Heart Failure Event Advance Detection Trial — HEADstart  

Heart Failure Clinical Trial

Official title: Noninvasive Home Assessment of Cardiac Filling Pressure to Identify Heart Failure Patients at High Risk for Readmission

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

The study will follow the design of a prospective observational cohort study. Patients who are admitted with acutely decompensated heart failure and are receiving intravenous diuretics will be recruited to undergo testing with the Indicor Device for estimating left ventricular end diastolic pressure (LVEDP). Trends in estimated LVEDP will be assessed after thirty days at home to identify trends that coincided with heart failure events.

The Indicor is a noninvasive device that assesses cardiac filling pressure based on the long understood phenomenon that performing a Valsalva maneuver induces changes in pulse pressure that reflect cardiac filling pressure.Testing with the Indicor consists of blowing into the device while performing a Valsalva Maneuver for 10 seconds, and the index finger will be placed inside a PPG sensor during the test. Each test consists of three recorded efforts with 45 seconds rest between efforts.

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. In order to proceed with home use, they will need to demonstrate the ability to properly operate the device and complete testing without assistance. Demographic and clinical data will also be collected including laboratories, comorbidities, and heart failure etiology. Once a subject demonstrates proper operation an Indicor will be provided to them for use at home for the study duration. Once the subjects are home, they will be asked to perform the test each morning and each evening.

In the AM, subjects will be asked to weigh themselves upon awakening after using the restroom, and will be asked to perform the device test afterward. Subjects will be asked six simple, standardized symptom-related questions:

1. Have you felt more short of breath during the last day?

2. Have you noticed more swelling in the last day?

3. Did you wake up short of breath last night?

4. Did you sleep in a chair, or prop up with pillows more than usual last night?

5. Have you had any lightheadedness or dizziness in the last day?

6. Enter morning weight.

No recorded data will be analyzed for the duration of the subject's participation, since this is purely an observational study. It will be stressed to the participant that, as always, they would need to report to their provider any worsening symptoms or change in weight as instructed by the discharge team or outpatient provider.

For each subject enrolled, 1 test twice a day will be obtained for up to 30 days. ;

Related Conditions & MeSH terms

• Congestive Heart Failure
• Decompensated Heart Failure
• Heart Failure

• NCT number: NCT04223271
• Study type: Observational
• Source: Vixiar Medical, Inc.
• Contact: Benjamin C Verschoore, BS
• Phone: 4435456094
• Email: bverschoore@vixiar.com
• Status: Recruiting
• Start date: February 4, 2020
• Completion date: April 30, 2021