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Catheterization Laboratory Study: Acute Responses in Diastolic Heart Failure

This study has been completed.
Sponsor:
Collaborator:
Scios, Inc.
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00204945
First received: September 13, 2005
Last updated: January 15, 2009
Last verified: January 2009
History of Changes

September 13, 2005
January 15, 2009
February 2005
March 2008   (final data collection date for primary outcome measure)
arterial tonometry [ Time Frame: following catheterization, then following 10 minutes of nesiritide infusion ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00204945 on ClinicalTrials.gov Archive Site
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Catheterization Laboratory Study: Acute Responses in Diastolic Heart Failure
Acute Responses in Diastolic Heart Failure
  1. Research question: What is the response of the heart's pumping function to changes in heart chamber pressures?
  2. Experimental design: Patients undergoing routine cardiac catheterization will be studied. A thermodilution pulmonary artery catheter will be inserted through a venous sheath and threaded into the pulmonary artery. After several minutes of quiet rest, baseline hemodynamics will be obtained, including a determination of cardiac output using thermodilution techniques and 30 seconds of pressure recordings from the left ventricle and proximal aorta. In addition, a brief echocardiogram will be performed, to determine ejection fraction and indices of diastolic filling. Finally, arterial tonometry will be obtained in quick succession from the brachial, radial, femoral, and carotid arteries. Following the collection of baseline data, a bolus and infusion of nesiritide will be started. After 10 minutes of nesiritide infusion, with the drug still infusing, a full set of invasive hemodynamics will again be obtained, as well as brief echocardiographic and arterial tonometry examinations.
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Interventional
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Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Heart Failure, Congestive
Drug: nesiritide
a bolus, then infusion of nesiritide for 10-15 minutes
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
March 2008
March 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Cardiac catheterization

Exclusion Criteria:

  • Unstable coronary syndrome,
  • Critical coronary stenoses (>90%),
  • Severe peripheral vascular disease,
  • Symptomatic hypotension at completion of routine diagnostic cath,
  • Significant valvular disease, resting heart rate >120 beats/min,
  • Ejection fraction <45%,
  • Presence of contraindications to nesiritide administration,
  • Any evidence of clinical instability.
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00204945
2001-496, K23 AGO01022
Not Provided
Nancy K. Sweitzer, MD, PhD, University of Wisconsin
University of Wisconsin, Madison
Scios, Inc.
Principal Investigator: Nancy K Sweitzer, MD PhD University of Wisconsin, Madison
University of Wisconsin, Madison
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP