Virtual Cardiology Program for Heart Failure

(ELEVATE-HF Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Adam DeVore

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Duke University

Must not be taking: Intravenous inotropes

Disqualifiers: Pregnancy, Dialysis, Heart transplant, others

No Placebo Group

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}

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

Trial 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 (Behavioural Intervention)

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Duke University Medical Center Durham, NC

Duke Raleigh Hospital Raleigh, NC

Who Is Running the Clinical Trial?

Duke University Lead Sponsor

Ventricle Health Collaborator

References

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

Home Telemedicine in Heart Failure: A Pilot Study of Integrated Telemonitoring and Virtual Provider Appointments. [2022] Congestive heart failure is a significant cause of hospitalization, rehospitalization, and death. Reducing hospital readmission rates is a national priority. Various telemonitoring devices and programs have been developed to help meet this goal. The Health Connect system incorporates monitoring of physiologic data with regular virtual provider appointments. The Health Connect system integrates traditional telemedicine with virtual provider appointments. Virtual appointments empower patients to advocate for their own health by providing numerous opportunities for education and feedback. In addition to early identification of impending decompensation, virtual appointments allow providers to address noncompliance, which is a major factor driving poor outcomes. Further research is required to confirm the benefit of the Health Connect system.

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] Remote patient management in patients with heart failure might help to detect early signs and symptoms of cardiac decompensation, thus enabling a prompt initiation of the appropriate treatment and care before a full manifestation of a heart failure decompensation. We aimed to investigate the efficacy of our remote patient management intervention on mortality and morbidity in a well defined heart failure population.

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] To determine whether remote monitoring (structured telephone support or telemonitoring) without regular clinic or home visits improves outcomes for patients with chronic heart failure.

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] New strategies are required to optimize care in increasing numbers of chronic heart failure patients. The aim of this randomised trial was to evaluate a remote guidance system.

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

Continuous Remote Patient Monitoring: Evaluation of the Heart Failure Cascade Soft Launch. [2022] We report on our experience of deploying a continuous remote patient monitoring (CRPM) study soft launch with structured cascading and escalation pathways on heart failure (HF) patients post-discharge. The lessons learned from the soft launch are used to modify and fine-tune the workflow process and study protocol.

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] Patients with heart failure (HF) in skilled nursing facilities (SNFs) have 30-day hospital readmission rates as high as 43%. A virtual cardiovascular care program, consisting of patient selection, initial televisit, postconsultation care planning, and follow-up televisits, was developed and delivered by Heartbeat Health, Inc., a cardiovascular digital health company, to 11 SNFs (3510 beds) in New York. The impact of this program on the expected SNF 30-day HF readmission rate is unknown, particularly in the COVID-19 era.

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

A multi-layer monitoring system for clinical management of Congestive Heart Failure. [2018] Congestive Heart Failure (CHF) is a serious cardiac condition that brings high risks of urgent hospitalization and death. Remote monitoring systems are well-suited to managing patients suffering from CHF, and can reduce deaths and re-hospitalizations, as shown by the literature, including multiple systematic reviews.

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

Telecardiology: one-lead electrocardiogram monitoring and nurse triage in chronic heart failure. [2005] We investigated a home-based intervention based on telecardiology in patients with chronic heart failure (CHF). Two hundred and thirty CHF patients, aged 59 years (SD 9), in stable condition and with optimized therapy were enrolled. The programme consisted of trans-telephonic follow-up and electrocardiogram (ECG) monitoring followed by visits from a paramedical and medical team. The patient could call the centre when required (tele-assistance), while the team could call the patient at prescheduled times (telemonitoring). During the first 12 months, there were 3767 calls (873 ad hoc and 2894 scheduled calls). There were 648 events, including 126 episodes of asymptomatic hypotension and 168 episodes which were not due to cardiological symptoms. No actions were taken by the nurse after 2417 calls (64%). A change in therapy was suggested after 418 calls, hospital admission in 62 patients, further investigations for 243 patients and a consultation with the general practitioner in 41 patients. A total of 2303 one-lead ECG recordings were received (10 per patient); 126 recordings (6%) were diagnosed as pathological in comparison with the baseline one. The one-lead ECG recording was used for titration of beta-blockers in 79 patients (mean dosage 38 mg vs 42 mg, P

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

Exploring patient experiences and perspectives of a heart failure telerehabilitation program: A mixed methods approach. [2018] To describe patient experiences and perspectives of a group-based heart failure (HF) telerehabilitation program delivered to the homes via online video-conferencing.

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

Management of Frail and Older Homebound Patients With Heart Failure: A Contemporary Virtual Ambulatory Model. [2022] Heart failure (HF) affects many patients who are older and frail, presenting multiple physical barriers to accessing specialty care in a traditional ambulatory clinic model. Here, we present an assisted virtual care model in which a home visiting nurse facilitated video visits with a HF cardiologist to follow homebound, frail, and older patients with HF.