Electronic Medical Record Alerts to Optimize Medical Ther... | NCT06166823

Studies
Electronic Medical Record Alerts to Optimize Medical Therapy in Heart Failure and Reduced Ejection Fraction

NCT06166823

Sponsor

Instituto Cardiovascular de Buenos Aires

Status

Unknown status

Last Update Posted

Dec 12, 2023Actual

Enrollment

240Estimated

Phase

Not Applicable

Conditions

HFrEF - Heart Failure With Reduced Ejection Fraction

Interventions

EMR alert

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 15, 2024Estimated

Primary Completion Date

Dec 15, 2024Estimated

Completion Date

Jan 1, 2025Estimated

First Submitted Date

Dec 4, 2023

First Submission Date that Met QC Criteria

Dec 4, 2023

First Posted Date

Dec 12, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2023

Last Update Posted Date

Dec 12, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lucrecia Maria Burgos, MD, Instituto Cardiovascular de Buenos AiresPrincipal Investigator

Lead Sponsor

Instituto Cardiovascular de Buenos AiresOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

OPTIMAL-HF is a pragmatic, cluster randomized, single-blind intervention trial that will be conducted at an outpatient clinic in Argentina. The trial will assess the effectiveness of an individualized-based alert system compared to usual care in improving GDMT optimization at 90 days in patients with HFrEF.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

240Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EMR Alert	Experimental		Other: EMR alert
Usual Care	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EMR alert	Other	EMR alert for medication optimization	EMR Alert

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary efficacy endpoint will be the GDMT optimize score in HfrEF patients 90 days after randomization.		90 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Patients

Inclusion Criteria:

Eligible patients will include those with an EF ≤ 40% on their most recent echocardiogram, age > 18, and an outpatient cardiology encounter during the study period.
Age 18 or over

Exclusion Criteria:

under optimal medical treatment
palliative care, or undergoing hemodialysis will be excluded

Cardiologist

Inclusion criteria:

Cardiologists from an outpatient clinic at a cardiovascular center in Buenos Aires will be selected for potential participation in the study.

Exclusion criteria Cardiologists belonging to the heart failure service

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Lucrecia Burgos, MD	Contact	47508700		lburgos@icba.com.ar

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided