Catheterization Laboratory Study: Acute Responses in Diastolic Heart Failure - Full Text View

Sponsors and Collaborators:	University of Wisconsin, Madison Scios, Inc.
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00204945

Purpose

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.

Condition	Intervention
Heart Failure, Congestive	Drug: nesiritide

MedlinePlus related topics: Heart Failure

Drug Information available for: Nesiritide

Study Type:	Interventional
Study Design:	Health Services Research, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Acute Responses in Diastolic Heart Failure

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:

arterial tonometry [ Time Frame: following catheterization, then following 10 minutes of nesiritide infusion ] [ Designated as safety issue: No ]

Estimated Enrollment:	65
Study Start Date:	February 2005
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00204945

Locations

United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

University of Wisconsin, Madison

Scios, Inc.

Investigators

Principal Investigator:

Nancy K Sweitzer, MD PhD

University of Wisconsin, Madison

More Information

Responsible Party:	University of Wisconsin ( Nancy K. Sweitzer, MD, PhD )
Study ID Numbers:	2001-496, K23 AGO01022
Study First Received:	September 13, 2005
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00204945
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Wisconsin, Madison:

arterial stiffness
echocardiography
nesiritide
high heart pressures
cardiac catheterization

Study placed in the following topic categories:

Natriuretic Peptide, Brain
Heart Failure, Diastolic
Heart Failure
Heart Diseases

Additional relevant MeSH terms:

Natriuretic Agents
Therapeutic Uses
Physiological Effects of Drugs

Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009