Virtual Care for Heart Failure

(VICTORY-HF Trial)

Recruiting at 8 trial locations

Overseen By VICTORY-HF Project office

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Population Health Research Institute

Disqualifiers: Severe lung disease, Severe kidney disease, Active malignancy, others

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

Compensation: Varies

Number of Visits: 90

Duration: 90 days

891 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of virtual care for people with heart failure. It compares traditional in-person heart failure care with a digital approach to determine if virtual support can improve health outcomes over six months. The trial seeks participants who have recently been hospitalized for heart failure and meet specific heart function and blood marker criteria. Individuals recently discharged from a hospital stay for heart failure may find this trial suitable. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance future heart failure care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this virtual care method is safe for heart failure patients?

Research has shown that virtual care for heart failure is safe. One study found that a virtual care team managing treatments was well-received and did not cause serious side effects. This approach also helped patients manage their medications more effectively in various hospitals.

Another study on virtual home health programs for heart failure reported positive results. Patients in these programs had fewer hospital visits and managed their health better at home.

These findings suggest that virtual care for heart failure is a safe and effective way to support patients without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about virtual care for heart failure because it offers a new way to manage the condition remotely. Unlike traditional in-person visits, virtual heart failure care allows patients to optimize their medical therapies from the comfort of their own homes. This approach can lead to more frequent monitoring and quicker adjustments in treatment, potentially improving patient outcomes. Additionally, virtual care could make managing heart failure more accessible for people who have difficulty traveling to appointments, giving them the support they need without the hassle of frequent clinic visits.

What evidence suggests that virtual HF care is effective for heart failure?

This trial will compare Virtual HF Care with Routine HF Care. Research has shown that virtual care for heart failure can enhance treatment. Studies have found that a virtual care team adjusting heart failure medications leads to better outcomes, such as improved heart function and overall health. Participants receiving Virtual HF Care in this trial may manage their heart failure medications more safely and effectively. This approach ensures patients receive the correct medication dosage at the right time, improving their condition. ^{1 2 3 4 6}

Who Is on the Research Team?

Harriette Van Spall, MD

Principal Investigator

McMaster University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with heart failure, recently hospitalized or seen urgently for the condition. Participants must have NT-proBNP >900 pg/ml and LVEF <55% within the last 3 months. They should be able to use virtual care tools (with help if needed) and provide a mailing address.

Inclusion Criteria

provide consent.

have a mailing address for the patient or caregiver

are competent (either independently or with caregiver) in using the virtual care platform during a brief demonstration

Timeline for a Trial Participant

Pilot Phase

Pilot phase conducted to assess the acceptability and feasibility of the intervention, refine the virtual delivery process, and finalize protocols

Not specified

Treatment

Participants receive virtual HF care to optimize medical therapies

90 days

Number of virtual and in-person clinic visits per patient in 90 days

Follow-up

Participants are monitored for primary medication and health status outcomes

90 days

Extended Follow-up

Co-primary clinical outcomes obtained, including all-cause death, HF hospitalization, and ED visits

180 days

What Are the Treatments Tested in This Trial?

Interventions

• Routine HF Care
• Virtual HF Care

Trial Overview The study compares two types of post-hospitalization heart failure care: Virtual HF Care versus Routine HF Care. It examines how these approaches affect medication adherence and health status over a follow-up period of 90 days, with clinical outcomes assessed at 180 days.

How Is the Trial Designed?

Group I: Virtual HF care Experimental Treatment 1 Intervention

Patients will receive virtual HF care to optimize medical therapies

Group II: Routine HF care Experimental Treatment 1 Intervention

Participants will receive routine HF care

Who Is Running the Clinical Trial?

Population Health Research Institute

Lead Sponsor

Trials

165

Recruited

717,000+

Hamilton Health Sciences Corporation

Collaborator

Trials

380

Recruited

345,000+

McMaster University

Collaborator

Trials

936

Recruited

2,630,000+

Published Research Related to This Trial

Digital health interventions (DHI) significantly reduced all-cause mortality (8.5% vs. 10.2%) and cardiovascular mortality (7.3% vs. 9.6%) in patients with a history of heart failure hospitalization, based on a review of 10 trials involving 7204 patients over an average follow-up of 15.6 months.

While DHI did not significantly decrease overall hospitalizations for heart failure or all causes, patients using DHI experienced fewer days lost due to heart failure-related hospitalizations, indicating a potential benefit in managing heart failure symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital health intervention in patients with recent hospitalization for acute heart failure: A systematic review and meta-analysis of randomized trials. Elbadawi, A., Tan, BE., Assaf, Y., et al.[2022]

A digital solution called SK-141 was found to be highly acceptable among heart failure patients, with an 80% retention rate over an 8-week study involving 20 participants, indicating strong patient engagement.

Clinical outcomes showed promising trends towards improvement, suggesting that remote monitoring and self-care support could enhance the quality of life for heart failure patients, warranting further research in a larger, controlled study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving outpatient care for heart failure through digital innovation: a feasibility study. Arnar, DO., Oddsson, SJ., Gunnarsdottir, T., et al.[2022]

Mobile technologies for post-discharge care in heart failure patients can significantly improve remote patient management, particularly in reducing rehospitalization rates, as shown in a review of 171 studies.

The most effective interventions focus on patient self-care and managing all-cause hospital visits, with integrated remote patient management solutions demonstrating the best outcomes in decreasing readmission rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual healthcare solutions in heart failure: a literature review. Lee, KC., Breznen, B., Ukhova, A., et al.[2023]

In the TIM-HF2 trial involving 1,538 heart failure patients, remote patient management (RPM) showed a significant reduction in all-cause mortality for patients with an estimated glomerular filtration rate (eGFR) less than 60 ml/min/1.73 m², with a 1-year survival rate of 89.4% compared to 84.6% in usual care (UC).

RPM also led to lower rates of heart failure hospitalizations and all-cause death in both eGFR subgroups, indicating its potential effectiveness in managing heart failure, particularly in patients with compromised kidney function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote Patient Management May Reduce All-Cause Mortality in Patients With Heart-Failure and Renal Impairment. Naik, MG., Budde, K., Koehler, K., et al.[2022]

A study involving 49 homebound, frail, and older patients with heart failure showed that nurse-assisted virtual video visits significantly reduced hospitalization rates and days compared to the previous year, indicating improved management of heart failure in this population.

The model demonstrated a decrease in emergency department visits, suggesting that virtual care can effectively address the barriers faced by older patients in accessing specialized cardiac care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of Frail and Older Homebound Patients With Heart Failure: A Contemporary Virtual Ambulatory Model. Kobulnik, J., Wang, IY., Bell, C., et al.[2022]

Remote patient management (RPM) significantly improved heart failure-specific self-care behaviors in patients, with an increase in self-care scores from 78.7 to 84.5 in the RPM group compared to a smaller increase in the usual care group, indicating better adherence to heart failure regimens.

The most notable improvements in self-care were observed in patients living alone and those with initially low self-care scores, suggesting that RPM can be particularly beneficial for vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of remote patient management on self-care behaviour in heart failure patients: results from the randomized TIM-HF2 trial. Deckwart, O., Koehler, K., Lezius, S., et al.[2023]

In a survey of 125 heart failure patients, over half (52%) expressed disinterest in using digital health solutions for follow-up, highlighting challenges in implementing digital patient-reported outcome measures (PROMs) in this population.

Among those willing to use digital solutions, a web-based option was preferred by 70%, indicating a potential direction for future digital health interventions, especially considering that older patients were less likely to engage with digital tools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' preferences regarding the digital capturing of patient-reported outcomes: planning the future follow-up in a prospective heart failure registry. König, S., Leiner, J., Nitsche, A., et al.[2023]

A pilot study involving 28 heart failure patients tested a web-based self-care intervention, showing small improvements in self-care (d=0.32) and self-efficacy (d=0.37) after one month, but minimal change in heart failure knowledge (d=0.06).

Despite the intervention's potential, only 50% of participants accessed the web platform daily, indicating challenges in engagement that need to be addressed in larger trials to enhance patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating a Web-Based Self-Management Intervention in Heart Failure Patients: A Pilot Study. Bashi, N., Windsor, C., Douglas, C.[2020]

The LEAP Virtual Visit protocol for heart failure patients outlines a structured approach to virtual healthcare, detailing specific steps, roles, and tools needed for effective implementation, which can enhance patient care.

This protocol includes comprehensive support materials for both clinicians and patients, aiming to improve satisfaction and streamline the virtual visit process, potentially benefiting the overall healthcare system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

LEAP Virtual Visit Assessment (VIVA): a structured protocol for virtual visits for patients with heart failure. Gori, M., Bonmassari, R., Correale, M., et al.[2022]

Heart failure (HF) is becoming increasingly prevalent, especially among older adults, and the current treatment methods are not effectively tailored to individual patient needs, highlighting the need for a new approach.

The proposed solution involves a predictive, preventive, and personalized medicine strategy using an AI-driven online application that empowers patients to manage their own care, potentially improving outcomes and reducing healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Artificial intelligence supported patient self-care in chronic heart failure: a paradigm shift from reactive to predictive, preventive and personalised care. Barrett, M., Boyne, J., Brandts, J., et al.[2020]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40473009/

Rationale, design, and baseline characteristics of the ... The VITAL-HF (Virtual Care to Improve Heart Failure Outcomes) trial assessed the safety and efficacy of a remote, digital intervention targeting GDMT ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05602454

Virtual Care to Improve Heart Failure Outcomes (VITAL-HF) The purpose of this study is to evaluate how safe and effective a remote, digital intervention is that helps clinicians use and optimally adjust heart failure ...

3. cardio.jmir.org cardio.jmir.org/2025/1/e64877

Evaluation of a Virtual Home Health Heart Failure Program Understanding the outcomes and experience of remote monitoring–enabled interdisciplinary chronic disease management programs can inform resource ...

4. jacc.org jacc.org/doi/10.1016/j.jacc.2023.02.029

Virtual Care Team Guided Management of Patients With ... A virtual care team guided strategy for GDMT optimization was safe and improved GDMT across multiple hospitals in an integrated health system.

5. sciencedirect.com sciencedirect.com/science/article/pii/S1071916424005529

115 Effectiveness Of A Virtual Guideline Directed Medical ... Many studies have shown that heart failure (HF) patients who are promptly titrated on guideline-directed medical therapy (GDMT) experience improved outcomes.

6. sciencedirect.com sciencedirect.com/science/article/pii/S0147956324000049

Telehealth care and remote monitoring strategies in heart ... This meta-analysis provides insights about telemonitoring on heart failure patients. Telemonitoring reduces mortality and rehospitalization in hearth failure ...