Heart FailureCOMPASSIONNCT04905160
Care Coordination to Assess Improvement in Outcomes in Hospital Readmissions
A study testing COMPASSION Digital Biomarker in people with Heart Failure and ADHF, run by Aventyn, Inc. at 1 site in United States.
Trial summary
Heart failure is a syndrome that is defined by distinctive clinical, hemodynamic, and neurohormonal findings. HF represents a final common pathway for many different cardiovascular diseases, including coronary disease, hypertension, Valvular disease, and many primary heart muscle diseases. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, ADHF, Acute MI
- What is being tested?
- COMPASSION Digital Biomarker
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2021to 22 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women over 18 years of age are included. Eligible subjects must be hospitalized with a primary diagnosis of ADHF or acute MI. 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. Acute MI is diagnosed by presence of chest pain, arm pain, or dyspnea with elevated Troponin and/or EKG changes suggestive of Acute coronary syndrome requiring intervention or optimal medical therapy.
Who cannot join
- Study informed consent will be obtained before enrollment in the study for Phase 1 and Phase 2
- All subjects 18 years or above will be a criteria for inclusion for Phase 1
- For Phase 2, men and women 50 years or older with positive Covid19 antigen test and one other risk factor as mentioned in the comorbid section of workflow will be enrolled in the intervention arm of the study;
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sharolynn Mclurg contact
United States1 site, 1 recruiting
- Recruiting
Multiple Locations
Phoenix, Arizona, 85016
Puja Chandler
About this study
Official title: Care cOordination Using Mobile Technology to Enhance Patient Empowerment in Acute Comorbidities to aSSess Improvement in Outcomes in Hospital readmissioNs
Heart failure is a syndrome that is defined by distinctive clinical, hemodynamic, and neurohormonal findings. HF represents a final common pathway for many different cardiovascular diseases, including coronary disease, hypertension, Valvular disease, and many primary heart muscle diseases. Clinically, HF patients experience dyspnea, fatigue and diminished exercise tolerance, reflecting elevated left and/or right ventricular filling pressures and decreased cardiac output.
Read the detailed description
Heart failure patients are frequently hospitalized and have a high mortality rate and accounts for over 1 million hospital admissions yearly in the U.S. It is associated with a 2-year mortality rate of up to 40% to 50. The annual mortality rate for Acute Decompensated Heart Failure (ADHF) is 21%. ADHF initial hospitalization mortality rates range from 4% to 7%, with mortality as high as 22% in high risk patients. About 30% to 60% of ADHF patients are readmitted within 3-6 months after discharge from the first hospitalization. Inpatient treatment for ADHF consists of diuretics, vasodilators and inotropes. Hospital admissions for ADHF have increased precipitously during the past few decades and are projected to continue to increase in the future. To optimize patient outcomes and reduce the costs associated with this disorder, evidenced-based device and pharmacotherapy is essential. Diuretics, Beta blockers, RAAS blockers and cardiac resynchronization therapy are all useful to some extent in improving outcomes of quality of life and survival. In spite of optimized therapy, there is still relentless progression of disease and clinical exacerbations of fluid retention that precipitates hospital admissions and readmissions increasing poor quality outcomes as well as the cost burden for individual, hospitals, ACOs, payers and society as a whole. There is an urgent need to decrease hospital readmissions in Post Myocardial Infarction patients and subjects with recurrent CHF. This project will use patient empowerment and new technologies to increase QOL of patients as well as to reduce readmissions
- Conditions
- Heart Failure, ADHF, Acute MI
- Being tested
- COMPASSION Digital Biomarker
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COMPASSION Digital BiomarkerOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Subjects Hospitalized with a Primary Diagnosis of ADHF or Acute MI | Experimental | 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. Receives: Other: COMPASSION Digital Biomarker |
| Subjects Testing Positive Covid-19 Antigen Test | Experimental | 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. Receives: Other: COMPASSION Digital Biomarker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reducing readmissions
The primary objective of this study is to evaluate the efficacy of treatment strategy in reducing readmissions based on the COMPASSION algorithm obtained from biomarkers and diagnostics utilizing remote sensor driven technology tools, care coordination and patient empowerment. Improvement of patient outcomes will be measured by reduction of composite of HF re-hospitalization and all-cause mortality through 30 days in patients with recent acute Myocardial Infarction and recent admission for decompensated heart failure.
Measured: 30 days
Secondary outcomes (1)
Well-being Self-assessed Likert scale at 30 days from hospitalization
The secondary objectives of this study are to evaluate the effect of treatment in:
Improving subject self-assessed overall well-being as measured by self-assessed Likert scale at 30 days from hospitalization Increasing the number of days alive and outside the hospital from hospitalization through day 30. Reducing the composite of cardiovascular re-hospitalization and Cardiovascular mortality from hospitalization through 30 days
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start18 Feb 2021
- Primary completion22 Feb 2025 (estimated)
- Study completion22 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Evaluate the efficacy of treatment strategy in reducing readmissions based on an algorithm obtained from biomarkers and diagnostics utilizing remote sensor driven technology tools, care coordination and patient empowerment. Improvement of patient outcomes will be measured by reduction of composite of HF re-hospitalization and all-cause mortality through 30 days,90 days and 180 days in patients with recent acute Myocardial Infarction and recent admission for decompensated heart failure
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aventyn, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- TwinEpidemic, Arizona State University, Intel Corporation, Heart Health Organization East Valley
- Responsible party
- Sponsor
- Investigators
- Kris Vijay, MD, Study chair, Abrazo Arizona HeartRaj Bhat, MD, Study director, Pioneer HospitalistsZaki Lababidi, MD, Principal investigator, Gilbert CardiologyAshok Solsi, MD, Principal investigator, Premier Cardiovascular Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04905160
- Sponsor's protocol ID
- AVDH 001
- Acronym
- COMPASSION
- Status last verified
- Mar 2024
- First submitted
- 24 May 2021
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Care cOordination Using Mobile Technology to Enhance Patient Empowerment in Acute Comorbidities to aSSess Improvement in Outcomes in Hospital readmissioNs
- ClinicalTrials.gov ID
- NCT04905160
- Acronym / sponsor ID
- COMPASSION / AVDH 001
- Conditions
- Heart Failure, ADHF, Acute MI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Aventyn, Inc.Industry (pharma, biotech, devices)
- Collaborators
- TwinEpidemic, Arizona State University, Intel Corporation, Heart Health Organization East Valley
- Study start
- 18 Feb 2021 (actual)
- Primary completion
- 22 Feb 2025 (estimated)
- Study completion
- 22 Dec 2026 (estimated)
- First posted
- 27 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Heart failure is a syndrome that is defined by distinctive clinical, hemodynamic, and neurohormonal findings. HF represents a final common pathway for many different cardiovascular diseases, including coronary disease, hypertension, Valvular disease, and many primary heart muscle diseases. Clinically, HF patients experience dyspnea, fatigue and diminished exercise tolerance, reflecting elevated left and/or right ventricular filling pressures and decreased cardiac output.
Detailed description
Heart failure patients are frequently hospitalized and have a high mortality rate and accounts for over 1 million hospital admissions yearly in the U.S. It is associated with a 2-year mortality rate of up to 40% to 50. The annual mortality rate for Acute Decompensated Heart Failure (ADHF) is 21%. ADHF initial hospitalization mortality rates range from 4% to 7%, with mortality as high as 22% in high risk patients. About 30% to 60% of ADHF patients are readmitted within 3-6 months after discharge from the first hospitalization. Inpatient treatment for ADHF consists of diuretics, vasodilators and inotropes. Hospital admissions for ADHF have increased precipitously during the past few decades and are projected to continue to increase in the future. To optimize patient outcomes and reduce the costs associated with this disorder, evidenced-based device and pharmacotherapy is essential. Diuretics, Beta blockers, RAAS blockers and cardiac resynchronization therapy are all useful to some extent in improving outcomes of quality of life and survival. In spite of optimized therapy, there is still relentless progression of disease and clinical exacerbations of fluid retention that precipitates hospital admissions and readmissions increasing poor quality outcomes as well as the cost burden for individual, hospitals, ACOs, payers and society as a whole. There is an urgent need to decrease hospital readmissions in Post Myocardial Infarction patients and subjects with recurrent CHF. This project will use patient empowerment and new technologies to increase QOL of patients as well as to reduce readmissions
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Evaluate the efficacy of treatment strategy in reducing readmissions based on an algorithm obtained from biomarkers and diagnostics utilizing remote sensor driven technology tools, care coordination and patient empowerment. Improvement of patient outcomes will be measured by reduction of composite of HF re-hospitalization and all-cause mortality through 30 days,90 days and 180 days in patients with recent acute Myocardial Infarction and recent admission for decompensated heart failure
| Arm | Type | Receives |
|---|---|---|
| Subjects Hospitalized with a Primary Diagnosis of ADHF or Acute MI | Experimental | Other: COMPASSION Digital BiomarkerPhase 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. |
| Subjects Testing Positive Covid-19 Antigen Test | Experimental | Other: COMPASSION Digital BiomarkerPhase 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men and women over 18 years of age are included. Eligible subjects must be hospitalized with a primary diagnosis of ADHF or acute MI. 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. Acute MI is diagnosed by presence of chest pain, arm pain, or dyspnea with elevated Troponin and/or EKG changes suggestive of Acute coronary syndrome requiring intervention or optimal medical therapy.
Key exclusion criteria (5 listed)
- Study informed consent will be obtained before enrollment in the study for Phase 1 and Phase 2
- All subjects 18 years or above will be a criteria for inclusion for Phase 1
- For Phase 2, men and women 50 years or older with positive Covid19 antigen test and one other risk factor as mentioned in the comorbid section of workflow will be enrolled in the intervention arm of the study;
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COMPASSION Digital BiomarkerVitals data collected by the Vitalbeat workbench for biomarker based algorithm variables will be used to drive intervention based on PAP systolic and diastolic pressures. | Other | Subjects Hospitalized with a Primary Diagnosis of ADHF or Acute MI, Subjects Testing Positive Covid-19 Antigen Test |
Primary outcome
Reducing readmissions
Time frame: 30 days
The primary objective of this study is to evaluate the efficacy of treatment strategy in reducing readmissions based on the COMPASSION algorithm obtained from biomarkers and diagnostics utilizing remote sensor driven technology tools, care coordination and patient empowerment. Improvement of patient outcomes will be measured by reduction of composite of HF re-hospitalization and all-cause mortality through 30 days in patients with recent acute Myocardial Infarction and recent admission for decompensated heart failure.
1 secondary outcome
Well-being Self-assessed Likert scale at 30 days from hospitalization
Time frame: 30 Days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sharolynn Mclurg contact
Kris Vijay, MD study chair
Abrazo Arizona Heart
Raj Bhat, MD study director
Pioneer Hospitalists
Zaki Lababidi, MD principal investigator
Gilbert Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COMPASSION Digital Biomarker in people with Heart Failure and ADHF, run by Aventyn, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Navin Govind (2317942328, vitalbeat@aventyn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reducing readmissions (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.