Heart Failure Event Advance Detection Trial
Status unconfirmed
Conditions studied: Congestive Heart Failure, Heart Failure, Decompensated Heart Failure
In brief
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.
Key facts
- Study ID
- NCT04223271
- Run by
- Vixiar Medical, Inc.
- People needed
- 165
- Starts
- 2020-02-04
- Expected to finish
- 2021-04-30
- Last updated by the study team
- 2020-05-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Admitted to Johns Hopkins Hospital, or Johns Hopkins Bayview Medical Center with acutely decompensated heart failure (HFrEF or HFpEF)
- Requires IV diuresis
You may not qualify if…
- 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
Where it is running
- Johns Hopkins Hospital — Baltimore, Maryland, United States (enrolling)
Full record on ClinicalTrials.gov
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