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COMPASSION Digital Biomarker for Heart Failure (COMPASSION Trial)

N/A
Recruiting
Led By Zaki Lababidi, MD
Research Sponsored by Aventyn, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The diagnosis of HF is established by the presence of typical symptoms, signs, and objective evidence of pulmonary congestion, elevated BNP or N-terminal pro B-type natriuretic peptide (NT-pro BNP) or impaired cardiac function
Eligible subjects must be hospitalized with a primary diagnosis of ADHF or acute MI
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights

COMPASSION Trial Summary

This trial is investigating whether an investigational medication can improve the symptoms of heart failure.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves a digital biomarker rather than medication, traditional side effects related to drugs are not applicable. However, there may be privacy concerns regarding personal health data collection.

COMPASSION Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have heart failure confirmed by symptoms, tests showing lung congestion, or high BNP/NT-proBNP levels.
Select...
I am hospitalized with acute heart failure or a recent heart attack.
Select...
I was diagnosed with a heart attack due to symptoms and tests.

COMPASSION Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Reducing readmissions
Secondary outcome measures
Well-being Self-assessed Likert scale at 30 days from hospitalization

COMPASSION Trial Design

2Treatment groups
Experimental Treatment
Group I: Subjects Testing Positive Covid-19 Antigen TestExperimental Treatment1 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 MIExperimental Treatment1 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.

Find a Location

Who is running the clinical trial?

Aventyn, Inc.Lead Sponsor
4 Previous Clinical Trials
27,086 Total Patients Enrolled
2 Trials studying Heart Failure
76 Patients Enrolled for Heart Failure
TwinEpidemicUNKNOWN
Arizona State UniversityOTHER
282 Previous Clinical Trials
107,974 Total Patients Enrolled
4 Trials studying Heart Failure
4,145 Patients Enrolled for Heart Failure

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can new patients still enroll in this research project?

"This trial is currently seeking participants, as reported on clinicaltrials.gov. The trial was originally posted on 2/18/2021 and was most recently edited on 6/14/2021."

Answered by AI

How many people are enlisted in this clinical trial currently?

"Yes, the information available on clinicaltrials.gov indicates that this trial is currently looking for participants. The listing was created on February 18th 2021 and updated most recently on June 14th 2021. They are recruiting from a single site but need 1000 patients in total."

Answered by AI
~208 spots leftby Feb 2025