Catheterization Laboratory Study: Acute Responses in Diastolic Heart Failure

NCT00204945 | Completed

• 2 other identifiers: 2001-496K23 AGO01022
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Research question: What is the response of the heart's pumping function to changes in heart chamber pressures?
2. 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.

Conditions

Heart Failure, Congestive

Keywords

arterial stiffness; echocardiography; nesiritide; high heart pressures; cardiac catheterization

Outcome Measures

Primary Outcomes (1)

• arterial tonometry

  following catheterization, then following 10 minutes of nesiritide infusion

Interventions

nesiritide DRUG

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cardiac catheterization

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Scios, Inc.: collaborator

Study Sites (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Natriuretic Peptide, Brain

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Natriuretic Peptides; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Nancy K Sweitzer, MD PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: February 1, 2005
• Primary Completion: June 20, 2007
• Study Completion: June 20, 2007
• Last Updated: February 8, 2019

Record last verified: 2019-02

Locations

US (1)