical Diagnostics
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00595738
First received: January 7, 2008
Last updated: July 19, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention
Congestive Heart Failure
Other: Standard of care therapy for severe decompensated heart failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Use of Peripheral Venous Oxygen Saturation and Biomarkers to Estimate Cardiac Output and Filling Pressures in Patients With Advanced Heart Failure

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

We will be banking serum collected from peripheral blood draws, and blood draws from a pulmonary artery catheter and arterial line.


Estimated Enrollment: 30
Study Start Date: December 2007
Study Completion Date: January 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Other: Standard of care therapy for severe decompensated heart failure
Standard of care therapy for severe decompensated heart failure

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study population will consist of 30 patients admitted to the Massachusetts General Hospital Coronary Care Unit (CCU) for PA catheter-directed therapy for advanced heart failure. Only patients for whom the attending cardiologist has already decided upon PA-catheter insertion will be recruited for the study.

Potential subjects will be identified by the CCU attending cardiologist, and a study nurse will review each patient for the exclusion criteria as above. Final decisions on patient eligibility will be made by Dr. Wang.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00595738

Locations
United States, Massachusetts
Massachusetts General Hospital, Coronary Care Unit
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Siemens Molecular Imaging
Critical Diagnostics
Investigators
Principal Investigator: Thomas J Wang, MD Massachusetts General Hospital
Principal Investigator: James Januzzi, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Thomas J. Wang, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00595738     History of Changes
Other Study ID Numbers: 2007P-000704
Study First Received: January 7, 2008
Last Updated: July 19, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Congestive heart failure
Cardiac biomarkers
Hemodynamics
Tailored therapy

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 20, 2014