Heart Failure With Reduced Ejection Fraction Clinical Trial
— ENIGMA-HFOfficial title:
Email Nudges to Improve GDMT (MRA) Adherence in Heart Failure
NCT number | NCT05806970 |
Other study ID # | UCLA IRB#23-000305 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2023 |
Est. completion date | July 2023 |
Verified date | April 2024 |
Source | University of California, Los Angeles |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The Email Nudges to Improve GDMT (MRA) Adherence in Heart Failure (ENIGMA-HF) study is a pragmatic parallel-arm randomized control trial of a quality improvement (QI) intervention involving email nudges to cardiology clinic managers to schedule appointments specific to guideline directed medical therapy (GDMT) initiation, with the goal of optimizing mineralocorticoid-receptor antagonist (MRA) use by patients with heart failure with reduced ejection fraction (HFrEF) cared for by cardiologists within the University of California, Los Angeles (UCLA) Health System.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | July 2023 |
Est. primary completion date | July 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Facility: UCLA Health System - Patient is 18 years of age or older - Patient is under the care of a UCLA cardiologist - Patient has a primary diagnosis of HFrEF - Patient is not currently prescribed an MRA Exclusion Criteria: - Hyperkalemia - Chronic kidney disease stage 4 or higher - Pregnant or breastfeeding patients - Heart transplant or ventricular-assist device patients - Hospice patients - Patients without an LVEF on file - Patients with an EF >35% |
Country | Name | City | State |
---|---|---|---|
United States | University of California, Los Angeles | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Los Angeles |
United States,
Brownell NK, Ziaeian B, Fonarow GC. The Gap to Fill: Rationale for Rapid Initiation and Optimal Titration of Comprehensive Disease-modifying Medical Therapy for Heart Failure with Reduced Ejection Fraction. Card Fail Rev. 2021 Nov 26;7:e18. doi: 10.15420/cfr.2021.18. eCollection 2021 Mar. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Percentage of eligible patients who have an appointment scheduled or indication changed in 60 days | Proportion of patients that have an appointment actively scheduled or an appointment indication actively changed within 60 days of study initiation. | 60 days | |
Other | Percentage of eligible patients who have an appointment scheduled in 60 days | Proportion of patients that have an appointment actively scheduled within 60 days of study initiation. | 60 days | |
Other | Percentage of eligible patients who have an appointment indication changed in 60 days | Proportion of patients that have an appointment already scheduled within 60 days of study initiation, but have the indication changed to "GDMT initiation - consider MRA." | 60 days | |
Other | Percentage of eligible patients who have a BMP ordered after MRA initiation | Safety endpoint: Proportion of patients that receive an active order for a basic metabolic panel (BMP) after being prescribed a mineralocorticoid receptor antagonist (MRA) | 60 days | |
Primary | Percentage of eligible patients prescribed MRA | Proportion of patients that receive an active prescription for mineralocorticoid receptor antagonist (MRA) compared between arms at the end of the study. | 60 days | |
Secondary | Percentage of eligible patients prescribed ACE/ARB/ARNI, beta blocker, or SGLT2i | Proportion of patients that receive an active prescription for angiotensin-converting enzyme inhibitor (ACE), angiotensin II receptor blocker (ARB), angiotensin receptor neprilysin inhibitor (ARNI), beta blocker, or sodium-glucose cotransporter-2 inhibitor (SGLT2i) compared between arms at the end of the study. | 60 days | |
Secondary | Percentage of eligible patients prescribed ACE/ARB/ARNI | Proportion of patients that receive an active prescription for angiotensin-converting enzyme inhibitor (ACE), angiotensin II receptor blocker (ARB), or angiotensin receptor neprilysin inhibitor (ARNI) compared between arms at the end of the study. | 60 days | |
Secondary | Percentage of eligible patients prescribed ARNI | Proportion of patients that receive an active prescription for angiotensin receptor neprilysin inhibitor (ARNI) compared between arms at the end of the study. | 60 days | |
Secondary | Percentage of eligible patients prescribed beta blocker | Proportion of patients that receive an active prescription for beta-blocker compared between arms at the end of the study. | 60 days | |
Secondary | Percentage of eligible patients prescribed SGLT2i | Proportion of patients that receive an active prescription for sodium-glucose cotransporter-2 inhibitor (SGLT2i) compared between arms at the end of the study. | 60 days |
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