Catheterization Laboratory Study: Acute Responses in Diastolic Heart Failure

February 6, 2019 updated by: University of Wisconsin, Madison

Acute Responses in Diastolic Heart Failure

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.

Study Overview

Status

Completed

Conditions

Heart Failure, Congestive

Intervention / Treatment

Drug: nesiritide

Study Type

Interventional

Enrollment (Actual)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
arterial tonometry Time Frame: following catheterization, then following 10 minutes of nesiritide infusion	following catheterization, then following 10 minutes of nesiritide infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Collaborators

Scios, Inc.

Investigators

Principal Investigator: Nancy K Sweitzer, MD PhD, University of Wisconsin, Madison

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (Actual)

June 20, 2007

Study Completion (Actual)

June 20, 2007

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria