Congestive Heart FailureNCT00682175
Metabolic Derangements in Acute Heart Failure Syndrome
An observational study of Congestive Heart Failure, run by The Cleveland Clinic.
Trial summary
To determine the association of both neurohormonal and hemodynamic alterations associated with metabolic abnormalities in acute heart failure syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- Observational
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- May 2008to Mar 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
About this study
To determine the association of both neurohormonal and hemodynamic alterations associated with metabolic abnormalities in acute heart failure syndrome.
- Conditions
- Congestive Heart Failure
- Being tested
- Observational
- Keywords
- Congestive Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Observational |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2008 (estimated)
- Study startMay 2008
- Primary completionMar 2009
- Study completionMar 2009
Why it stopped: Project not initiated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Investigators
- George Sokos, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00682175
- Sponsor's protocol ID
- 08-169
- Status last verified
- Mar 2009
- First submitted
- 20 May 2008
- Last updated
- 26 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Derangements in Acute Heart Failure Syndrome
- ClinicalTrials.gov ID
- NCT00682175
- Acronym / sponsor ID
- 08-169
- Conditions
- Congestive Heart Failure
- Keywords
- Congestive Heart Failure
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Project not initiated
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 22 May 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.
To determine the association of both neurohormonal and hemodynamic alterations associated with metabolic abnormalities in acute heart failure syndrome.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation | – | Other: ObservationalAdult (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| ObservationalPulmonary 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 | Other | Observation |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Project not initiated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2009.
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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.
George Sokos, MD principal investigator
The Cleveland Clinic
Questions about this trial
What is this clinical trial studying?
An observational study of Congestive Heart Failure, run by The Cleveland Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. 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: stopped early, as of the sponsor's last update on 26 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: Project not initiated). Results are not available in the source record.
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.
Where can I read the original study information?
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 26 Mar 2009.