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Behavioural Intervention
SmartHF Application for Heart Failure (SmartHF Trial)
Phase 3
Recruiting
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least two eligible heart failure therapies (guideline-recommended BB, RASI, MRA, or SGLT2i) not yet initiated or below 50% of the target dose
Age 18 years and older at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up over 12 weeks
Awards & highlights
SmartHF Trial Summary
This trial will investigate if a web application can help optimize medication for people with heart failure.
Who is the study for?
This trial is for adults over 18 with heart failure (HFrEF) and a left ventricular ejection fraction of 40% or less. They should be on less than half the target dose of certain heart medications, have internet access, speak English, and not be under advanced HF specialist care. Excluded are those in end-stage HF, on dialysis, with active cancer (except skin), pregnant women, those with implanted heart devices or on chronic inotropic drugs.Check my eligibility
What is being tested?
The SmartHF study tests an adaptive web app designed to help HFrEF patients manage their medication better using their electronic health records. Over 12 weeks at multiple centers, participants will either use this SmartHF application or receive standard care without it; they're randomly assigned to one of these two groups equally.See study design
What are the potential side effects?
Since the intervention is a web application aimed at optimizing medication use rather than a drug itself, there are no direct side effects like you'd expect from medication. However, users may experience issues related to technology use such as privacy concerns or stress due to misinterpretation of information.
SmartHF Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not on full doses of at least two recommended heart failure medications.
Select...
I am 18 years old or older.
Select...
My heart's pumping ability is reduced (LVEF ≤ 40%).
SmartHF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ over 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary Endpoint: Change in GDMT medication score
Secondary outcome measures
Secondary Endpoint: Level of agreement between the medication optimization algorithm recommendations and actual GDMT prescribed
SmartHF Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: SmartHF applicationExperimental Treatment1 Intervention
The web application-based study intervention provides adaptive medication recommendations that can be shared with their HF provider.
Group II: Control - Patients Standard Medication(s)Active Control1 Intervention
No change to current medication(s)
Find a Location
Who is running the clinical trial?
Henry Ford Hospital, Detroit, MIUNKNOWN
University of MichiganLead Sponsor
1,798 Previous Clinical Trials
6,377,913 Total Patients Enrolled
25 Trials studying Heart Failure
11,891 Patients Enrolled for Heart Failure
Emory University, Grady Hospital, Atlanta, GAUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You need to meet at least two of these conditions: blood pressure over 110mmg, potassium under 5.5, creatinine under 2.5, or heart rate over 70.I am not on full doses of at least two recommended heart failure medications.I am considered a candidate for hospice care due to end-stage heart failure.I am on dialysis.I am 18 years old or older.I am currently receiving treatment for cancer, not including non-melanoma skin cancer.You have a ventricular assist device implanted.I am currently on long-term medication to strengthen my heart muscle.Your doctor specializes in treating advanced heart failure.My heart's pumping ability is reduced (LVEF ≤ 40%).
Research Study Groups:
This trial has the following groups:- Group 1: Control - Patients Standard Medication(s)
- Group 2: SmartHF application
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can individuals currently access this clinical experiment?
"The clinicaltrial.gov page for this trial reveals that it is not actively recruiting patients, as the last update was on May 10th 2023. However, there are currently 729 other trials which require participants at this particular moment in time."
Answered by AI
How hazardous is the SmartHF program to clinical users?
"Our team has assigned SmartHF application a score of 3, indicating that there is ample evidence to suggest it's efficacy and safety from prior clinical trials."
Answered by AI
Who else is applying?
What state do they live in?
Georgia
What site did they apply to?
Emory University, Grady Hospital
Washington University, Barns Jewish Hospital
What portion of applicants met pre-screening criteria?
Met criteria
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