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Heart Failure Event Advance Detection Trial

NCT04223271 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 165

Last updated 2020-05-19

No results posted yet for this study

Summary

Patients who are admitted with acutely decompensated heart failure and are receiving intravenous diuretics will be recruited to undergo testing using the Indicor Device. Participants will be tested daily while hospitalized and then on the day of discharge during which time they will be trained how to operate the device. Once discharged, patients will perform one test in the morning, and one test in the evening for up to 30 days.

Conditions

  • Congestive Heart Failure
  • Heart Failure
  • Decompensated Heart Failure

Interventions

DIAGNOSTIC_TEST

Indicor

Handheld device with attached PPG sensor that is paired with a tablet to estimate left ventricular end diastolic pressure. Subjects will blow into the device in order to perform a standardized Valsalva maneuver for 10 seconds. The index finger will be resting in the PPG sensor during the test. Each test requires three efforts, with 45 seconds rest between efforts.

Sponsors & Collaborators

  • Johns Hopkins University

    collaborator OTHER

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Vixiar Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Harry A Silber, MD, PhD · Johns Hopkins University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-04
Primary Completion
2021-04-30
Completion
2021-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04223271 on ClinicalTrials.gov