Heart FailureNCT02406820
Correlating Noninvasive Cardiovascular Measures to Left Ventricular End Diastolic Pressure in Heart Failure
An observational study of Heart Failure, run by Intelomed, Inc. at 1 site in United States.
Trial summary
HF001 is a prospective observational study utilizing non-invasive medical devices that may be able to discriminate changes in heart failure while acutely decompensated patients undergo routine interventional therapies in a hospital setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Non-invasive hemodynamic monitoring (CVInsight™ [CVI])
- Type of treatment
- Medical device
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Mar 2016
- 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: Acutely decompensated heart failure patients admitted to acute care setting, who require a right heart catheterization.
Who may be able to join
- Adult patients ≥ 18 years old
- Signs and symptoms of congestive heart failure including two of the following:
- Peripheral edema (e.g. abdominal distension, hepatomegaly, lower extremity edema) in the setting of elevated jugular venous pressure as assessed by the clinical examination, or by right heart catheterization.
- Pulmonary edema or pleural effusion as seen on chest X-ray
- Elevated N-terminal pro-brain natriuretic peptide (NT-Pro BNP) 2x the upper limit of normal.
- Willing and able to comply with the study protocol
- Willing and able to give valid Informed Consent
Who cannot join
- Pregnant patients
- Presence of Left Ventricular Assist Device (LVAD) or heart transplant
- Complex congenital heart disorder or prosthetic valve on right side
- Known mitral stenosis
- Unstable medical condition or impairment other than condition associated with HF
- Unstable hypertension
Show all 14Show fewer
- Too unstable in the judgment of the investigator to be included in the study
- Active lung infection or acute pulmonary decompensation
- Elevated white blood cell count and signs of infection are evident
- Does not have the cognitive ability to understand and sign the Informed Consent
- Does not have the cognitive capacity to perform handgrip test
- Is not able to perform a handgrip stress test
- Is not able to wear any of the devices
- Patient's life expectancy is less than 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010-2975
About this study
Official title: Characterizing Noninvasive Cardiovascular Measures Collected Passively and In Response to an Isometric Handgrip Stress Test From CVInsight®, Connex ProBP, and Zio® XT Patch in Patients With Acute Decompensated Heart Failure
HF001 is a prospective observational study utilizing non-invasive medical devices that may be able to discriminate changes in heart failure while acutely decompensated patients undergo routine interventional therapies in a hospital setting. Subjects will be monitored using CVInsight™ [CVI] via a finger and/or forehead sensor, while performing an isometric handgrip stress test (IHGST). Changes in the CVI signal will be analyzed and correlated to standard assessments of heart failure including pulmonary artery catheter (PAC) pressures, blood pressure (BP), patient symptoms, and physical exam findings. The results of this study will be used to develop a powered study to determine if a new configuration of non-invasive monitoring devices can be used to monitor heart failure status more sensitively than current non-invasive techniques.
- Conditions
- Heart Failure
- Being tested
- Non-invasive hemodynamic monitoring (CVInsight™ [CVI])
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive hemodynamic monitoring (CVInsight™ [CVI])Device
| Study group | Role | What they receive |
|---|---|---|
| No Indwelling PAC, Daily Testing | Acutely decompensated heart failure patients undergoing a right heart catheterization for whom a retained indwelling PAC is not clinically indicated and who are registered to twice daily non-invasive hemodynamic monitoring during an isometric handgrip stress test (IHGST). Receives: Device: Non-invasive hemodynamic monitoring (CVInsight™ [CVI]) | |
| Indwelling PAC, Daily Testing | Acutely decompensated heart failure patients undergoing a right heart catheterization for whom a retained indwelling PAC is clinically indicated and who are registered to three times daily non-invasive hemodynamic monitoring during an isometric handgrip stress test (IHGST). Receives: Device: Non-invasive hemodynamic monitoring (CVInsight™ [CVI]) | |
| No Indwelling PAC, No Daily Testing | Acutely decompensated heart failure patients undergoing a right heart catheterization for whom a retained indwelling PAC is clinically indicated and who are registered to no daily non-invasive hemodynamic monitoring during an isometric handgrip stress test (IHGST). Receives: Device: Non-invasive hemodynamic monitoring (CVInsight™ [CVI]) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of correlation between CVInsight signals and Pulmonary Capillary Wedge Pressure or Pulmonary Artery Pressure
Measured: Upon completion of catheter assessments for all enrolled subjects, approximately 6 months from study activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionMar 2016
- Study completionMar 2016
Why it stopped: Strategic closure by sponsor to pursue other indications.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intelomed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Majure, MD, Principal investigator, MedStar Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02406820
- Sponsor's protocol ID
- HF001
- Status last verified
- Aug 2016
- First submitted
- 26 Mar 2015
- Last updated
- 30 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing Noninvasive Cardiovascular Measures Collected Passively and In Response to an Isometric Handgrip Stress Test From CVInsight®, Connex ProBP, and Zio® XT Patch in Patients With Acute Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT02406820
- Acronym / sponsor ID
- HF001
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Strategic closure by sponsor to pursue other indications.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Intelomed, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 2 Apr 2015 (estimated)
- 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.
HF001 is a prospective observational study utilizing non-invasive medical devices that may be able to discriminate changes in heart failure while acutely decompensated patients undergo routine interventional therapies in a hospital setting. Subjects will be monitored using CVInsight™ [CVI] via a finger and/or forehead sensor, while performing an isometric handgrip stress test (IHGST). Changes in the CVI signal will be analyzed and correlated to standard assessments of heart failure including pulmonary artery catheter (PAC) pressures, blood pressure (BP), patient symptoms, and physical exam findings. The results of this study will be used to develop a powered study to determine if a new configuration of non-invasive monitoring devices can be used to monitor heart failure status more sensitively than current non-invasive techniques.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No Indwelling PAC, Daily Testing | – | Device: Non-invasive hemodynamic monitoring (CVInsight™ [CVI])Acutely decompensated heart failure patients undergoing a right heart catheterization for whom a retained indwelling PAC is not clinically indicated and who are registered to twice daily non-invasive hemodynamic monitoring during an isometric handgrip stress test (IHGST). |
| Indwelling PAC, Daily Testing | – | Device: Non-invasive hemodynamic monitoring (CVInsight™ [CVI])Acutely decompensated heart failure patients undergoing a right heart catheterization for whom a retained indwelling PAC is clinically indicated and who are registered to three times daily non-invasive hemodynamic monitoring during an isometric handgrip stress test (IHGST). |
| No Indwelling PAC, No Daily Testing | – | Device: Non-invasive hemodynamic monitoring (CVInsight™ [CVI])Acutely decompensated heart failure patients undergoing a right heart catheterization for whom a retained indwelling PAC is clinically indicated and who are registered to no daily non-invasive hemodynamic monitoring during an isometric handgrip stress test (IHGST). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acutely decompensated heart failure patients admitted to acute care setting, who require a right heart catheterization.
Key inclusion criteria (7 listed)
- Adult patients ≥ 18 years old
- Signs and symptoms of congestive heart failure including two of the following:
- Peripheral edema (e.g. abdominal distension, hepatomegaly, lower extremity edema) in the setting of elevated jugular venous pressure as assessed by the clinical examination, or by right heart catheterization.
- Pulmonary edema or pleural effusion as seen on chest X-ray
- Elevated N-terminal pro-brain natriuretic peptide (NT-Pro BNP) 2x the upper limit of normal.
Key exclusion criteria (14 listed)
- Pregnant patients
- Presence of Left Ventricular Assist Device (LVAD) or heart transplant
- Complex congenital heart disorder or prosthetic valve on right side
- Known mitral stenosis
- Unstable medical condition or impairment other than condition associated with HF
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 |
|---|---|---|
| Non-invasive hemodynamic monitoring (CVInsight™ [CVI]) | Device | Indwelling PAC, Daily Testing, No Indwelling PAC, Daily Testing, No Indwelling PAC, No Daily Testing |
Primary outcome
Evidence of correlation between CVInsight signals and Pulmonary Capillary Wedge Pressure or Pulmonary Artery Pressure
Time frame: Upon completion of catheter assessments for all enrolled subjects, approximately 6 months from study activation
Results and safety
The study was stopped early (reason given: Strategic closure by sponsor to pursue other indications.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2016.
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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.
David Majure, MD principal investigator
MedStar Health
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 Heart Failure, run by Intelomed, 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 7 inclusion and 14 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: stopped early, as of the sponsor's last update on 30 Aug 2016. 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?
The study was stopped early (reason given: Strategic closure by sponsor to pursue other indications.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of correlation between CVInsight signals and Pulmonary Capillary Wedge Pressure or Pulmonary Artery Pressure (time frame: Upon completion of catheter assessments for all enrolled subjects, approximately 6 months from study activation). 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 30 Aug 2016.