Health TrialsbyHealthPanel

Care Coordination to Assess Improvement in Outcomes in Hospital Readmissions

ConditionsHeart FailureADHFAcute MI
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAventyn, Inc.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • COMPASSION Digital Biomarker

    Other intervention

    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.

Treatment groups

1,000 Participants
are divided into 2 treatment groups
Group A: Subjects Hospitalized with a Primary Diagnosis of ADHF or Acute MIExperimental treatment 1 intervention
Group B: Subjects Testing Positive Covid-19 Antigen TestExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
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

Time frame
30 Days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aventyn, Inc.

Lead sponsor

TwinEpidemic

Collaborator

Arizona State University

Collaborator

Intel Corporation

Collaborator

Heart Health Organization East Valley

Collaborator

Source ClinicalTrials.gov
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