Virtual Cardiology Program for Heart Failure

(ELEVATE-HF Trial)

Recruiting at 5 trial locations

Overseen By Project Manager

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Must not be taking: Intravenous inotropes

Disqualifiers: Pregnancy, Dialysis, Heart transplant, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 120 days

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a virtual cardiology program can safely and effectively assist people with heart failure who were recently hospitalized. It compares the virtual program, which includes remote monitoring and medication adjustments by cardiologists, to the usual care patients receive. The trial seeks participants who have been hospitalized due to sudden worsening heart failure symptoms and are comfortable using technology to track their health. As an unphased trial, this study provides patients the opportunity to contribute to innovative research that could enhance future heart failure care.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications. However, it involves adjusting heart failure medications, so you might need to change how you take them.

What prior data suggests that this virtual cardiology program is safe for heart failure patients?

Research has shown that virtual heart care programs are generally safe for people with heart failure. One study found that these remote health programs can help manage heart failure without causing additional harm. Another study demonstrated that telemonitoring, or checking health data from a distance, can reduce the risk of death and hospital visits for heart failure patients, indicating these programs are well-received.

Patients who have used similar virtual programs reported no major safety issues. Most felt comfortable with the technology and had positive experiences.

Despite providing care remotely, these programs closely monitor important health signs. This careful monitoring can catch problems early, enhancing treatment safety. Overall, existing studies suggest that virtual heart care programs are safe and may improve health outcomes for people with heart failure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Virtual Cardiology Program for heart failure because it leverages remote monitoring technology to gather real-time health data from patients at home. Unlike traditional heart failure care, which typically involves periodic in-person visits, this program uses devices like a blood pressure cuff, scale, Pulse Ox, and EKG Single-Lead monitor to continuously monitor vital signs and heart activity. This data is then analyzed by a team of cardiologists who can adjust medications and make clinical decisions more promptly. This approach has the potential to provide more personalized care and improve outcomes by intervening faster when changes in a patient's condition are detected.

What evidence suggests that this virtual cardiology program is effective for heart failure?

Research has shown that virtual heart care programs, such as the Virtual Cardiology Program tested in this trial, can effectively manage heart failure. Participants may receive quick medication adjustments through remote check-ups, which studies have found often lead to better outcomes. For instance, virtual visits can reduce hospital and emergency room visits. Additionally, early monitoring of symptoms, such as weight changes, helps identify issues early. Overall, virtual care for heart failure appears promising and can improve health by enabling timely medical decisions. ^{3 4 6 7 8}

Who Is on the Research Team?

Adam DeVore

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for patients recently hospitalized with acute decompensated heart failure. It's designed to help those who could benefit from a virtual cardiology program that educates and monitors them, adjusting their medications as needed.

Inclusion Criteria

Fluent in written and spoken English

I was hospitalized primarily due to worsening heart failure symptoms.

Exclusion Criteria

I have had a heart transplant or am on the waiting list for one.

I regularly use IV medications like milrinone, dobutamine, or dopamine.

Current pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a remote, virtual cardiology program that provides heart failure education, monitors vital signs, and adjusts medications

120 days

Remote monitoring with daily data transmission

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Cardiology Program

Trial Overview The study tests the safety and effectiveness of a remote virtual cardiology program against standard care. The program provides education, monitors symptoms, and adjusts heart failure medications remotely.

How Is the Trial Designed?

Group I: Experimental: Remote Virtual Cardiology Program Experimental Treatment 1 Intervention

The Ventricle Health program will remotely receive daily vital signs directly from a blood pressure cuff and scale provided to the participant. In addition, the program will also remotely receive oxygen levels and electrical heart activity directly from a Pulse Ox and an EKG Single-Lead monitor, provided to the participant. All of this data will be transmitted to the Ventricle Health program. The Ventricle Health team, consisting of Cardiologists and clinical staff, will use this data to titrate medications and make clinical decisions.

Group II: Usual Care Active Control 1 Intervention

Routine clinical care will be followed. Participants should be recommended for the best possible outpatient heart failure care at each site.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Ventricle Health

Collaborator

Trials

1

Recruited

180+

Published Research Related to This Trial

The TIM-HF2 trial, involving 1571 heart failure patients, demonstrated that remote patient management significantly reduced the percentage of days lost due to unplanned cardiovascular hospital admissions and all-cause death compared to usual care, with a reduction from 6.64% to 4.88%.

Patients receiving remote management had a lower all-cause death rate of 7.86 per 100 person-years compared to 11.34 per 100 person-years in the usual care group, indicating that this intervention may enhance patient outcomes in heart failure management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of telemedical interventional management in patients with heart failure (TIM-HF2): a randomised, controlled, parallel-group, unmasked trial. Koehler, F., Koehler, K., Deckwart, O., et al.[2022]

Remote monitoring programs for chronic heart failure, including structured telephone support and telemonitoring, significantly reduced hospital admissions by 21% and all-cause mortality by 20% in a review of 14 trials involving 4264 patients.

Three out of six studies reported improvements in health-related quality of life with remote monitoring, and three out of four studies on healthcare costs indicated reduced expenses, highlighting the overall benefits of these programs for patients in the community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemonitoring or structured telephone support programmes for patients with chronic heart failure: systematic review and meta-analysis. Clark, RA., Inglis, SC., McAlister, FA., et al.[2022]

A home-based telecardiology intervention for 230 patients with chronic heart failure showed that telemonitoring and ECG monitoring can effectively manage patient care, with 3767 calls made over 12 months, leading to significant clinical actions such as therapy changes and hospital admissions.

The use of one-lead ECG recordings allowed for better management of beta-blocker dosages in patients, indicating that this method provides additional benefits beyond standard telephone follow-up in monitoring heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telecardiology: one-lead electrocardiogram monitoring and nurse triage in chronic heart failure. Scalvini, S., Martinelli, G., Baratti, D., et al.[2005]

The proposed remote monitoring system for Congestive Heart Failure (CHF) patients effectively utilizes a Decision Support System (DSS) with machine learning to predict decompensations and assess heart failure severity, achieving an accuracy of 71.9% and 81.3%, respectively.

The system's custom-designed sensors for home monitoring provide reliable data comparable to established literature, supporting the use of heart rate variability (HRV) as a promising method for distinguishing between healthy individuals and CHF patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multi-layer monitoring system for clinical management of Congestive Heart Failure. Guidi, G., Pollonini, L., Dacso, CC., et al.[2018]

Patients with heart failure who participated in a 12-week group-based telerehabilitation program reported high satisfaction with the visual clarity and ease of use of the technology, indicating that this method is a viable option for delivering care.

While participants appreciated the health benefits and social support from the program, they suggested improvements in audio clarity, connectivity, and computer training, and many preferred a hybrid model that combines both online and face-to-face interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring patient experiences and perspectives of a heart failure telerehabilitation program: A mixed methods approach. Hwang, R., Mandrusiak, A., Morris, NR., et al.[2018]

A randomized trial involving 214 chronic heart failure patients showed that a remote guidance system using a home TV-channel for education did not significantly reduce hospital admissions or improve quality of life compared to standard care.

However, patients using the tele-guidance system had a significantly greater increase in their knowledge about heart failure, suggesting that this approach may enhance patient education and self-management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tele-guidance of chronic heart failure patients enhances knowledge about the disease. A multi-centre, randomised controlled study. Balk, AH., Davidse, W., Dommelen, Pv., et al.[2011]

The continuous remote patient monitoring (CRPM) system, utilizing wearable biosensors and machine learning algorithms, shows promise in managing heart failure patients post-discharge by potentially reducing readmissions through early intervention protocols.

During a soft launch involving five patients, the study identified areas for improvement in communication and protocol adherence, highlighting the need for further education and engagement of healthcare workers to effectively implement this technology in patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous Remote Patient Monitoring: Evaluation of the Heart Failure Cascade Soft Launch. Chi, WN., Reamer, C., Gordon, R., et al.[2022]

A virtual cardiovascular care program significantly reduced the 30-day hospital readmission rates for heart failure patients in skilled nursing facilities, with readmission rates of 3% compared to an expected 10%.

Out of 3510 patients, only 185 received virtual care, but those who did showed a notable decrease in all-cause readmissions (18% vs expected 27%), suggesting that virtual consultations can be an effective intervention for high-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Virtual Cardiovascular Care Program for Prevention of Heart Failure Readmissions in a Skilled Nursing Facility Population: Retrospective Analysis. Friedman, DM., Goldberg, JM., Molinsky, RL., et al.[2021]

The Health Connect system, which combines telemonitoring of physiological data with regular virtual provider appointments, aims to reduce hospital readmission rates for patients with congestive heart failure.

This system not only helps in early identification of health issues but also empowers patients through education and feedback, addressing noncompliance that often leads to poor health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home Telemedicine in Heart Failure: A Pilot Study of Integrated Telemonitoring and Virtual Provider Appointments. Idris, S., Degheim, G., Ghalayini, W., 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]

Citations

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Evaluation of a Virtual Home Health Heart Failure Program This study contributes to the understanding of how remote patient monitoring with interdisciplinary chronic disease support, integrated into an ...

2. 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 ...

3. jacc.org jacc.org/doi/10.1016/j.jacc.2023.04.010

Remote Monitoring for Heart Failure Management at Home Early telemonitoring of weights and symptoms did not decrease heart failure hospitalizations but helped identify steps toward effective monitoring programs.

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An Overview of Telehealth in the Management ... Telehealth has been used to facilitate the management of many CVDs, such as arrhythmia detection, heart failure, hypertension, coronary artery ...

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Virtual visits in cardiovascular disease: a rapid review of the ... Virtual visits are non-inferior, or more effective, in reducing hospitalizations and visits to emergency departments in patients with CVD.

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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 ...

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Evaluation of a Virtual Home Health Heart Failure Program A mixed methods study was conducted with patients and HCPs. Self-reported outcome data (KCCQ-12 [Kansas City Cardiomyopathy Questionnaire-12], ...

8. 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 ...