StudyU App + Beta Blockers for Heart Failure

(N-of-1 App Trial)

Age: 65+

Sex: Any

Trial Phase: Phase 4

Sponsor: Weill Medical College of Cornell University

Must be taking: Beta blockers

Disqualifiers: Decompensated HF, Hospitalized, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6-18 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a phone app called StudyU can help individuals with heart failure manage their beta blocker medication more effectively. The focus is on those with Heart Failure with Reduced Ejection Fraction (HFrEF), where the heart doesn't pump as efficiently as it should. Participants will use the app to adjust their medication doses under guidance to see if they can reach the recommended levels. This trial is suitable for individuals on beta blockers who have not yet reached the highest dose recommended by their doctor and have access to a smartphone or tablet. As a Phase 4 trial, this research involves an FDA-approved treatment and seeks to understand how it can benefit more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it seems you need to be stable on your current beta blocker dose before joining. If your medications have changed in the last 14 days, you might not be eligible.

What is the safety track record for these treatments?

Studies have shown that beta blockers are generally safe for people with heart failure where the heart doesn't pump as well as it should (HFrEF). They reduce the risk of death and the need for hospital visits in these patients, allowing many to use them without problems.

The StudyU app is a new tool designed to help manage heart failure from home. Research indicates that digital tools like StudyU are safe and can enhance heart failure management for doctors and patients.

Overall, past studies have demonstrated that both beta blockers and the StudyU app are safe options for managing heart failure. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about this trial because it pairs the standard beta-blocker treatment for heart failure with the StudyU app, offering a unique approach to managing the condition. Unlike traditional treatments that rely solely on fixed doses, this trial explores adaptive dosing, adjusting based on real-time feedback from the StudyU app. This method could lead to more personalized care, allowing for more precise titration of beta-blockers in response to individual patient needs and symptoms. Additionally, the remote monitoring and assessments provide convenience and potentially better adherence to treatment plans.

What evidence suggests that the StudyU app and beta blockers are effective for heart failure?

Research has shown that beta blockers benefit people with heart failure with reduced ejection fraction (HFrEF). These medications help the heart pump blood more effectively, improving blood flow and reducing symptoms. Studies have found that beta blockers can significantly decrease the chances of hospitalization and death in heart failure patients. By slowing down the heart rate, they ease the heart's workload. This trial will explore how a mobile app, StudyU, might assist patients in finding the right dose of beta blockers. While specific data on this app is not yet available, similar self-management tools have shown promise in improving health outcomes for heart failure patients. ^{6 7 8 9 10}

Who Is on the Research Team?

Parag Goyal, MD, MSc

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for adults aged 65 or older with Heart Failure with Reduced Ejection Fraction (HFrEF), who are not on the maximum dose of beta blockers as per their doctor's advice, and have access to a smartphone. People with severe dementia, life expectancy less than 6 months, recent hospitalization, or those in another clinical trial cannot participate.

Inclusion Criteria

Access to a smartphone or device with touchscreen interface, internet access, and an operating system capable of running downloaded applications

My heart's pumping ability is reduced, with an ejection fraction below 50%.

I am on a lower dose of beta blocker as advised by my doctor.

Exclusion Criteria

Do not have access to a smartphone or tablet

Estimated life expectancy <6 months

Moderate-severe dementia or psychiatric disorder precluding informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the StudyU app to conduct N-of-1 trials with beta-blockers, testing multiple doses to determine the maximally tolerated dose

6-18 weeks

Daily assessments via StudyU app, end of period assessments by phone, Zoom, or email

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Beta Blockers
• StudyU Application

Trial Overview The study tests if a phone app called StudyU can help HFrEF patients increase their dosage of beta blockers to the recommended level. It involves using the app alongside regular treatment.

How Is the Trial Designed?

Group I: GDMT (Beta Blockers) Experimental Treatment 2 Interventions

This study consists of a single arm. Subjects will complete study activities remotely. Following enrollment, daily assessments will be conducted using the StudyU mobile application. Additional assessments will occur at the end of each study period, completed by phone, WCM Zoom, or via email, depending on subject preference. The study involves testing multiple doses of each subject's guideline-directed medical therapy (GDMT), specifically beta-blockers. Doses will include the subject's current home dose (as prescribed by their treating physician prior to enrollment), as well as one or more increased -and, if needed, decreased-doses that are near or at the guideline-directed maximum. All dosing decisions will be made collaboratively by the PI, the subject's clinician, and the participant, taking into account titration guidelines, physician guidance, and subject symptoms and preferences. Each subject will complete a minimum of two periods. The number of periods is adaptive.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9015755/

The Use of Mobile Apps for Heart Failure Self-management This study aims to systematically review the evidence on the effect of heart failure self-management apps on health outcomes, patient-reported outcomes, and ...

2. ahajournals.org ahajournals.org/doi/10.1161/circheartfailure.112.971051

A Population-Based Study to Evaluate the Effectiveness of ... In this real-world population-based study, we found that multidisciplinary HF clinics are associated with a decrease in mortality, but an increase in ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT00873418

Coping Skills and Heart Failure: Outcomes and Mechanisms This study will evaluate whether heart failure patients receiving a 16 week telephone delivered, intervention using cognitive behavior therapy to facilitate ...

4. ajmc.com ajmc.com/view/clinical-outcomes-in-heart-failure-monitoring-a-pooled-rates-analysis

Clinical Outcomes in Heart Failure Monitoring: A Pooled ... This study aimed to pool comparable data and estimate the rates of clinical outcomes in the SOC monitoring arms of published RCTs. This was done ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2790702

Effectiveness and Cost-effectiveness of an Empowerment ... This randomized clinical trial compares self-care and cost-effectiveness outcomes between patients with heart failure who received an ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12477414/

Beta-Blockers in Heart Failure With Reduced Ejection ... Beta-blockers demonstrated significant reductions in all-cause mortality and heart failure hospitalizations in chronic HFrEF patients. In ...

7. nejm.org nejm.org/doi/full/10.1056/NEJMoa2512686

Beta-Blockers after Myocardial Infarction with Normal ... The REBOOT trial showed no effect of beta-blockers on the composite of death from any cause, myocardial infarction, or heart failure (hazard ...

8. jacc.org jacc.org/doi/10.1016/j.jchf.2023.09.007

Contemporary Use and Implications of Beta-Blockers in ... This study sought to examine the contemporary use and implications of beta-blockers in patients with heart failure with mildly reduced ejection fraction ( ...

9. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/1935124

β-Blockers and Outcomes in Patients With Heart Failure ... β-Blockers were not associated with reduced combined mortality or heart failure hospitalizations: 3368 (61%) vs 1753 (64%) total for first ...

10. nature.com nature.com/articles/s41598-025-17483-3

Beta blockers linked to reduced 1-Year mortality ... - Nature In contrast, the DELIVER trial, which included over 80% of participants on β blockers, demonstrated the reduced heart failure events and ...