Electronic Medical Record Alerts to Optimize Medical Therapy in Heart Failure and Reduced Ejection Fraction (OPTIMAL-HF)

December 4, 2023 updated by: Lucrecia Maria Burgos, Instituto Cardiovascular de Buenos Aires

Electronic Medical Record Alerts to Optimize Medical Therapy in Heart Failure and Reduced Ejection Fraction in a Low-middle Income Country

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care
Experimental: EMR Alert
Other: EMR alert
EMR alert for medication optimization

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Cardiovascular de Buenos Aires

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 15, 2024

Primary Completion (Estimated)

December 15, 2024

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

December 4, 2023

First Submitted That Met QC Criteria

December 4, 2023

First Posted (Actual)

December 12, 2023

Study Record Updates

Last Update Posted (Actual)

December 12, 2023

Last Update Submitted That Met QC Criteria

December 4, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01 (Miami VAHS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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