NCT06166823

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2024

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 12, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

January 15, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

December 12, 2023

Status Verified

December 1, 2023

Enrollment Period

11 months

First QC Date

December 4, 2023

Last Update Submit

December 4, 2023

Conditions

HFrEF - Heart Failure With Reduced Ejection Fraction

Outcome Measures

Primary Outcomes (1)

  • The primary efficacy endpoint will be the GDMT optimize score in HfrEF patients 90 days after randomization.

    90 days

Study Arms (2)

EMR Alert

EXPERIMENTAL
Other: EMR alert

Usual Care

NO INTERVENTION

Interventions

EMR alertOTHER

EMR alert for medication optimization

EMR Alert

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • under optimal medical treatment
  • palliative care, or undergoing hemodialysis will be excluded
  • Cardiologist
  • Cardiologists from an outpatient clinic at a cardiovascular center in Buenos Aires will be selected for potential participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Lucrecia Burgos, MD

CONTACT

47508700lburgos@icba.com.ar

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 4, 2023

First Posted

December 12, 2023

Study Start

January 15, 2024

Primary Completion

December 15, 2024

Study Completion

January 1, 2025

Last Updated

December 12, 2023

Record last verified: 2023-12