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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
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• 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.

Locations
United States
Arizona
Multiple Locations
RECRUITING
Phoenix
Contact Information
Primary
Navin Govind
vitalbeat@aventyn.com
2317942328
Backup
Sharolynn Mclurg
Time Frame
Start Date: 2021-02-18
Estimated Completion Date: 2026-12-22
Participants
Target number of participants: 1000
Treatments
Experimental: Subjects Hospitalized with a Primary Diagnosis of ADHF or Acute MI
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.
Experimental: Subjects Testing Positive Covid-19 Antigen Test
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.
Related Therapeutic Areas
Sponsors
Collaborators: Arizona State University, Intel Corporation, Heart Health Organization East Valley, TwinEpidemic
Leads: Aventyn, Inc.

This content was sourced from clinicaltrials.gov