Using a web app to optimize heart failure medication
The Impact of an Adaptive Patient-centered Web Application on Medication Optimization in HFrEF Patients (SmartHF)
This study tests if a web app can help people with heart failure manage their medications better than standard care over 12 weeks.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 225 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 5 sites (Atlanta, Georgia and 4 other locations) |
| Trial ID | NCT05858320 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a web application called SmartHF designed to help patients with heart failure optimize their medication. Over 12 weeks, participants will be randomly assigned to either use the web application or receive standard care. The app analyzes electronic health record data to provide personalized medication recommendations that patients can discuss with their healthcare providers. The goal is to improve adherence to guideline-directed medical therapy for patients with heart failure and reduced ejection fraction.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with heart failure with reduced ejection fraction and who have access to the internet and their health system's patient portal.
Not a fit: Patients with end-stage heart failure, advanced heart failure specialists as their providers, or those currently on chronic inotropic therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better medication management and improved health outcomes for heart failure patients.
How similar studies have performed: Other studies have shown promise in using digital health tools for medication management, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18 years and older at screening 2. Diagnosis of heart failure with a left ventricular ejection fraction (LVEF) \</= 40% (HFrEF) 3. Have a general medicine provider or general cardiology provider for HFrEF 4. Have internet access and access to their health system's patient portal 5. Fluent in spoken and written English 6. At least two of the following: systolic blood pressure ≥ 110mmg, potassium ≤ 5.5, serum creatinine ≤ 2.5, heart rate ≥ 70 7. At least two eligible heart failure therapies (guideline-recommended BB, RASI, MRA, or SGLT2i) not yet initiated or below 50% of the target dose Exclusion Criteria: 1. End-stage HF (hospice candidate) 2. Actively treated cancer, except non-melanoma skin cancer 3. Implanted ventricular assist device 4. Current treatment with chronic inotropic therapy 5. Patient's provider for HFrEF care is considered an advanced HF specialist 6. Currently pregnant or intends to become pregnant during the study period 7. Dialysis
Where this trial is running
Atlanta, Georgia and 4 other locations
- Emory University, Grady Hospital — Atlanta, Georgia, United States (Recruiting)
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
- Henry Ford Hospital and Health System — Detroit, Michigan, United States (Recruiting)
- Trinity Healthcare St. Joseph Mercy Ann Arbor — Ypsilanti, Michigan, United States (Recruiting)
- Washington University, Barns Jewish Hospital — Saint Louis, Missouri, United States (Recruiting)
Study contacts
- Study coordinator: Mike Dorsch, PharmD, MS
- Email: mdorsch@med.umich.edu
- Phone: 734-647-1452
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.