Recruiting

Indicor Device

Sponsor:

Vixiar Medical, Inc.

Code:

NCT04223271

Conditions

Congestive Heart Failure

Heart Failure

Decompensated Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Indicor

Study Details

Brief 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

Study ID

NCT04223271

Start date

Feb 4, 2020

Status verified date

Mar, 2020

Completion date

Apr 30, 2021

Anticipated

Primary completion date

Apr 30, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Admitted to Johns Hopkins Hospital, or Johns Hopkins Bayview Medical Center with acutely decompensated heart failure (HFrEF or HFpEF)
  • Requires IV diuresis

Exclusion Criteria:

  • Acute coronary syndrome (type 1 myocardial infarction)
  • Terminal non-cardiac illness (that can affect short term prognosis)
  • Operative cardiac procedure during admission (bypass, valve, transplant, LVAD)
  • End-stage renal disease on dialysis
  • Pregnant women (as verbally indicated by patients being approached for recruitment, or through clinically indicated pregnancy tests ordered by the patient's clinicians)
  • History of paradoxical emboli
  • Hypertrophic obstructive cardiomyopathy
  • Known intracardiac shunt
  • Known severe aortic valve stenosis
  • Known severe mitral valve stenosis
  • Myocardial infarction within one week of intended Indicor testing
  • Uncontrolled hypertension (systolic BP >160mmHg or diastolic BP> 100mmHg)
  • Hypotension (systolic BP <90mmHg)
  • Symptomatic bradycardia
  • Known cholesterol emboli
  • Poor left ventricular function with left ventricular thrombus
  • Unstable angina

Study Design

Enrollment

165 participants

Anticipated

Interventions and Outcome Measures

Arms

Acutely Decompensated Heart Failure Patients

Patients who are admitted with acutely decompensated heart failure and are receiving intravenous diuretics will be recruited to undergo testing. Testing with the Indicor device will occur every day during hospitalization, and twice a day for up to 30 days after discharge.

Interventions

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.

Primary outcome measure

  • Association between change in estimated LVEDP and the occurrence of heart failure events. [ Time Frame: 30 days post discharge ]

Central Contacts and Locations

Central contacts

Benjamin C Verschoore, BS

4435456094bverschoore@vixiar.com

Thomas L Miller, PhD

(856) 279-1227tmiller@vixiar.com

Locations

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Nisha A Gilotra, MD

410-502-0820naggarw2@jhmi.edu

Benjamin C Verschoore, BS

4435456094bversch1@jhmi.edu

Principal Investigator:

Nisha A Gilotra, MD

More Information

Sponsor

Vixiar Medical, Inc.

Last update posted

May 19, 2020

Last verified

Mar, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vixiar Medical, Inc. on 2020-05-19.