Recruiting

Observational Study

Sponsor:

Aventyn, Inc.

Code:

NCT04905160

Conditions

Heart Failure

ADHF

Acute MI

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

COMPASSION Digital Biomarker

Study Details

Brief 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.

Conditions

Heart Failure

ADHF

Acute MI

Study ID

NCT04905160

Start date

Feb 18, 2021

Status verified date

Mar, 2024

Completion date

Dec 22, 2026

Anticipated

Primary completion date

Feb 22, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

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

Study Design

Enrollment

1000 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Reducing readmissions [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Locations

Multiple Locations

Recruiting

Phoenix, Arizona, United States, 85016

More Information

Sponsor

Aventyn, Inc.

Last update posted

Mar 20, 2024

Last verified

Mar, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Aventyn, Inc. on 2024-03-20.