Heart Failure Event Advance Detection Trial
HEADstart
Noninvasive Home Assessment of Cardiac Filling Pressure to Identify Heart Failure Patients at High Risk for Readmission
2 other identifiers
observational
165
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 6, 2020
CompletedFirst Posted
Study publicly available on registry
January 10, 2020
CompletedStudy Start
First participant enrolled
February 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2021
CompletedMay 19, 2020
March 1, 2020
1.2 years
January 6, 2020
May 18, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Association between change in estimated LVEDP and the occurrence of heart failure events.
Twice daily, non-invasive measures to estimate LVEDP (mmHg) will be retrospectively assessed to determine if changes or trends in estimated LVEDP were associated with, and therefore predictive of, 30-day readmission, mortality or need for intravenous diuretics in heart failure patients.
30 days post discharge
Study Arms (1)
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
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.
Eligibility Criteria
Any adult patient admitted to Johns Hopkins Hospital, or Johns Hopkins Bayview Medical Center with acutely decompensated heart failure (HFrEF or HFpEF) that does not meet any of the exclusion criteria.
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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vixiar Medical, Inc.lead
- Johns Hopkins Universitycollaborator
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
Study Sites (1)
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Harry A Silber, MD, PhD
Johns Hopkins University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 6, 2020
First Posted
January 10, 2020
Study Start
February 4, 2020
Primary Completion
April 30, 2021
Study Completion
April 30, 2021
Last Updated
May 19, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share