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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
Adults equal to or greater than 18 years of age
Not currently prescribed an MRA
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from one year prior to randomization up to randomization
Awards & highlights

PROMPT-MRA Trial 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.Check my eligibility
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.See study design
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.

PROMPT-MRA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I am not taking any mineralocorticoid receptor antagonists (MRAs).

PROMPT-MRA Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of patients with an active prescription for an MRA
Secondary outcome measures
All-cause mortality
ED visit count
Frequency of outpatient potassium monitoring
+23 more
Other outcome measures
Subgroup Analysis: Chronic Kidney Disease
Subgroup Analysis: GDMT medications
Subgroup Analysis: Hyperkalemia at randomization
+5 more

PROMPT-MRA 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
~13340

Find a Location

Who is running the clinical trial?

Relypsa, Inc.Industry Sponsor
11 Previous Clinical Trials
1,306 Total Patients Enrolled
3 Trials studying Heart Failure
231 Patients Enrolled for Heart Failure
Yale UniversityLead Sponsor
1,837 Previous Clinical Trials
2,727,203 Total Patients Enrolled
31 Trials studying Heart Failure
53,889 Patients Enrolled for Heart Failure
Vifor PharmaIndustry Sponsor
54 Previous Clinical Trials
1,128,942 Total Patients Enrolled
7 Trials studying Heart Failure
6,553 Patients Enrolled for Heart Failure

Media Library

Best Practice Alert Clinical Trial Eligibility Overview. Trial Name: NCT04903717 — N/A
Heart Failure Research Study Groups: Intervention - Best Practice Alert, Usual Care
Heart Failure Clinical Trial 2023: Best Practice Alert Highlights & Side Effects. Trial Name: NCT04903717 — N/A
Best Practice Alert 2023 Treatment Timeline for Medical Study. Trial Name: NCT04903717 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this investigation currently seeking participants?

"This clinical trial, which was first published on November 3rd 2021 is now actively seeking participants. The details of the trial have been updated most recently on November 1st 2022 according to information found on clinicaltrials.gov."

Answered by AI

To what extent is participation in this trial limited?

"Affirmative. According to clinicaltrials.gov, the trial is currently enlisting participants since it was initially published on November 3rd 2021 and its last update occurred on November 1st 2022. To date 1210 potential candidates are being accepted at a single location."

Answered by AI
~363 spots leftby Mar 2025