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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00414401
Other study ID # IIR 01-108
Secondary ID
Status Completed
Phase N/A
First received December 19, 2006
Last updated April 6, 2015
Start date May 2001
Est. completion date June 2006

Study information

Verified date December 2006
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

Although beta-blockers are known to prolong survival for patients with reduced left ventricular ejection fraction, their use in the community and the VA is suboptimal.


Description:

Background:

Although beta-blockers are known to prolong survival for patients with reduced left ventricular ejection fraction, their use in the community and the VA is suboptimal.

Objectives:

To determine if a reminder attached to the echocardiography report would increase the use of beta-blockers among patients with depressed left ventricular function.

Methods:

We are randomizing consecutive patients undergoing echocardiography at one of three VA echocardiography laboratories with reduced left ventricular ejection fraction (<40%) and no echocardiographic contraindication to beta-blockers (e.g. aortic stenosis) to a reminder for use of beta-blockers or to no reminder. The reminder gives starting doses for two commonly used beta-blockers (carvedilol and metoprolol). Patients are excluded from the analysis if they leave the health care system or die within three months of randomization. The primary outcome is a prescription for a beta-blocker between three and nine months following echocardiography

Status:

The project is complete.


Recruitment information / eligibility

Status Completed
Enrollment 1500
Est. completion date June 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

Those undergoing echocardiography at one of the participating laboratories with an ejection fraction < 45%.

Exclusion Criteria:

aortic stenosis, mitral stenosis

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Behavioral:
Clinical Reminder


Locations

Country Name City State
United States VA Palo Alto Health Care System, Palo Alto, CA Palo Alto California

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (2)

Heidenreich PA, Chacko M, Goldstein MK, Atwood JE. ACE inhibitor reminders attached to echocardiography reports of patients with reduced left ventricular ejection fraction. Am J Med. 2005 Sep;118(9):1034-7. — View Citation

Heidenreich PA, Gholami P, Sahay A, Massie B, Goldstein MK. Clinical reminders attached to echocardiography reports of patients with reduced left ventricular ejection fraction increase use of beta-blockers: a randomized trial. Circulation. 2007 Jun 5;115( — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Prescription for any beta-blocker No
Secondary Prescription for carvedilol or metoprolol succinate No
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