Catheterization Laboratory Study: Acute Responses in Diastolic Heart Failure
Primary Purpose
Heart Failure, Congestive
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
nesiritide
Sponsored by
About this trial
This is an interventional health services research trial for Heart Failure, Congestive focused on measuring arterial stiffness, echocardiography, nesiritide, high heart pressures, cardiac catheterization
Eligibility Criteria
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.
Sites / Locations
- University of Wisconsin Hospital and Clinics
Outcomes
Primary Outcome Measures
arterial tonometry
Secondary Outcome Measures
Full Information
NCT ID
NCT00204945
First Posted
September 13, 2005
Last Updated
February 6, 2019
Sponsor
University of Wisconsin, Madison
Collaborators
Scios, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00204945
Brief Title
Catheterization Laboratory Study: Acute Responses in Diastolic Heart Failure
Official Title
Acute Responses in Diastolic Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
June 20, 2007 (Actual)
Study Completion Date
June 20, 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
Scios, Inc.
4. Oversight
5. Study Description
Brief Summary
Research question: What is the response of the heart's pumping function to changes in heart chamber pressures?
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive
Keywords
arterial stiffness, echocardiography, nesiritide, high heart pressures, cardiac catheterization
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
nesiritide
Intervention Description
a bolus, then infusion of nesiritide for 10-15 minutes
Primary Outcome Measure Information:
Title
arterial tonometry
Time Frame
following catheterization, then following 10 minutes of nesiritide infusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy K Sweitzer, MD PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin Hospital and Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
12. IPD Sharing Statement
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Catheterization Laboratory Study: Acute Responses in Diastolic Heart Failure
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