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Metabolic Derangements in Acute Heart Failure Syndrome

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ClinicalTrials.gov Identifier: NCT00682175
Recruitment Status : Terminated (Project not initiated)
First Posted : May 22, 2008
Last Update Posted : March 26, 2009
Sponsor:
Information provided by:
The Cleveland Clinic

Study Description
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Brief Summary:
To determine the association of both neurohormonal and hemodynamic alterations associated with metabolic abnormalities in acute heart failure syndrome.

Condition or disease Intervention/treatment
Congestive Heart Failure Other: Observational

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Metabolic Derangements in Acute Heart Failure Syndrome
Study Start Date : May 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

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U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Observation
Adult (age > 18 yrs) patients admitted to the Heart Failure Intensive Care Unit with Acute Heart Failure Syndrome requiring placement of a Pulmonary Artery catheter for hemodynamically guided therapy.
 Other: Observational
Pulmonary Artery pressure (PA), pulmonary capillary wedge pressure (PCWP), cardiac output (CO), and cardiac index (CI). This data will be collected after 24 ± 2 and 48 ± 2 hours of standard heart failure therapy


Outcome Measures
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Biospecimen Retention:   Samples Without DNA
serum, plasma

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult (age > 18 yrs) patients admitted to the Heart Failure Intensive Care Unit (H22) with Acute Heart Failure Syndrome (AHFS) requiring placement of a Pulmonary Artery catheter for hemodynamically guided therapy.
Criteria

Inclusion Criteria:

  • Adult (age > 18 yrs) patients admitted to the Heart Failure Intensive Care Unit (H22) with Acute Heart Failure Syndrome (AHFS) requiring placement of a Pulmonary Artery catheter for hemodynamically guided therapy.

Exclusion Criteria:

  • History of Congenital Heart Disease.
  • Acute HF in the setting of acute myocardial infarction.
  • Severe Anemia
  • Patients listed for cardiac transplantation.
  • Terminal Malignancy, AIDS or CNS disease.
  • Concomitant sepsis, ARDS, trauma, aortic dissection, or pericardial tamponade
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00682175


Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: George Sokos, MD The Cleveland Clinic
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: George Sokos, MD, Cleveland Clinic Foundation
ClinicalTrials.gov Identifier: NCT00682175     History of Changes
Other Study ID Numbers: 08-169
First Posted: May 22, 2008    Key Record Dates
Last Update Posted: March 26, 2009
Last Verified: March 2009

Keywords provided by The Cleveland Clinic:
Congestive Heart Failure

Additional relevant MeSH terms:
Heart Failure
Metabolic Diseases
Heart Diseases
Cardiovascular Diseases