Continous Flow Left Ventricular DeviceRamp-it-UpNCT03021239
Impact of Hemodynamic Ramp Test-Guided HVAD RPM and Medication Adjustments on Exercise Tolerance and Quality of Life
A study testing Echo Guided Testing and Hemodynamic-Echo Ramp Testing - in people with Continous Flow Left Ventricular Device, run by University of Chicago at 8 sites in United States.
Trial summary
The main purpose of this study is to compare Echo-guided testing to the Hemodynamic-Echo Ramp Tests to determine which method of testing provides better information for adjusting pump speed and medical treatment for Left Ventricular Assist Device (LVAD) patients. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Continous Flow Left Ventricular Device
- What is being tested?
- Echo Guided Testing and Hemodynamic-Echo Ramp Testing -
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 8 sitesUnited States
- Study dates
- Mar 2016to Apr 2019
- Phase
- Interventional
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient older than 18 years
- Newly implanted HVAD
- HVAD support anticipated for at least 6 months
- Patient is ambulatory and discharged from hospital without inotropes
- Patient is between 1 and 3 months post implant
- Patient has not had a right heart catheterization since discharged from HVAD implantation hospitalization
Who cannot join
- The current HVAD is a replacement device
- Patients currently has Right Ventricle (RV) failure requiring home inotropes
- Inability to preformed right heart cath
- Inadequate echocardiographic windows
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Northwestern University
Chicago, Illinois
The University of Chicago
Chicago, Illinois
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania
UC San Diego Medical Center
San Diego, California
University of Washington School of Medicine
Seattle, Washington
Stanford Medical Center
Stanford, California
Montefiore Medical Center
The Bronx, New York
About this study
Official title: Impact of Hemodynamic Ramp Test-Guided HVAD RPM and Medication Adjustments on Exercise Tolerance and Quality of Life: A Multicenter Study
The main purpose of this study is to compare Echo-guided testing to the Hemodynamic-Echo Ramp Tests to determine which method of testing provides better information for adjusting pump speed and medical treatment for Left Ventricular Assist Device (LVAD) patients. Better adjustments may provide better quality of life, exercise tolerance and reduced unwanted cardiac events over a 6-month period.
Read the detailed description
All Left Ventricular Assist Device (LVAD)patients undergo testing to determine the best pumping speed for their Left Ventricular Assist Device (LVAD) and to gather measurements that help guide medical treatment. The testing uses echocardiography ("echo", ultrasound images of the heart) to create heart images and make measurements while gradually increasing the Left Ventricular Assist Device (LVAD) heart pump speed. Each time the pump speed is increased, images and measurements are taken. This is called a ramp test.
The ramp testing may also be performed during a right heart catheterization procedure. In a catheterization procedure, a doctor inserts a thin, flexible tube (catheter) into a vein or artery in the upper leg (groin), arm or neck and guides it to the heart using X-ray imaging. Doctors normally perform this procedure to measure the pressure and blood flow in the heart (otherwise called hemodynamic measurements). If the ramp testing is performed during this procedure, then the doctors have additional measurements to consider before choosing a final speed for the Left Ventricular Assist Device (LVAD) pump and appropriate medical treatment.
All of the procedures in this study are considered standard of care. The research part is randomly assigning the subject to one of the two methods of testing in this study. Subjects have a 50/50 chance of being in either testing group.
Baseline Visit (1 - 3 months after Left Ventricular Assist Device (LVAD) implant)
The following will be performed:
- Subjects will be asked to sign this consent form.
- Physical exam with an assessment of heart failure symptoms, and medical history will be recorded
- Routine blood tests (about 1 tablespoon will be drawn)
- Subjects will be randomly assigned to one of the two testing groups. If there is time, the ramp test can be performed at this visit, but usually it will be scheduled to occur a different day in about 1 to 4 weeks.
- 6 Minute Walk Test. This test measures how far the subject can walk in 6 minutes. If needed, this can be completed the day of the ramp test.
- Subjects will be asked to complete a questionnaire about their current quality of life. This will take about 10 minutes. If needed, this can be completed the day of the ramp test.
Ramp Testing Groups:
- Echo Guided Testing - This testing uses echocardiography to create images of the heart and make measurements while gradually increasing the heart pump speed. The final pump speed and medical treatment are determined using the echo measurements. This will take about 45 minutes. OR
- Hemodynamic-Echo Ramp Testing - This testing is performed during a right heart catheterization procedure which provides hemodynamic measurements (pressure and blood flow) in addition to the echocardiography measurements. With this method, more echo images and measurements are taken. The final pump speed and medical treatment adjustments are made using the hemodynamic measurements as well as the information from the echo. This test will take about 1 hour and 45 minutes.
6 Months after Baseline Visit
The following will be performed:
- Physical exam with an assessment of heart failure symptoms, and medical history will be recorded
- Routine blood tests (about 1 tablespoon will be drawn)
- 6 Minute Walk Test. This test measures how far the subject can walk in 6 minutes.
- Subjects will be asked to complete a questionnaire about their current quality of life. This will take about 10 minutes.
- All subjects will undergo a Hemodynamic-Echo Ramp Test at 6 months after the baseline visit.
- Conditions
- Continous Flow Left Ventricular Device
- Being tested
- Echo Guided Testing, Hemodynamic-Echo Ramp Testing -
- Keywords
- Ramp Test, Continuous Flow -Left Ventricular Assist Device (CF-LVAD), LVAD Hemodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echo Guided TestingProcedure or surgery
Hemodynamic-Echo Ramp Testing -Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 1) Echo Guided Testing - | Active comparator | This testing uses echocardiography to create images of the heart and make measurements while gradually increasing the heart pump speed. The final pump speed and medical treatment are determined using the echo measurements. This will take about 45 minutes. Receives: Procedure: Hemodynamic-Echo Ramp Testing - |
| 2) Hemodynamic-Echo Ramp Testing - | Active comparator | This testing is performed during a right heart catheterization procedure which provides hemodynamic measurements (pressure and blood flow) in addition to the echocardiography measurements. With this method, more echo images and measurements are taken. The final pump speed and medical treatment adjustments are made using the hemodynamic measurements as well as the information from the echo. This test will take about 1 hour and 45 minutes. Receives: Procedure: Echo Guided Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical parameters most likely to be impacted by hemodynamic-echo ramp tests
6 Walk Test
Measured: 6 Months
Heart Failure Readmission
Composite end-point of heart failure readmission.
Measured: 6 Months
Quality of Life: Kansas City Cardiomyopathy Questionnaire (KCCQ)
Kansas City Cardiomyopathy Questionnaire (KCCQ) a summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains in which scores are transformed to a range of 0-100.
Measured: 6 Months
New York Heart Association (NYHA) Class
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study startMar 2016
- Primary completionApr 2019
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Continous Flow Left Ventricular DeviceStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03021239
- Sponsor's protocol ID
- IRB15-1733
- Acronym
- Ramp-it-Up
- Status last verified
- Apr 2019
- First submitted
- 3 Jan 2017
- Last updated
- 10 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Uriel N, Burkhoff D, Rich JD, Drakos SG, Teuteberg JJ, Imamura T, Rodgers D, Raikhelkar J, Vorovich EE, Selzman CH, Kim G, Sayer G. Impact of Hemodynamic Ramp Test-Guided HVAD Speed and Medication Adjustments on Clinical Outcomes. Circ Heart Fail. 2019 Apr;12(4):e006067. doi: 10.1161/CIRCHEARTFAILURE.119.006067.
PubMed 30946600
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Hemodynamic Ramp Test-Guided HVAD RPM and Medication Adjustments on Exercise Tolerance and Quality of Life: A Multicenter Study
- ClinicalTrials.gov ID
- NCT03021239
- Acronym / sponsor ID
- Ramp-it-Up / IRB15-1733
- Conditions
- Continous Flow Left Ventricular Device
- Keywords
- Ramp Test, Continuous Flow -Left Ventricular Assist Device (CF-LVAD), LVAD Hemodynamics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Apr 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 13 Jan 2017 (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.
The main purpose of this study is to compare Echo-guided testing to the Hemodynamic-Echo Ramp Tests to determine which method of testing provides better information for adjusting pump speed and medical treatment for Left Ventricular Assist Device (LVAD) patients. Better adjustments may provide better quality of life, exercise tolerance and reduced unwanted cardiac events over a 6-month period.
Detailed description
All Left Ventricular Assist Device (LVAD)patients undergo testing to determine the best pumping speed for their Left Ventricular Assist Device (LVAD) and to gather measurements that help guide medical treatment. The testing uses echocardiography ("echo", ultrasound images of the heart) to create heart images and make measurements while gradually increasing the Left Ventricular Assist Device (LVAD) heart pump speed. Each time the pump speed is increased, images and measurements are taken. This is called a ramp test.
The ramp testing may also be performed during a right heart catheterization procedure. In a catheterization procedure, a doctor inserts a thin, flexible tube (catheter) into a vein or artery in the upper leg (groin), arm or neck and guides it to the heart using X-ray imaging. Doctors normally perform this procedure to measure the pressure and blood flow in the heart (otherwise called hemodynamic measurements). If the ramp testing is performed during this procedure, then the doctors have additional measurements to consider before choosing a final speed for the Left Ventricular Assist Device (LVAD) pump and appropriate medical treatment.
All of the procedures in this study are considered standard of care. The research part is randomly assigning the subject to one of the two methods of testing in this study. Subjects have a 50/50 chance of being in either testing group.
Baseline Visit (1 - 3 months after Left Ventricular Assist Device (LVAD) implant)
The following will be performed:
- Subjects will be asked to sign this consent form.
- Physical exam with an assessment of heart failure symptoms, and medical history will be recorded
- Routine blood tests (about 1 tablespoon will be drawn)
- Subjects will be randomly assigned to one of the two testing groups. If there is time, the ramp test can be performed at this visit, but usually it will be scheduled to occur a different day in about 1 to 4 weeks.
- 6 Minute Walk Test. This test measures how far the subject can walk in 6 minutes. If needed, this can be completed the day of the ramp test.
- Subjects will be asked to complete a questionnaire about their current quality of life. This will take about 10 minutes. If needed, this can be completed the day of the ramp test.
Ramp Testing Groups:
- Echo Guided Testing - This testing uses echocardiography to create images of the heart and make measurements while gradually increasing the heart pump speed. The final pump speed and medical treatment are determined using the echo measurements. This will take about 45 minutes. OR
- Hemodynamic-Echo Ramp Testing - This testing is performed during a right heart catheterization procedure which provides hemodynamic measurements (pressure and blood flow) in addition to the echocardiography measurements. With this method, more echo images and measurements are taken. The final pump speed and medical treatment adjustments are made using the hemodynamic measurements as well as the information from the echo. This test will take about 1 hour and 45 minutes.
6 Months after Baseline Visit
The following will be performed:
- Physical exam with an assessment of heart failure symptoms, and medical history will be recorded
- Routine blood tests (about 1 tablespoon will be drawn)
- 6 Minute Walk Test. This test measures how far the subject can walk in 6 minutes.
- Subjects will be asked to complete a questionnaire about their current quality of life. This will take about 10 minutes.
- All subjects will undergo a Hemodynamic-Echo Ramp Test at 6 months after the baseline visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1) Echo Guided Testing - | Active comparator | Procedure: Hemodynamic-Echo Ramp Testing -This testing uses echocardiography to create images of the heart and make measurements while gradually increasing the heart pump speed. The final pump speed and medical treatment are determined using the echo measurements. This will take about 45 minutes. |
| 2) Hemodynamic-Echo Ramp Testing - | Active comparator | Procedure: Echo Guided TestingThis testing is performed during a right heart catheterization procedure which provides hemodynamic measurements (pressure and blood flow) in addition to the echocardiography measurements. With this method, more echo images and measurements are taken. The final pump speed and medical treatment adjustments are made using the hemodynamic measurements as well as the information from the echo. This test will take about 1 hour and 45 minutes. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient older than 18 years
- Newly implanted HVAD
- HVAD support anticipated for at least 6 months
- Patient is ambulatory and discharged from hospital without inotropes
- Patient is between 1 and 3 months post implant
Key exclusion criteria (4 listed)
- The current HVAD is a replacement device
- Patients currently has Right Ventricle (RV) failure requiring home inotropes
- Inability to preformed right heart cath
- Inadequate echocardiographic windows
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 |
|---|---|---|
| Echo Guided Testing | Procedure or surgery | 2) Hemodynamic-Echo Ramp Testing - |
| Hemodynamic-Echo Ramp Testing - | Procedure or surgery | 1) Echo Guided Testing - |
Primary outcome
Clinical parameters most likely to be impacted by hemodynamic-echo ramp tests
Time frame: 6 Months
6 Walk Test
Heart Failure Readmission
Time frame: 6 Months
Composite end-point of heart failure readmission.
Quality of Life: Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: 6 Months
Kansas City Cardiomyopathy Questionnaire (KCCQ) a summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains in which scores are transformed to a range of 0-100.
New York Heart Association (NYHA) Class
Time frame: 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
- Derived from this study: PubMed 30946600Uriel N, Burkhoff D, Rich JD, Drakos SG, Teuteberg JJ, Imamura T, Rodgers D, Raikhelkar J, Vorovich EE, Selzman CH, Kim G, Sayer G. Impact of Hemodynamic Ramp Test-Guided HVAD Speed and Medication Adjustments on Clinical Outcomes. Circ Heart Fail. 2019 Apr;12(4):e006067. doi: 10.1161/CIRCHEARTFAILURE.119.006067.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Echo Guided Testing and Hemodynamic-Echo Ramp Testing - in people with Continous Flow Left Ventricular Device, run by University of Chicago at 8 sites 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical parameters most likely to be impacted by hemodynamic-echo ramp tests (time frame: 6 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03021239, which also lists 1 linked publication.
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 10 Apr 2019.