NCT01734135

Brief Summary

This proposal examines use of a clinical reminder to the primary provider of patient with a high B type natriuretic peptide but no prior imaging. Electrical Medical Record-based Intervention to Determine whether Clinical Reminders Improve Heart Failure Management in Patients with High BNP Values and Unknown LVEF.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Oct 2010

Longer than P75 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 27, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

September 19, 2025

Status Verified

April 1, 2016

Enrollment Period

2.9 years

First QC Date

November 20, 2012

Last Update Submit

September 15, 2025

Conditions

Keywords

B type natriuretic peptideheart failurecardiac imagingquality of care

Outcome Measures

Primary Outcomes (1)

  • Measurement of left ventricular ejection fraction

    numerator: Measurement of left ventricular ejection fraction within 6 months of randomization. denominator: All randomized patients

    6 months after randomization

Secondary Outcomes (2)

  • Identification of LVEF < 40%

    6 months following randomizaiton

  • Treatment of Low LVEF

    6 months following randomization

Study Arms (2)

Usual Care

NO INTERVENTION

Usual care

Clinical Reminder

EXPERIMENTAL

A note is sent to the primary care provider using the electronic medical record indicating the high BNP result and potential benefit of measurement of the left ventricular ejection fraction. A draft order is placed for an echocardiogram for the provider to accept or delete.

Other: Clinical Reminder

Interventions

A note is sent to the primary care provider using the electronic medical record indicating the high BNP result and potential benefit of measurement of the left ventricular ejection fraction. A draft order is placed for an echocardiogram for the provider to accept or delete.

Clinical Reminder

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BNP \>= 200 pg/ml in last 2 months

You may not qualify if:

  • Measure of LVEF in the last 12 months
  • Last measure of LVEF \< 40%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Paul A Heidenreich, MD, MS

    VA Palo Alto HCS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

November 20, 2012

First Posted

November 27, 2012

Study Start

October 1, 2010

Primary Completion

September 1, 2013

Study Completion

September 1, 2015

Last Updated

September 19, 2025

Record last verified: 2016-04

Locations