Catheterization Laboratory Study: Acute Responses in Diastolic Heart Failure

University of Wisconsin (UW)

Status: Completed

Conditions: Heart Failure, Congestive

Treatments: Drug: nesiritide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00204945

K23 AGO01022

2001-496

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)