Congestive Heart FailureHEADstartNCT04223271
Heart Failure Event Advance Detection Trial
An observational study of Congestive Heart Failure and Heart Failure, run by Vixiar Medical, Inc. at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure, Heart Failure, Decompensated Heart Failure
- What is being tested?
- Indicor
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 165 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2020to 30 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Admitted to Johns Hopkins Hospital, or Johns Hopkins Bayview Medical Center with acutely decompensated heart failure (HFrEF or HFpEF)
- Requires IV diuresis
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Nisha A Gilotra, MD, 410-502-0820, naggarw2@jhmi.edu
Benjamin C Verschoore, BS, 4435456094, bversch1@jhmi.edu
About this study
Official title: Noninvasive Home Assessment of Cardiac Filling Pressure to Identify Heart Failure Patients at High Risk for Readmission
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.
Read the detailed 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:
- Have you felt more short of breath during the last day?
- Have you noticed more swelling in the last day?
- Did you wake up short of breath last night?
- Did you sleep in a chair, or prop up with pillows more than usual last night?
- Have you had any lightheadedness or dizziness in the last day?
- 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.
- Being tested
- Indicor
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IndicorDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Indicor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start4 Feb 2020
- Primary completion30 Apr 2021 (estimated)
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vixiar Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Harry A Silber, MD, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04223271
- Sponsor's protocol ID
- PROT000035
- Other IDs
- 1R42HL136162
- Acronym
- HEADstart
- Status last verified
- Mar 2020
- First submitted
- 6 Jan 2020
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Home Assessment of Cardiac Filling Pressure to Identify Heart Failure Patients at High Risk for Readmission
- ClinicalTrials.gov ID
- NCT04223271
- Acronym / sponsor ID
- HEADstart / PROT000035
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Vixiar Medical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Johns Hopkins University, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 4 Feb 2020 (actual)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 10 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- Have you felt more short of breath during the last day?
- Have you noticed more swelling in the last day?
- Did you wake up short of breath last night?
- Did you sleep in a chair, or prop up with pillows more than usual last night?
- Have you had any lightheadedness or dizziness in the last day?
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acutely Decompensated Heart Failure Patients | – | Diagnostic Test: IndicorPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- Admitted to Johns Hopkins Hospital, or Johns Hopkins Bayview Medical Center with acutely decompensated heart failure (HFrEF or HFpEF)
- Requires IV diuresis
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IndicorHandheld 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. | Diagnostic test | Acutely Decompensated Heart Failure Patients |
Primary outcome
Association between change in estimated LVEDP and the occurrence of heart failure events.
Time frame: 30 days post discharge
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harry A Silber, MD, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congestive Heart Failure and Heart Failure, run by Vixiar Medical, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benjamin C Verschoore, BS (4435456094, bverschoore@vixiar.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between change in estimated LVEDP and the occurrence of heart failure events. (time frame: 30 days post discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2020; AzTrials last refreshed its copy on 28 Oct 2026.