← Back to Search

Best Practice Alerts for Heart Failure (PROMPT-MRA Trial)

N/A

Waitlist Available

Led By Francis P Wilson, MD MSCE

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Not currently prescribed an MRA

Be older than 18 years old

Must not have

Absolute contraindication to MRAs

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured at 6 months post randomization

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if a best practice alert system can increase the prescription of mineralocorticoid receptor antagonists (MRAs) for eligible heart failure patients with reduced ejection fraction.

Who is the study for?

This trial is for adults diagnosed with heart failure where the heart has a reduced ability to pump blood (LVEF ≤ 40%). Participants must not be on MRA therapy, should be registered in the Yale Heart Failure Registry, and are outpatients of certain clinics. Those with absolute contraindications to MRAs cannot join.

What is being tested?

The study tests if a 'best practice alert' system can increase prescriptions of MRAs for eligible patients by reminding doctors about this treatment option and providing information on managing high potassium levels that may prevent MRA use.

What are the potential side effects?

While this trial focuses on the implementation of an alert system rather than direct medication effects, MRAs themselves can cause side effects like high potassium levels, kidney issues, and hormonal changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am not taking any mineralocorticoid receptor antagonists (MRAs).

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot use MRAs due to severe side effects or risks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from one year prior to randomization up to randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from one year prior to randomization up to randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and from one year prior to randomization up to randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of patients with an active prescription for an MRA

Secondary study objectives

All-cause mortality

ED visit count

Frequency of outpatient potassium monitoring

+23 more

Other study objectives

Subgroup Analysis: Chronic Kidney Disease

Subgroup Analysis: GDMT medications

Subgroup Analysis: Hyperkalemia at randomization

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention - Best Practice AlertExperimental Treatment1 Intervention

Providers randomized to the intervention arm will have a best practice alert appear for each of their eligible patients upon opening of the order entry screen in the patient's medical record which alerts to the presence of HFrEF and the fact that the patient is not currently prescribed an MRA. A link to an order set for MRAs (or to potassium binders should a patient be hyperkalemic) will provided, along with a link to current best practices surrounding the use of MRAs.

Group II: Usual CareActive Control1 Intervention

Providers will not receive a best practice alert for eligible patients and will continue to care for patients as usual.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Best Practice Alert

2019

N/A

~14550

0 / 2Eligibility criteria met