Catheterization Laboratory Study: Acute Responses in Diastolic Heart Failure

Acute Responses in Diastolic Heart Failure

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00204945

Enrollment

Registered

2005-09-20

Start date

2005-02-28

Completion date

2007-06-20

Last updated

2019-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Congestive

Keywords

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

Brief summary

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.

Interventions

DRUGnesiritide

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
arterial tonometry	following catheterization, then following 10 minutes of nesiritide infusion

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026