Metabolic Derangements in Acute Heart Failure Syndrome
This study has been terminated.
(Project not initiated)
Sponsor:
The Cleveland Clinic
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00682175
First received: May 20, 2008
Last updated: March 25, 2009
Last verified: March 2009
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | May 20, 2008 | ||||
| Last Updated Date | March 25, 2009 | ||||
| Start Date ICMJE | May 2008 | ||||
| Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00682175 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Metabolic Derangements in Acute Heart Failure Syndrome | ||||
| Official Title ICMJE | Metabolic Derangements in Acute Heart Failure Syndrome | ||||
| Brief Summary | To determine the association of both neurohormonal and hemodynamic alterations associated with metabolic abnormalities in acute heart failure syndrome. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: serum, plasma |
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| 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. |
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| Condition ICMJE | Congestive Heart Failure | ||||
| Intervention ICMJE | 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 |
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| Study Group/Cohort (s) | 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.
Intervention: Other: Observational |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Completion Date | March 2009 | ||||
| Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00682175 | ||||
| Other Study ID Numbers ICMJE | 08-169 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | George Sokos, MD, Cleveland Clinic Foundation | ||||
| Study Sponsor ICMJE | The Cleveland Clinic | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | The Cleveland Clinic | ||||
| Verification Date | March 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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