SmartHF Application for Heart Failure

(SmartHF Trial)

Recruiting at 4 trial locations

Overseen By Kaitlyn Greer

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Michigan

Must be taking: BB, RASI, MRA, SGLT2i

Disqualifiers: End-stage HF, Cancer, Dialysis, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 1

225 Participants Needed

Trial Summary

What is the purpose of this trial?

The SmartHF study is a 12-week prospective randomized controlled multicenter clinical trial. This study will investigate the efficacy of an adaptive web application to facilitate guideline-directed medical therapy (GDMT) optimization in HFrEF patients. Eligible participants will be randomized to the web application intervention or control in a 1:1 manner, stratified by site. The intervention is an adaptive medication optimization web application that extracts and analyzes the EHR data with a computable medication optimization algorithm. The algorithm provides a medication quality score and outputs medication optimization recommendations written in a patient -friendly manner.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. However, it focuses on optimizing heart failure medications, so you may need to adjust your current doses or add new medications.

What data supports the effectiveness of the SmartHF application treatment for heart failure?

A study on a mobile-app based follow-up platform for heart failure patients showed that it was safe and effective, with increased use of important heart medications over 12 months, suggesting that similar app-based treatments like SmartHF could help manage heart failure. ^{1 2 3 4 5}

Is the SmartHF application safe for humans?

The research articles discuss adverse events and drug reactions in heart failure treatments, but they do not provide specific safety data for the SmartHF application. ^{6 7 8 9 10}

How is the SmartHF application treatment different from other heart failure treatments?

The SmartHF application is unique because it uses smartphone-based monitoring to detect heart failure symptoms early, allowing for low-cost and scalable management. It focuses on home telemonitoring and self-management, empowering patients to take an active role in their care. ^{11 12 13 14 15}

Eligibility Criteria

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.

Inclusion 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 18 years old or older.

Exclusion Criteria

I am considered a candidate for hospice care due to end-stage heart failure.

I am on dialysis.

I am currently receiving treatment for cancer, not including non-melanoma skin cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the SmartHF web application intervention or control up to 30 days before a clinic visit

4 weeks

1 visit (in-person)

Follow-up

Participants are monitored for changes in GDMT medication score and level of agreement between recommendations and actual GDMT prescribed

12 weeks

Treatment Details

Interventions

• SmartHF application

Trial Overview 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.

Participant Groups

Group I: SmartHF application Experimental Treatment 1 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 Control 1 Intervention

No change to current medication(s)

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Henry Ford Hospital, Detroit, MI

Collaborator

Trials

1

Recruited

230+

Emory University, Grady Hospital, Atlanta, GA

Collaborator

Trials

1

Recruited

230+

Washington University, Barns Jewish Hospital, St. Louis, MO

Collaborator

Trials

1

Recruited

230+

Findings from Research

A study of 1300 hospitalized heart failure patients in Poland showed improvements in care quality from 2005 to 2013, including better access to echocardiography and increased use of beta-blockers and mineralocorticoid receptor antagonists.

However, there was a notable decrease in the prescription of angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs), likely due to the aging patient population and a rise in comorbid conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of care of hospitalised patients with heart failure in Poland in 2013: results of the second nationwide survey. Fedyk-Łukasik, M., Wizner, B., Opolski, G., et al.[2017]

A novel prediction model using electronic health records (EHRs) from 2102 heart failure patients demonstrated an area under the ROC curve (AUC) of 0.744 for predicting composite endpoints, outperforming existing models like Long Short Term Memory and Gated Recurrent Unit.

The model utilized advanced learning strategies, including adversarial and multi-task learning, to optimize the prediction of heart failure readmission and all-cause mortality, indicating its potential for improving patient care and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endpoint prediction of heart failure using electronic health records. Chu, J., Dong, W., Huang, Z.[2021]

In a study of 110 patients with heart failure and reduced ejection fraction (HFrEF), the inclusion of clinical pharmacists in the healthcare team significantly increased the percentage of patients reaching target doses of key medications, such as ACE inhibitors and beta blockers, from 0% to 77.4% and from 8.6% to 66.1%, respectively.

The up-titration of these medications led to notable improvements in clinical outcomes, including better ejection fraction and enhanced scores on the New York Heart Association (NYHA) scale, demonstrating the effectiveness of pharmacist interventions in managing heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Pharmacist's Intervention to Improve Medication Titration for Heart Failure: First Experience from Sudan. Ahmed, KO., Taj Eldin, I., Yousif, M., et al.[2022]

In a pilot study involving 55 patients recently discharged from heart failure hospitalization, a mobile app-based follow-up platform significantly increased the use of renin-angiotensin system inhibitors from 76% to 91% over 12 months, indicating improved medication adherence.

The study demonstrated high usability of the app, with a remarkable 96% adherence rate to medication reported by patients, and only one hospitalization for heart failure during the follow-up period, suggesting that this telemedicine approach is safe and effective for managing heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a Telemedicine Program After a Heart Failure Hospitalization on 12 Months Follow-Up Events. Sosa Liprandi, MI., Elfman, M., Zaidel, EJ., et al.[2023]

The ATHENA-PT study identified key strategic recommendations for managing heart failure (HF) in Portugal, including the reimbursement of natriuretic peptide testing and improving healthcare transitions between hospital and outpatient care.

For prevention, experts suggested raising awareness of cardiovascular risk factors, promoting physical activity and healthy eating, and addressing therapeutic inertia in managing these risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expert perspectives on strategic factors for the management and prevention of heart failure in Portugal. Caldeira, D., Brito, D., Aguiar, C., et al.[2023]

In a study of 151 patients with systolic heart failure followed for about 10 months, treatment-related serious adverse events (SAEs) were common, but there was no significant difference in SAEs between those receiving NT-proBNP-guided care and standard care.

Patients who experienced SAEs had poorer quality of life and less improvement in heart function, and a risk score was developed to help predict which patients might be at higher risk for these adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization and prediction of adverse events from intensive chronic heart failure management and effect on quality of life: results from the pro-B-type natriuretic peptide outpatient-tailored chronic heart failure therapy (PROTECT) study. Gandhi, PU., Szymonifka, J., Motiwala, SR., et al.[2015]

Sacubitril-valsartan has been shown to significantly reduce cardiovascular mortality and hospitalizations related to heart failure, highlighting its efficacy as a new treatment option.

Other emerging therapies like ivabradine and ferric carboxymaltose have also proven effective in reducing hospitalizations for heart failure, indicating a promising expansion of treatment options for managing chronic heart failure and acute decompensated heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolving therapies for the management of chronic and acute decompensated heart failure. Cook, JC., Tran, RH., Patterson, JH., et al.[2021]

In a study of 261 heart failure patients, common adverse drug events (ADEs) included dizziness (26%) and dry mouth (24%), with nearly half of the patients perceiving these ADEs as serious and significantly impacting their daily lives.

Patients expressed a strong belief in healthcare providers' ability to manage ADEs, but many felt that these issues were chronic and caused emotional distress, highlighting the need for better communication between patients and providers regarding ADE management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceived adverse drug events in heart failure: patients' perception and related factors. De Smedt, RH., Haaijer-Ruskamp, FM., Groenier, KH., et al.[2011]

Among 511 heart failure patient admissions, 6.7% were due to adverse drug reactions (ADRs), with over one-third of these hospitalizations deemed preventable.

The study found that the number of medications taken by heart failure patients was a significant predictor of ADR-related hospitalizations, with diuretics being the most common drugs involved, leading to issues like volume depletion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug reaction-related hospitalisations among patients with heart failure at two hospitals in the United Arab Emirates. Saheb Sharif-Askari, N., Syed Sulaiman, SA., Saheb Sharif-Askari, F., et al.[2022]

Adverse drug events (ADEs) are common in older adults (over 75 years) receiving heart failure therapy, with 57% of studies reporting such events, particularly with beta blockers and spironolactone.

Factors like advanced age, poor left ventricular function, and higher New York Heart Association Class are associated with increased ADEs, indicating a need for careful monitoring in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug events and associated factors in heart failure therapy among the very elderly. Sztramko, R., Chau, V., Wong, R.[2021]

The SmartCare project demonstrated that telemedicine significantly reduced hospitalization days for patients with chronic diseases, particularly heart failure, by 20 days per 10 patient-months of follow-up.

Patients receiving telemonitoring had a notable increase in home care interventions and telephone contacts, indicating enhanced support and management of their conditions compared to those receiving usual care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Integrated social and health care supported by home telemonitoring in patients with heart failure: the European SmartCare project in the Friuli Venezia Giulia Region]. Radini, D., Apuzzo, G., Pellizzari, M., et al.[2021]

A pilot study involving 20 heart failure patients showed that a telemonitoring platform is feasible and well-accepted, with 75% of participants agreeing it improves patient care.

After using the telemonitoring system, patients demonstrated a significant increase in medication adherence, suggesting potential benefits for heart failure management that warrant further investigation in larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Telemonitoring and a real-time alert system in heart failure: a preliminary pilot study of feasibility, acceptability and efficacy]. Diez, M., Burgos, LM., Baro Vila, RC., et al.[2023]

A study involving 28 heart failure patients demonstrated that smartphone-based monitoring, which combined passive data (like movement and social interactions) and active surveys, can effectively predict heart failure decompensation events, achieving a high accuracy with an AUC of 0.83 for a 2-day prediction window.

The findings suggest that social data, such as the frequency and duration of phone calls, can provide valuable insights into a patient's health status, indicating that smartphone monitoring could be a cost-effective alternative to traditional monitoring methods for heart failure management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Passively Captured Interpersonal Social Interactions and Motion From Smartphones for Predicting Decompensation in Heart Failure: Observational Cohort Study. Cakmak, AS., Perez Alday, EA., Densen, S., et al.[2022]

A study of 100 heart failure patients revealed that 68% owned smartphones, with higher ownership rates among Black or African American and Hispanic or Latino patients compared to White patients, indicating a potential for mHealth technology adoption in these communities.

Participants expressed strong interest in using mHealth apps for self-monitoring key health metrics like physical activity, blood pressure, and medication adherence, suggesting that integrating these technologies could enhance heart failure self-management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone Ownership and Interest in Mobile Health Technologies for Self-care Among Patients With Chronic Heart Failure: Cross-sectional Survey Study. Leigh, JW., Gerber, BS., Gans, CP., et al.[2022]

Healthcare providers believe that smart home systems could enhance self-management for heart failure patients by enabling remote monitoring and support, which may help patients live independently at home.

However, there are concerns about the potential increased workload for healthcare providers and the usability of technology for older patients or those with disabilities, indicating a need for careful design that considers patient capabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthcare providers' perspectives on using smart home systems to improve self-management and care in people with heart failure: A qualitative study. Islam, SMS., Halooq, A., Dening, J., et al.[2022]

References

1. Poland pubmed.ncbi.nlm.nih.gov

Quality of care of hospitalised patients with heart failure in Poland in 2013: results of the second nationwide survey. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

Endpoint prediction of heart failure using electronic health records. [2021]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Clinical Pharmacist's Intervention to Improve Medication Titration for Heart Failure: First Experience from Sudan. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Impact of a Telemedicine Program After a Heart Failure Hospitalization on 12 Months Follow-Up Events. [2023]

5. Portugal pubmed.ncbi.nlm.nih.gov

Expert perspectives on strategic factors for the management and prevention of heart failure in Portugal. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Characterization and prediction of adverse events from intensive chronic heart failure management and effect on quality of life: results from the pro-B-type natriuretic peptide outpatient-tailored chronic heart failure therapy (PROTECT) study. [2015]

7. England pubmed.ncbi.nlm.nih.gov

Evolving therapies for the management of chronic and acute decompensated heart failure. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Perceived adverse drug events in heart failure: patients' perception and related factors. [2011]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Adverse drug reaction-related hospitalisations among patients with heart failure at two hospitals in the United Arab Emirates. [2022]

10. Canada pubmed.ncbi.nlm.nih.gov

Adverse drug events and associated factors in heart failure therapy among the very elderly. [2021]

11. Italy pubmed.ncbi.nlm.nih.gov

[Integrated social and health care supported by home telemonitoring in patients with heart failure: the European SmartCare project in the Friuli Venezia Giulia Region]. [2021]

12. Argentina pubmed.ncbi.nlm.nih.gov

[Telemonitoring and a real-time alert system in heart failure: a preliminary pilot study of feasibility, acceptability and efficacy]. [2023]

13. Canada pubmed.ncbi.nlm.nih.gov

Passively Captured Interpersonal Social Interactions and Motion From Smartphones for Predicting Decompensation in Heart Failure: Observational Cohort Study. [2022]

14. Canada pubmed.ncbi.nlm.nih.gov

Smartphone Ownership and Interest in Mobile Health Technologies for Self-care Among Patients With Chronic Heart Failure: Cross-sectional Survey Study. [2022]

15. Ireland pubmed.ncbi.nlm.nih.gov

Healthcare providers' perspectives on using smart home systems to improve self-management and care in people with heart failure: A qualitative study. [2022]