COMPASSION Digital Biomarker for Heart Failure

(COMPASSION Trial)

Overseen By Navin Govind

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Aventyn, Inc.

Disqualifiers: Unreliable for follow-up, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

1000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for monitoring heart failure using digital tools. It aims to assist individuals with heart failure, a condition that hinders the heart's ability to pump blood effectively, causing symptoms such as shortness of breath and fatigue. The trial will evaluate the effectiveness of these digital monitors in two groups: those hospitalized with heart failure or a heart attack, and those over 50 with COVID-19 and another risk factor. Suitable candidates have been hospitalized for heart failure or a heart attack and experience symptoms like chest pain or shortness of breath. Participants will use digital devices to track their health daily for 30 days after hospital discharge. As an unphased trial, this study provides a unique opportunity to contribute to innovative heart failure monitoring solutions.

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 the COMPASSION Digital Biomarker is safe for heart failure patients?

Research shows that the COMPASSION Digital Biomarker is under study to help manage heart failure and heart attacks. Although specific safety data for humans is not yet available, some assumptions can be made based on the study type.

This trial is labeled as "Not Applicable" in terms of phases, indicating a focus on gathering information to support future research rather than testing a new drug or treatment. This suggests specific safety data might not be available yet.

However, since the study involves digital monitoring of vital signs like blood pressure and heart rate, it is likely non-invasive and poses minimal risk. Digital tools often have fewer side effects compared to traditional treatments because they don't involve medication or surgery.

Overall, while concrete safety data for the COMPASSION Digital Biomarker is not available, its role as a digital monitoring tool suggests it is likely well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the COMPASSION Digital Biomarker for heart failure because it leverages cutting-edge remote monitoring technology to track patients' vital signs daily. Unlike traditional treatments that focus primarily on medication and in-hospital care, this approach uses a biomarker-based algorithm to predict and prevent heart failure complications at home. The real-time data collection empowers healthcare teams to make timely interventions, potentially reducing hospital readmissions and improving patient outcomes.

What evidence suggests that the COMPASSION Digital Biomarker is effective for heart failure?

Research has shown that digital tools can help manage heart failure by tracking important health signs like blood pressure and heart rate. In this trial, participants will use the COMPASSION Digital Biomarker to monitor these vital signs. Studies have found that using such tools can lead to better outcomes, such as fewer hospital visits and lower death rates for heart failure patients. Specifically, one study found that monitoring these signs helped doctors intervene earlier and more effectively when patients' conditions worsened. This method is especially helpful for patients with serious heart problems, making it easier to adjust treatments and improve their quality of life. Overall, early evidence suggests that digital tools could be a promising way to manage heart failure symptoms and reduce hospital readmissions. ^{2 3 4 6 7}

Who Is on the Research Team?

Zaki Lababidi, MD

Principal Investigator

Gilbert Cardiology

Ashok Solsi, MD

Principal Investigator

Premier Cardiovascular Center

Kris Vijay, MD

Principal Investigator

Abrazo Arizona Heart

Raj Bhat, MD

Principal Investigator

Pioneer Hospitalists

Are You a Good Fit for This Trial?

This trial is for men and women over 18 who are hospitalized with acute decompensated heart failure (ADHF) or a recent heart attack (acute myocardial infarction). They must show symptoms like shortness of breath, fatigue, signs of fluid in the lungs, high levels of certain heart-related biomarkers, or reduced heart function.

Inclusion Criteria

I am over 18 years old.

I have heart failure confirmed by symptoms, tests showing lung congestion, or high BNP/NT-proBNP levels.

I am hospitalized with acute heart failure or a recent heart attack.

Exclusion Criteria

Study informed consent will be obtained before enrollment in the study for Phase 1 and Phase 2

For phase 2, subjects should be able to be randomized within 48 hours of Covid19 antigen positive status

Patients considered unreliable by the investigator concerning the requirements for follow-up visits

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants measure their vitals daily for 30 days after discharge, with remote monitoring by the H2O care team and hospitalist to prevent readmissions.

4 weeks

Daily remote monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on reducing readmissions and improving well-being.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• COMPASSION Digital Biomarker

Trial Overview The study is testing the COMPASSION Digital Biomarker to see if it can help improve outcomes for patients readmitted to the hospital due to heart failure or after a recent heart attack. The goal is to better coordinate care and possibly reduce future hospital visits.

How Is the Trial Designed?

Group I: Subjects Testing Positive Covid-19 Antigen Test Experimental Treatment 1 Intervention

Phase 2 subjects 50 years or older with positive Covid-19 antigen test and one other risk factor as mentioned in the comorbid section of workflow will be enrolled in this arm of the study. Subjects will be randomized within 48 hours of Covid-19 antigen positive status. Patients will measure their vitals Weight, Sitting BP, Fluid Status, Heart Rate, Respiration Rate each morning for 30 days after discharge. The monitoring of this data of each patient daily will be done by dedicated H2O care team and hospitalist. The hospitalist will coordinate with the patient, the home health team, SNFs and the cardiologists as needed to correct/treat any major abnormalities picked up by the remote monitoring system in order to prevent readmissions. Vitals data collected by the Vitalbeat workbench for biomarker based algorithm variables will be used to drive intervention based on PAP systolic and diastolic pressures.

Group II: Subjects Hospitalized with a Primary Diagnosis of ADHF or Acute MI Experimental Treatment 1 Intervention

Phase 1 subjects 18 years or above hospitalized with a primary diagnosis of ADHF or acute MI. Patients will measure their vitals Weight, Sitting BP, Fluid Status, Heart Rate, Respiration Rate each morning for 30 days after discharge. The monitoring of this data of each patient daily will be done by dedicated H2O care team and hospitalist. The hospitalist will coordinate with the patient, the home health team, SNFs and the cardiologists as needed to correct/treat any major abnormalities picked up by the remote monitoring system in order to prevent readmissions. Vitals data collected by the Vitalbeat workbench for biomarker based algorithm variables will be used to drive intervention based on PAP systolic and diastolic pressures.

Who Is Running the Clinical Trial?

Aventyn, Inc.

Lead Sponsor

Trials

5

Recruited

28,100+

TwinEpidemic

Collaborator

Trials

1

Recruited

1,000+

Arizona State University

Collaborator

Trials

311

Recruited

109,000+

Intel Corporation

Industry Sponsor

Trials

10

Recruited

28,800+

Heart Health Organization East Valley

Collaborator

Trials

1

Recruited

1,000+

Published Research Related to This Trial

A personalized follow-up procedure for heart failure (HF) patients significantly reduced readmission rates by 19.8% and emergency department visits by 44%, indicating improved patient management.

The intervention not only enhanced patient outcomes, with 31% of patients showing improved functional class, but also resulted in substantial cost savings of €72,769 per patient, highlighting the economic benefits of personalized care in managing HF.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomarkers-based personalized follow-up in chronic heart failure improves patient's outcomes and reduces care associate cost. Leon-Justel, A., Morgado Garcia-Polavieja, JI., Alvarez-Rios, AI., et al.[2021]

Natriuretic peptides, particularly BNP and N-terminal proBNP, are established as the gold standard biomarkers for diagnosing and managing heart failure (HF), indicating their critical role in patient evaluation.

Emerging biomarkers reflecting various pathophysiological processes in HF show promise for enhancing patient management, particularly in identifying early renal dysfunction, but further studies are needed to fully validate their clinical utility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ANMCO/ELAS/SIBioC Consensus Document: biomarkers in heart failure. Aspromonte, N., Gulizia, MM., Clerico, A., et al.[2023]

Natriuretic peptides, specifically BNP and N-terminal proBNP, are established as the gold standard biomarkers for diagnosing and managing heart failure (HF), indicating their critical role in patient evaluation.

Emerging biomarkers reflecting various pathophysiological processes in HF, such as inflammation and fibrosis, show promise for enhancing patient management, but further studies are needed to fully validate their clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[ANMCO/ELAS/SIBioC Consensus document: Recommendations for the use of cardiac biomarkers in heart failure patients]. Aspromonte, N., Gulizia, MM., Clerico, A., et al.[2017]

Biomarkers are crucial for diagnosing heart failure, as they can indicate various biological processes and responses to treatment, but their effectiveness depends on factors like sensitivity, specificity, and patient preferences.

Research is ongoing to identify and validate a range of biomarkers related to heart failure, including those linked to inflammation and oxidative stress, with the potential for combining multiple biomarkers to improve diagnostic accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomarkers in heart failure. Eleuteri, E., Di Stefano, A.[2015]

Recent advancements in highly sensitive immunoassays for measuring troponin levels in the blood are enhancing the clinical assessment of patients with chronic heart failure.

Even small amounts of circulating cardiac contractile proteins, like troponin, can provide valuable insights into the severity and management of heart failure, improving diagnostic accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Significance of measurable cardiac troponin by high-sensitivity assays in patients with chronic stable heart failure. Latini, R., Masson, S.[2015]

The Patient Generated Index (PGI) is a useful tool for assessing quality of life in older heart failure patients, allowing them to express their individual needs and preferences, although its reproducibility and responsiveness are not as high as other established questionnaires.

Physical function, particularly walking and performing daily activities, is the most significant factor affecting quality of life for older patients with chronic heart failure, as identified through the PGI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using an individualised quality of life measure in older heart failure patients. Witham, MD., Crighton, LJ., McMurdo, ME.[2019]

The Heart Failure Academic Research Consortium aims to enhance heart failure clinical research by standardizing measures of functional and quality-of-life endpoints, which can improve patient outcomes and survival.

While patient-reported outcomes and exercise tolerance assessments are validated for use in trials, the use of actigraphy as a measurement tool remains inconsistent, highlighting the need for further standardization in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional and Symptomatic Clinical Trial Endpoints: The HFC-ARC Scientific Expert Panel. Psotka, MA., Abraham, WT., Fiuzat, M., et al.[2023]

Brain natriuretic peptide (BNP) is currently the gold standard for managing heart failure (HF), but novel biomarkers are being explored to enhance understanding and personalize treatment for different HF phenotypes.

Inflammation is crucial in the development of HF, and emerging biomarkers, including noncoding RNAs, may offer new avenues for diagnosis and monitoring, aligning with the trend towards precision medicine in healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel Biomarkers in Heart Failure: New Insight in Pathophysiology and Clinical Perspective. Biasucci, LM., Maino, A., Grimaldi, MC., et al.[2021]

Current biomarkers for heart failure have not yet proven to be reliable prognostic indicators in clinical practice, despite extensive research and numerous studies.

There is a need to identify specific clinical applications for these biomarkers to enhance their predictive performance and usefulness in patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Research needed to support clinical use of biomarkers as prognostic indicators for patients with heart failure. Rector, TS., Anand, IS.[2021]

In a pilot study involving 70 patients with Stage B heart failure, an 8-week gratitude journaling intervention led to significant improvements in trait gratitude scores and a reduction in inflammatory biomarkers, suggesting potential benefits for heart health.

The intervention also increased parasympathetic heart rate variability during the gratitude journaling task, indicating a positive effect on the autonomic nervous system, although no significant changes were observed in resting heart rate variability from pre- to post-intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Randomized Study of a Gratitude Journaling Intervention on Heart Rate Variability and Inflammatory Biomarkers in Patients With Stage B Heart Failure. Redwine, LS., Henry, BL., Pung, MA., et al.[2022]

Citations

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COMPASSION Digital Biomarker for Heart Failure Trial Overview The study is testing the COMPASSION Digital Biomarker to see if it can help improve outcomes for patients readmitted to the hospital due to heart ...

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Acute Decompensated Heart Failure Update - PMC The majority (80%) of patients hospitalized with heart failure present as an acute decompensation of chronic HF [1]. These patients become refractory to oral ...

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Biomarkers in Acute Heart Failure: Diagnosis, Prognosis, ... Two prior meta-analyses have generally shown improved outcomes with reduced mortality and HF hospitalization using an NP guided strategy.29)30) ...

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Mortality prediction in acute heart failure: scores or ... This review highlights recent advances and remaining uncertainties regarding risk stratification in AHF by characterising and comparing the potential of ...