Congestive Heart FailureNCT00595738
Peripheral Venous Oxygen Saturation and Biomarkers to Estimate Cardiac Output and Filling Pressures in Heart Failure
An observational study of Congestive Heart Failure, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Congestive Heart Failure
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Jan 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
The following inclusion criteria will be utilized:
- Age>21
- 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
- Known or suspected septic shock or bacteremia
- Active bleeding or HCT<24% at baseline
- Arterial oxygen saturation <90% at baseline despite supplemental oxygen therapy.
- Previous difficulty with venipuncture of upper extremity veins or the presence of a surgical arteriovenous fistula for hemodialysis
- Insertion of the PA catheter through the femoral vein
- Subjects unwilling or unable to provide written consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital, Coronary Care Unit
Boston, Massachusetts, 02114
About this study
Official title: Use of Peripheral Venous Oxygen Saturation and Biomarkers to Estimate Cardiac Output and Filling Pressures in Patients With Advanced Heart Failure
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.
- Conditions
- Congestive Heart Failure
- Being tested
- Standard of care therapy for severe decompensated heart failure
- Keywords
- Congestive heart failure, Cardiac biomarkers, Hemodynamics, Tailored therapy
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of care therapy for severe decompensated heart failureOther
Standard of care therapy for severe decompensated heart failure
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Standard of care therapy for severe decompensated heart failure |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the relationship between mixed venous, central venous, and peripheral venous oxygen saturation in patients with advanced (class III or IV) heart failure.
Measured: Day 0-5 of 'tailored' heart failure therapy
Secondary outcomes (1)
To examine the relationship of selected cardiac biomarkers with cardiac filling pressures and cardiac output over time in patients with decompensated heart failure.
Measured: Days 0-5 of 'tailored' heart failure therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startDec 2007
- Primary completionAug 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Siemens Molecular Imaging, Critical Diagnostics
- Investigators
- Thomas J Wang, MD, Principal investigator, Massachusetts General HospitalJames Januzzi, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00595738
- Sponsor's protocol ID
- 2007P-000704
- Status last verified
- Jul 2011
- First submitted
- 7 Jan 2008
- Last updated
- 20 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Zilinski JL, Shah RV, Gaggin HK, Gantzer ML, Wang TJ, Januzzi JL. Measurement of multiple biomarkers in advanced stage heart failure patients treated with pulmonary artery catheter guided therapy. Crit Care. 2012 Jul 25;16(4):R135. doi: 10.1186/cc11440.
PubMed 22830581
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Peripheral Venous Oxygen Saturation and Biomarkers to Estimate Cardiac Output and Filling Pressures in Patients With Advanced Heart Failure
- ClinicalTrials.gov ID
- NCT00595738
- Acronym / sponsor ID
- 2007P-000704
- Conditions
- Congestive Heart Failure
- Keywords
- Congestive heart failure, Cardiac biomarkers, Hemodynamics, Tailored therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Siemens Molecular Imaging, Critical Diagnostics
- Study start
- Dec 2007
- Primary completion
- Aug 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 16 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart Failure Patients | – | Other: Standard of care therapy for severe decompensated heart failurePatients 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of care therapy for severe decompensated heart failureStandard of care therapy for severe decompensated heart failure | Other | Heart Failure Patients |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2011.
- Derived from this study: PubMed 22830581Zilinski JL, Shah RV, Gaggin HK, Gantzer ML, Wang TJ, Januzzi JL. Measurement of multiple biomarkers in advanced stage heart failure patients treated with pulmonary artery catheter guided therapy. Crit Care. 2012 Jul 25;16(4):R135. doi: 10.1186/cc11440.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas J Wang, MD principal investigator
Massachusetts General Hospital
James Januzzi, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congestive Heart Failure, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00595738, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2011.