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Clinical Trials in the USA / NCT04905160
Recruiting Not applicable

Care Coordination to Assess Improvement in Outcomes in Hospital Readmissions

NCT04905160 · tracked via the Priya Life Science USA tracker
Sponsor
Aventyn, Inc
Phase
Not applicable
Started
2021-02-18
Last updated
2024-03-20

Condition(s) studied

Heart FailureADHFAcute MI

Investigational drug(s) / intervention(s)

COMPASSION Digital Biomarker

COMPASSION 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.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: 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 Criteria: 1. Study informed consent will be obtained before enrollment in the study for Phase 1 and Phase 2 2. All subjects 18 years or above will be a criteria for inclusion for Phase 1 3. 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; 4. For phase 2, subjects should be able to be randomized within 48 hours of Covid19 antigen positive status 5. Patients considered unreliable by the investigator concerning the requirements for follow-up visits

Primary outcome measure(s)

  • Reducing readmissions — 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.

Trial sites (1)

FacilityCityRegionStatus
Multiple Locations Phoenix Arizona Recruiting

More Aventyn, Inc. trials in the USA

Cardiovascular Kidney and Metabolic Health Assessment and Patient Empowerment Recruiting

Other trials for the same condition

REDUCE LAP-HFREF TRIAL Active, not recruiting
Real World Effectiveness of the Cordella Pulmonary Artery Sensor System in Patients With Chronic Heart Heart Failure Recruiting
The WiSE®-UP Study (The WiSE System Utilization & Performance Study) Recruiting
Use of the Impella BTR™ in Patients With Heart Failure: An Early Feasibility Study Active, not recruiting
The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With FMR Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04905160 on ClinicalTrials.gov ↗ ← All trials in the USA