Actively Recruiting

Phase Not Applicable
Age: 22Years +
All Genders
NCT04149743

HEMOTAG® Assessment for Short-term Outcomes of Heart Failure

Led by Aventusoft, LLC. · Updated on 2024-08-21

420

Participants Needed

2

Research Sites

147 weeks

Total Duration

On this page

Sponsors

A

Aventusoft, LLC.

Lead Sponsor

N

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Evaluation of the HEMOTAG® system in a less controlled environment and concurrently develop the system for use by patients with heart failure.

CONDITIONS

Official Title

HEMOTAG® Assessment for Short-term Outcomes of Heart Failure

Who Can Participate

Age: 22Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age greater than or equal to 22 years old.
  • Recent hospital admission for acute decompensated heart failure with symptoms, clinical signs, and chest x-ray showing lung congestion.
  • Receiving intravenous diuretics or vasoactive drugs during hospital admission.
  • Brain natriuretic peptide (BNP) greater than 350 or NT-pro BNP greater than 1800 pg/ml.
  • Able to provide informed consent.
  • Residence with adequate cellular data coverage.
  • If previously diagnosed with left ventricular ejection fraction less than 40%, treated for at least 90 days before enrollment with diuretics, beta-blocker (unless intolerant), and ACE inhibitor, ARB, or ARNi (unless intolerant).
Not Eligible

You will not qualify if you...

  • Unable to provide informed, voluntary consent as determined by the investigator.
  • Terminal condition with life expectancy less than 6 months.
  • Cardiac tamponade or constrictive pericarditis.
  • Having a left ventricular assistance device, cardiac transplantation, or listed for transplantation.
  • Implantation or planned implantation of a cardiac resynchronization therapy device during index hospitalization.
  • Significant mitral or aortic valve disease (except mitral regurgitation due to left ventricular dilation).
  • Significant obstructive lesions of the left ventricular outflow tract.
  • Severe primary pulmonary, renal, or hepatic disease.
  • Women of childbearing age under 50 years.
  • History of pulmonary embolism within the last 3 months.
  • Dialysis dependent or expected dialysis initiation within 3 months.
  • Chronic home intravenous therapy or cardiac inotropes or diuretics.
  • Chest deformity or lesion preventing proper HEMOTAG application.
  • Skin issues or intolerance to skin electrodes preventing device use.
  • Impaired cognitive ability or inability to comply with study protocol.
  • Complex or uncorrected congenital heart malformations.
  • Participation in another interventional study.
  • Heart failure managed remotely with certain other monitoring devices or programs.
  • Prisoners or wards of the state.
  • Inability to provide informed consent in English, Spanish, or Creole.

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Cleveland Clinic Florida

Weston, Florida, United States, 33331

Actively Recruiting

2

Baylor Scott & White Research Institute

Temple, Texas, United States, 76508

Actively Recruiting

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Research Team

C

Cindy Kober

CONTACT

K

Kaustubh Kale

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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