Virtual Cardiology Program for Heart Failure

(ELEVATE-HF Trial)

Recruiting at 2 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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate how safe and effective a remote, virtual, cardiology program is that provides heart failure education to patients, monitors for worsening heart failure, and quickly adjusts heart failure medications, compared to usual care medication use and adjustment, in participants with decompensated heart failure that are recently hospitalized.

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 data supports the effectiveness of the Virtual Cardiology Program for Heart Failure treatment?

Research shows that remote patient management and telemonitoring can help detect early signs of heart failure, allowing for timely treatment and reducing hospital readmissions. Virtual appointments also empower patients by providing education and feedback, which can improve their health outcomes. ^{1 2 3 4 5}

Is the Virtual Cardiology Program for Heart Failure safe for humans?

The Virtual Cardiology Program, also known as telecardiology, has been used safely in patients with chronic heart failure. In a study, patients experienced some minor issues like asymptomatic hypotension (low blood pressure without symptoms), but overall, the program was managed safely with no major safety concerns reported. ^{2 6 7 8 9}

How is the Virtual Cardiology Program for Heart Failure different from other treatments?

The Virtual Cardiology Program for Heart Failure is unique because it uses remote monitoring and virtual appointments to manage heart failure, allowing for early detection of issues and personalized care without needing frequent hospital visits. This approach empowers patients by providing education and feedback, and helps address noncompliance, which can improve outcomes. ^{1 2 4 7 10}

Research Team

Adam DeVore

Principal Investigator

Duke University

Eligibility Criteria

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.

I am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

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]

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 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]

References

1. Singapore pubmed.ncbi.nlm.nih.gov

Home Telemedicine in Heart Failure: A Pilot Study of Integrated Telemonitoring and Virtual Provider Appointments. [2022]

2. England pubmed.ncbi.nlm.nih.gov

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

3. England pubmed.ncbi.nlm.nih.gov

Telemonitoring or structured telephone support programmes for patients with chronic heart failure: systematic review and meta-analysis. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Tele-guidance of chronic heart failure patients enhances knowledge about the disease. A multi-centre, randomised controlled study. [2011]

5. Germany pubmed.ncbi.nlm.nih.gov

Continuous Remote Patient Monitoring: Evaluation of the Heart Failure Cascade Soft Launch. [2022]

6. Canada pubmed.ncbi.nlm.nih.gov

A Virtual Cardiovascular Care Program for Prevention of Heart Failure Readmissions in a Skilled Nursing Facility Population: Retrospective Analysis. [2021]

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

A multi-layer monitoring system for clinical management of Congestive Heart Failure. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Telecardiology: one-lead electrocardiogram monitoring and nurse triage in chronic heart failure. [2005]

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

Exploring patient experiences and perspectives of a heart failure telerehabilitation program: A mixed methods approach. [2018]

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

Management of Frail and Older Homebound Patients With Heart Failure: A Contemporary Virtual Ambulatory Model. [2022]