Catheterization Laboratory Study: Acute Responses in Diastolic Heart Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2007-06-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Heart Failure, Congestive

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Interventions

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nesiritide

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No