NCT00682175

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2008

Shorter than P25 for all trials

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

March 26, 2009

Status Verified

March 1, 2009

Enrollment Period

10 months

First QC Date

May 20, 2008

Last Update Submit

March 25, 2009

Conditions

Congestive Heart Failure

Keywords

Congestive Heart Failure

Study Arms (1)

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

Interventions

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

Observation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum, plasma

MeSH Terms

Conditions

Heart Failure

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • George Sokos, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 20, 2008

First Posted

May 22, 2008

Study Start

May 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

March 26, 2009

Record last verified: 2009-03