Heart Failure With Reduced Ejection FractionPROMPT-MRANCT04903717
Pragmatic Trial Of Alerts for Use of Mineralocorticoid Receptor Antagonists
A study testing Best Practice Alert in people with Heart Failure With Reduced Ejection Fraction, run by Yale University at 1 site in United States.
Trial summary
The primary objective of this study is to determine if a best practice alert (BPA) system that prompts providers to consider the addition of a mineralocorticoid receptor antagonist (MRA) in eligible patients with heart failure with reduced ejection fraction (HFrEF) will result in increased prescription of this… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction
- What is being tested?
- Best Practice Alert
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,210 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2021to 6 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults equal to or greater than 18 years of age
- Outpatients of providers randomized into the study within Internal Medicine and Cardiology outpatient clinics
- Diagnosis of heart failure with reduced ejection fraction (LVEF less than or equal to 40% on the most recent TTE)
- Registration in the Yale Heart Failure Registry (NCT04237701)
- Not currently prescribed an MRA
Who cannot join
- Absolute contraindication to MRAs
Trial locations and contacts
1 site in 1 country.
United States1 site
Cardiology/Internal Medicine Outpatient Clinics of Yale New Health System
New Haven, Connecticut, 06510
About this study
Official title: Pragmatic Trial Of Messaging to Providers About Treatment With Mineralocorticoid Receptor Antagonists
The primary objective of this study is to determine if a best practice alert (BPA) system that prompts providers to consider the addition of a mineralocorticoid receptor antagonist (MRA) in eligible patients with heart failure with reduced ejection fraction (HFrEF) will result in increased prescription of this guideline-recommended therapy. The system will also inform providers about FDA-approved potassium binders for the treatment of hyperkalemia if elevated potassium is a barrier for MRA use and will provide educational information on the evidence for MRA therapy in these patients.
Read the detailed description
Despite the robust literature demonstrating improved outcomes with the use of mineralocorticoid antagonists (MRAs) in patients with heart failure with reduced ejection fraction (HFrEF), MRAs continue to be underused in clinical practice. This underuse often stems from the perceived risks of hyperkalemia, including a prior history of hyperkalemia and acute or chronic kidney disease, as well as the cautioned use for those with potassium greater than 5.0 mEq/L, as recommended in national societal guidelines. New potassium binders have recently been approved by the United States Food and Drug Administration (FDA) to treat hyperkalemia. It remains unknown if a best practice alert built into the clinical electronic health record can facilitate MRA prescription in eligible patients by providing guideline-based information about MRA recommendations and evidence, as well as informing practitioners about available treatments for hyperkalemia.
This is a pragmatic, cluster-randomized, open-label interventional trial to test the comparative effectiveness of an EHR BPA system that informs practitioners about MRAs for HFrEF and, if necessary, potassium-binders that are FDA-approved for hyperkalemia, versus usual care (no alert, current standard of care). One hundred and fifty outpatient Cardiology and Internal Medicine providers (to include physicians and advanced practice providers (nurse practitioners, physician assistants, and advanced practice registered nurses)) practicing at affiliated locations will be enrolled and undergo randomization to either the intervention (alert) group or a control (usual care) group. Those in the intervention group will receive an informational alert for their eligible adult outpatients (those with HFrEF not currently prescribed an MRA). Those in the control group will not receive any alerts and will continue to care for patients as usual. The primary outcome will be the proportion of patients with HFrEF who have an active prescription for an MRA at 6 months following randomization.
- Being tested
- Best Practice Alert
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best Practice AlertBehavioural
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. This alert informs the provider to the presence of HFrEF and absence of MRA prescription, notes the patient's current LVEF, and notes the most recent labs, including NT-ProBNP, potassium, and creatinine. Providers will also have access to a link to best available guideline recommended information regarding use of MRAs and a link to both an order set for prescribing an MRA and an alternate order set with option for potassium monitoring should hyperkalemia be a concern. If a patient is hyperkalemic (i.e. K ≥ 5 mEq/L), a link to an order set for prescribing a potassium binder will be provided instead. If a provider feels that the recommended therapy is not indicated for a particular patient, he/she can select an available reason from the list provided within the alert.
| Study group | Role | What they receive |
|---|---|---|
| Intervention - Best Practice Alert | Experimental | 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. Receives: Behavioral: Best Practice Alert |
| Usual Care | No intervention | Providers will not receive a best practice alert for eligible patients and will continue to care for patients as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with an active prescription for an MRA
Proportion of patients with an active prescription for an MRA, defined as a prescription present in the electronic health record for any drug in the MRA class that is active (not expired) and has remaining doses left at 6 months after the date of randomization.
Measured: Measured at 6 months post-randomization
Secondary outcomes (56)
Number of MRA prescriptions
Number of any MRA prescription during study period.
Measured: Within one year post randomization
Percentage of MRA prescriptions filled
Percentage of prescriptions filled of initial MRA prescriptions written during the study period.
Measured: Within 30 days of written prescription
Time to first MRA prescription
Time (in days) to first MRA prescription
Measured: From enrollment to time of MRA prescription
Percentage of patients with Hyperkalemia (K>5.0)
Percentage of patients experiencing hyperkalemia (K greater than or equal to 5.0 mEq/L)
Measured: Within one year post randomization
Percentage of patients with Hyperkalemia (K>5.5)
Percentage of patients experiencing hyperkalemia (K greater than or equal to 5.5 mEq/L)
Measured: Within one year post randomization
Percentage of patients with Hyperkalemia (K>5.0) with MRA
Percentage of patients experiencing hyperkalemia (K greater than or equal to 5.0 mEq/L) with an active MRA prescription
Measured: Within one year post randomization
Percentage of patients with Hyperkalemia (K>5.5) with MRA
Percentage of patients experiencing hyperkalemia (K greater than or equal to 5.5 mEq/L) with an active MRA prescription
Measured: Within one year post randomization
Percentage of patients with potassium binder prescription
Percentage of participants with active prescription for potassium binders
Measured: Measured at 1 month post randomization
Percentage of patients with potassium binder prescription
Percentage of participants with active prescription for potassium binders
Measured: Measured at 2 months post randomization
Percentage of patients with potassium binder prescription
Percentage of participants with active prescription for potassium binders
Measured: Measured at 3 months post randomization
Percentage of patients with potassium binder prescription
Percentage of participants with active prescription for potassium binders
Measured: Measured at 4 months post randomization
Percentage of patients with potassium binder prescription
Percentage of participants with active prescription for potassium binders
Measured: Measured at 5 months post randomization
Percentage of patients with potassium binder prescription
Percentage of participants with active prescription for potassium binders
Measured: Measured at 6 months post randomization
Percentage of patients with potassium binder + MRA prescription
Percentage of participants with active prescription for potassium binders and MRA
Measured: Measured at 1 month post randomization
Percentage of patients with potassium binder + MRA prescription
Percentage of participants with active prescription for potassium binders and MRA
Measured: Measured at 2 months post randomization
Percentage of patients with potassium binder + MRA prescription
Percentage of participants with active prescription for potassium binders and MRA
Measured: Measured at 3 months post randomization
Percentage of patients with potassium binder + MRA prescription
Percentage of participants with active prescription for potassium binders and MRA
Measured: Measured at 4 months post randomization
Percentage of patients with potassium binder + MRA prescription
Percentage of participants with active prescription for potassium binders and MRA
Measured: Measured at 5 months post randomization
Percentage of patients with potassium binder + MRA prescription
Percentage of participants with active prescription for potassium binders and MRA
Measured: Measured at 6 months post randomization
Type of potassium binder prescribed
Type of first potassium binder prescribed
Measured: First potassium binder prescribed at any point between enrollment and study completion
Rationale for provider not prescribing an MRA if indicated (intervention group only)
Provider-documented (via the best practice alert) rationale for not prescribing indicated MRA (intervention group only)
Measured: Any rationale provided within one year post randomization
Rationale for provider not prescribing a potassium binder if indicated (intervention group only)
Provider-documented (via the best practice alert) rationale for not prescribing indicated potassium binder (intervention group only)
Measured: Any rationale provided within one year post randomization
Percentage of patients with ED visits
Percentage of patients with any ED visit
Measured: Measured at 1 month post randomization
Percentage of patients with ED visits
Percentage of patients with any ED visit
Measured: Measured at 3 months post randomization
Percentage of patients with ED visits
Percentage of patients with any ED visit
Measured: Measured at 6 months post randomization
Percentage of patients with ED visits
Percentage of patients with any ED visit
Measured: Measured at 12 months post randomization
ED visit count
Count of ED visits per patient
Measured: Measured at 1 month post randomization
ED visit count
Count of ED visits per patient
Measured: Measured at 3 months post randomization
ED visit count
Count of ED visits per patient
Measured: Measured at 6 months post randomization
ED visit count
Count of ED visits per patient
Measured: Measured at 12 months post randomization
Rates of Heart failure-related hospital admissions
Rates of HF-related hospital admissions (uses computations phenotype)
Measured: Measured at 1 month post randomization
Rates of Heart failure-related hospital admissions
Rates of HF-related hospital admissions (uses computations phenotype)
Measured: Measured at 3 months post randomization
Rates of Heart failure-related hospital admissions
Rates of HF-related hospital admissions (uses computations phenotype)
Measured: Measured at 6 months post randomization
Rates of Heart failure-related hospital admissions
Rates of HF-related hospital admissions (uses computations phenotype)
Measured: Measured at 12 months post randomization
Rates Outpatient visits
Rates of outpatient visits
Measured: Measured at 1 monnh post randomization
Rate of Outpatient visits
Rates of outpatient visits
Measured: Measured at 3 months post randomization
Rate of Outpatient visits
Rates of outpatient visits
Measured: Measured at 6 months post randomization
Rate of Outpatient visits
Rates of outpatient visits
Measured: Measured at 12 months post randomization
Rate of ED visit + IV diuretics
Rates of total ED visits in which a dose of IV diuretics was given
Measured: Measured at 1 month post randomization
Rate of ED visit + IV diuretics
Rates of total ED visits in which a dose of IV diuretics was given
Measured: Measured at 3 months post randomization
Rate of ED visit + IV diuretics
Rates of total ED visits in which a dose of IV diuretics was given
Measured: Measured at 6 months post randomization
Rate of ED visit + IV diuretics
Rates of total ED visits in which a dose of IV diuretics was given
Measured: Measured at 12 months post randomization
All-cause mortality
Rates of all-cause mortality
Measured: Measured at 1 month post randomization
All-cause mortality
Rates of all-cause mortality
Measured: Measured at 3 months post randomization
All-cause mortality
Rates of all-cause mortality
Measured: Measured at 6 months post randomization
All-cause mortality
Rates of all-cause mortality
Measured: Measured at 12 months post randomization
Total healthcare associated costs
Total healthcare-associated cost per patient
Measured: Measured at 1 month post randomization
Total healthcare associated costs
Total healthcare-associated cost per patient
Measured: Measured at 3 months post randomization
Total healthcare associated costs
Total healthcare-associated cost per patient
Measured: Measured at 6 months post randomization
Total healthcare associated costs
Total healthcare-associated cost per patient
Measured: Measured at 12 months post randomization
Rates of documented hyperkalemia at an ED visit
Documented hyperkalemia (K ≥ 5.5 mEq/L) at an ED visit
Measured: Within one year post randomization
Rates of documented hyperkalemia at an outpatient visit
Documented hyperkalemia (K ≥ 5.5 mEq/L) at an outpatient visit
Measured: Within one year post randomization
Rates of documented hyperkalemia during a hospital HF admission
Documented hyperkalemia (K ≥ 5.5 mEq/L) at an HF-related hospital admission
Measured: Within one year post randomization
Frequency of outpatient potassium monitoring
Frequency of outpatient potassium monitoring
Measured: Within one year post randomization
Frequency of outpatient potassium monitoring +/- MRA
Frequency of outpatient potassium monitoring for those with an active prescription of MRA vs. not
Measured: Within one year post randomization
Frequency of outpatient potassium monitoring +/- potassium binder
Frequency of outpatient potassium monitoring for those with an active prescription of potassium binder vs. not
Measured: Within one year post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start3 Nov 2021
- Primary completion6 Aug 2023
- Study completion6 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Vifor Pharma, Relypsa, Inc.
- Responsible party
- Sponsor
- Investigators
- Francis P Wilson, MD MSCE, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04903717
- Sponsor's protocol ID
- 2000030513
- Acronym
- PROMPT-MRA
- Status last verified
- Aug 2024
- First submitted
- 21 May 2021
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data underlying results for publication will be shared upon publication.
Publications
Clark KAA, Victoria-Castro AM, Ghazi L, Yamamoto Y, Coronel-Moreno C, Kadhim BA, Riello RJ 3rd, O'Connor K, Ahmad T, Wilson FP, Desai NR. Rationale, Design, and Patient Characteristics of a Cluster-Randomized Pragmatic Trial to Improve Mineralocorticoid Antagonist Use. JACC Heart Fail. 2024 Feb;12(2):322-332. doi: 10.1016/j.jchf.2023.08.025. Epub 2023 Nov 8.
PubMed 37943221
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Trial Of Messaging to Providers About Treatment With Mineralocorticoid Receptor Antagonists
- ClinicalTrials.gov ID
- NCT04903717
- Acronym / sponsor ID
- PROMPT-MRA / 2000030513
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,210 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Vifor Pharma, Relypsa, Inc.
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- 6 Aug 2023 (actual)
- Study completion
- 6 Feb 2024 (actual)
- First posted
- 26 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to determine if a best practice alert (BPA) system that prompts providers to consider the addition of a mineralocorticoid receptor antagonist (MRA) in eligible patients with heart failure with reduced ejection fraction (HFrEF) will result in increased prescription of this guideline-recommended therapy. The system will also inform providers about FDA-approved potassium binders for the treatment of hyperkalemia if elevated potassium is a barrier for MRA use and will provide educational information on the evidence for MRA therapy in these patients.
Detailed description
Despite the robust literature demonstrating improved outcomes with the use of mineralocorticoid antagonists (MRAs) in patients with heart failure with reduced ejection fraction (HFrEF), MRAs continue to be underused in clinical practice. This underuse often stems from the perceived risks of hyperkalemia, including a prior history of hyperkalemia and acute or chronic kidney disease, as well as the cautioned use for those with potassium greater than 5.0 mEq/L, as recommended in national societal guidelines. New potassium binders have recently been approved by the United States Food and Drug Administration (FDA) to treat hyperkalemia. It remains unknown if a best practice alert built into the clinical electronic health record can facilitate MRA prescription in eligible patients by providing guideline-based information about MRA recommendations and evidence, as well as informing practitioners about available treatments for hyperkalemia.
This is a pragmatic, cluster-randomized, open-label interventional trial to test the comparative effectiveness of an EHR BPA system that informs practitioners about MRAs for HFrEF and, if necessary, potassium-binders that are FDA-approved for hyperkalemia, versus usual care (no alert, current standard of care). One hundred and fifty outpatient Cardiology and Internal Medicine providers (to include physicians and advanced practice providers (nurse practitioners, physician assistants, and advanced practice registered nurses)) practicing at affiliated locations will be enrolled and undergo randomization to either the intervention (alert) group or a control (usual care) group. Those in the intervention group will receive an informational alert for their eligible adult outpatients (those with HFrEF not currently prescribed an MRA). Those in the control group will not receive any alerts and will continue to care for patients as usual. The primary outcome will be the proportion of patients with HFrEF who have an active prescription for an MRA at 6 months following randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention - Best Practice Alert | Experimental | Behavioral: Best Practice AlertProviders 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. |
| Usual Care | No intervention | –Providers will not receive a best practice alert for eligible patients and will continue to care for patients as usual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults equal to or greater than 18 years of age
- Outpatients of providers randomized into the study within Internal Medicine and Cardiology outpatient clinics
- Diagnosis of heart failure with reduced ejection fraction (LVEF less than or equal to 40% on the most recent TTE)
- Registration in the Yale Heart Failure Registry (NCT04237701)
- Not currently prescribed an MRA
Key exclusion criteria (1 listed)
- Absolute contraindication to MRAs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best Practice AlertProviders 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. This alert informs the provider to the presence of HFrEF and absence of MRA prescription, notes the patient's current LVEF, and notes the most recent labs, including NT-ProBNP, potassium, and creatinine. Providers will also have access to a link to best available guideline recommended information regarding use of MRAs and a link to both an order set for prescribing an MRA and an alternate order set with option for potassium monitoring should hyperkalemia be a concern. If a patient is hyperkalemic (i.e. K ≥ 5 mEq/L), a link to an order set for prescribing a potassium binder will be provided instead. If a provider feels that the recommended therapy is not indicated for a particular patient, he/she can select an available reason from the list provided within the alert. | Behavioural | Intervention - Best Practice Alert |
Primary outcome
Proportion of patients with an active prescription for an MRA
Time frame: Measured at 6 months post-randomization
Proportion of patients with an active prescription for an MRA, defined as a prescription present in the electronic health record for any drug in the MRA class that is active (not expired) and has remaining doses left at 6 months after the date of randomization.
56 secondary outcomes
Number of MRA prescriptions
Time frame: Within one year post randomization
Percentage of MRA prescriptions filled
Time frame: Within 30 days of written prescription
Time to first MRA prescription
Time frame: From enrollment to time of MRA prescription
Percentage of patients with Hyperkalemia (K>5.0)
Time frame: Within one year post randomization
Percentage of patients with Hyperkalemia (K>5.5)
Time frame: Within one year post randomization
Percentage of patients with Hyperkalemia (K>5.0) with MRA
Time frame: Within one year post randomization
Percentage of patients with Hyperkalemia (K>5.5) with MRA
Time frame: Within one year post randomization
Percentage of patients with potassium binder prescription
Time frame: Measured at 1 month post randomization
Percentage of patients with potassium binder prescription
Time frame: Measured at 2 months post randomization
Percentage of patients with potassium binder prescription
Time frame: Measured at 3 months post randomization
Percentage of patients with potassium binder prescription
Time frame: Measured at 4 months post randomization
Percentage of patients with potassium binder prescription
Time frame: Measured at 5 months post randomization
Percentage of patients with potassium binder prescription
Time frame: Measured at 6 months post randomization
Percentage of patients with potassium binder + MRA prescription
Time frame: Measured at 1 month post randomization
Percentage of patients with potassium binder + MRA prescription
Time frame: Measured at 2 months post randomization
Percentage of patients with potassium binder + MRA prescription
Time frame: Measured at 3 months post randomization
Percentage of patients with potassium binder + MRA prescription
Time frame: Measured at 4 months post randomization
Percentage of patients with potassium binder + MRA prescription
Time frame: Measured at 5 months post randomization
Percentage of patients with potassium binder + MRA prescription
Time frame: Measured at 6 months post randomization
Type of potassium binder prescribed
Time frame: First potassium binder prescribed at any point between enrollment and study completion
Rationale for provider not prescribing an MRA if indicated (intervention group only)
Time frame: Any rationale provided within one year post randomization
Rationale for provider not prescribing a potassium binder if indicated (intervention group only)
Time frame: Any rationale provided within one year post randomization
Percentage of patients with ED visits
Time frame: Measured at 1 month post randomization
Percentage of patients with ED visits
Time frame: Measured at 3 months post randomization
Percentage of patients with ED visits
Time frame: Measured at 6 months post randomization
Percentage of patients with ED visits
Time frame: Measured at 12 months post randomization
ED visit count
Time frame: Measured at 1 month post randomization
ED visit count
Time frame: Measured at 3 months post randomization
ED visit count
Time frame: Measured at 6 months post randomization
ED visit count
Time frame: Measured at 12 months post randomization
Rates of Heart failure-related hospital admissions
Time frame: Measured at 1 month post randomization
Rates of Heart failure-related hospital admissions
Time frame: Measured at 3 months post randomization
Rates of Heart failure-related hospital admissions
Time frame: Measured at 6 months post randomization
Rates of Heart failure-related hospital admissions
Time frame: Measured at 12 months post randomization
Rates Outpatient visits
Time frame: Measured at 1 monnh post randomization
Rate of Outpatient visits
Time frame: Measured at 3 months post randomization
Rate of Outpatient visits
Time frame: Measured at 6 months post randomization
Rate of Outpatient visits
Time frame: Measured at 12 months post randomization
Rate of ED visit + IV diuretics
Time frame: Measured at 1 month post randomization
Rate of ED visit + IV diuretics
Time frame: Measured at 3 months post randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Derived from this study: PubMed 37943221Clark KAA, Victoria-Castro AM, Ghazi L, Yamamoto Y, Coronel-Moreno C, Kadhim BA, Riello RJ 3rd, O'Connor K, Ahmad T, Wilson FP, Desai NR. Rationale, Design, and Patient Characteristics of a Cluster-Randomized Pragmatic Trial to Improve Mineralocorticoid Antagonist Use. JACC Heart Fail. 2024 Feb;12(2):322-332. doi: 10.1016/j.jchf.2023.08.025. Epub 2023 Nov 8.
- Individual participant dataSharing planned: Yes. Deidentified data underlying results for publication will be shared upon publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francis P Wilson, MD MSCE principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice Alert in people with Heart Failure With Reduced Ejection Fraction, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with an active prescription for an MRA (time frame: Measured at 6 months post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04903717, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.