Catheterization Laboratory Study: Acute Responses in Diastolic Heart Failure

Heart Failure, Congestive Clinical Trial

Official title:

Acute Responses in Diastolic Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00204945
• Other study ID #: 2001-496
• Secondary ID: K23 AGO01022
• Status: Completed
• Phase: N/A
• Start date: February 2005
• Est. completion date: June 20, 2007

Study information

• Verified date: February 2019
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 20, 2007
• Est. primary completion date: June 20, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Congestive
• Heart Failure, Diastolic

Intervention

Drug:
• nesiritide
a bolus, then infusion of nesiritide for 10-15 minutes

Locations

Country	Name	City	State
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Scios, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	arterial tonometry		following catheterization, then following 10 minutes of nesiritide infusion