Other Clinical Trial - Electronic Medical Record Alerts to Optimize

Clinical Trial 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.

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT06166823
Study type	Interventional
Source	Instituto Cardiovascular de Buenos Aires
Contact	Lucrecia Burgos, MD
Phone	47508700
Email	lburgos@icba.com.ar
Status	Not yet recruiting
Phase	N/A
Start date	January 15, 2024
Completion date	January 1, 2025

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms