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Catheterization Laboratory Study: Acute Responses in Diastolic Heart Failure

This study has been completed.
Sponsor:
Collaborator:
Scios, Inc.
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00204945
First received: September 13, 2005
Last updated: January 15, 2009
Last verified: January 2009
History of Changes
  Purpose
  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.

Condition Intervention
Heart Failure, Congestive
 Drug: nesiritide

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Acute Responses in Diastolic Heart Failure

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
Drug Information available for: Nesiritide
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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

No publications provided

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

Keywords provided by University of Wisconsin, Madison:
arterial stiffness
echocardiography
nesiritide
high heart pressures
cardiac catheterization

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases
Natriuretic Peptide, Brain
 Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013