RecruitingNot ApplicableNCT04905160

Care Coordination to Assess Improvement in Outcomes in Hospital Readmissions

Care cOordination Using Mobile Technology to Enhance Patient Empowerment in Acute Comorbidities to aSSess Improvement in Outcomes in Hospital readmissioNs

Sponsor

Aventyn, Inc.

Enrollment

1,000 participants

Start Date

Feb 18, 2021

Study Type

INTERVENTIONAL

Conditions

Heart Failure ADHF Acute MI

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. Clinically, HF patients experience dyspnea, fatigue and diminished exercise tolerance, reflecting elevated left and/or right ventricular filling pressures and decreased cardiac output.

Eligibility

Min Age: 18 Years

Inclusion Criteria1

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.

Exclusion Criteria5

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

Interventions

OTHERCOMPASSION Digital Biomarker

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.