Heart Failure, Left-SidedECOH3NCT03087669
Central and Cerebral Circulation in Early Stages After LVAD Implantation
A study testing LVAD flow velocity setting-Rounds per Minute(RPM) on HeartMate III® and MAP intervention using Noradrenalin in people with Heart Failure, Left-Sided and Heart Failure, Right-Sided, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
This trial will evaluate patients with a mechanical Left Ventricular Assist Device (LVAD) in early stages after surgical implantation. Within the first 2 days of postoperative ICU care, 20 patients will firstly be exposed to 4 different LVAD pump flow settings with a stable blood pressure. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure, Left-Sided, Heart Failure, Right-Sided
- What is being tested?
- LVAD flow velocity setting-Rounds per Minute(RPM) on HeartMate III® and MAP intervention using Noradrenalin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- 16 Feb 2017to 1 Mar 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients receiving LVAD of the type HeartMate3® at Sahlgrenska University hospital
Who cannot join
- Perioperative need for an RVAD first 3 days postoperatively after an LVAD implantation
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska University Hospital. Department of Cardiothoracic Anaesthesia & Intensive Care
Gothenburg, 41345
Bjorn Reinsfelt, PhD, 0046313428183, bjorn.reinsfelt@gu.se
Bengt Redfors, PhD, 0046313427445, bengt.redfors@vgregion.se
About this study
Official title: Evaluation of Central and Cerebral Circulation in Early Stages After Implantation of Left Ventricular Assist Device (LVAD)
This trial will evaluate patients with a mechanical Left Ventricular Assist Device (LVAD) in early stages after surgical implantation. Within the first 2 days of postoperative ICU care, 20 patients will firstly be exposed to 4 different LVAD pump flow settings with a stable blood pressure. A second intervention will be mean arterial blood pressure (MAP) adjustments to 4 preset levels (60-70-80 and 90 mmHg) with a constant preset LVAD flow. The two manipulations; 1) Constant MAP with variation of LVAD flow and 2) Constant LVAD flow with variation of MAP, will be monitored by Central hemodynamic parameters, echocardiographic parameters and cerebral blood flow velocity (CBFV) parameters. The purpose of the trial is to find the optimal combination of LVAD pump flow, mean arterial pressure and right heart ventricle function for each patient. And at the same time describe the effect of flow and pressure variations on CBFV.
Read the detailed description
Patients with severe left ventricular heart failure and estimated short expected survival time despite optimal medical therapy can be treated with a left ventricular mechanical heart pump - described as a Left Ventricular Assist Device (LVAD). The LVAD can be used as a bridge for patient survival prior to heart transplantation, or as a destination therapy for terminal heart failure. The LVAD delivers a non-pulsatile blood flow into the patients aorta, supporting and/or taking over the left ventricular function. However the right heart ventricle (RV) is not supported by the LVAD. RV failure is a major threat to the patient, in particular during the early postoperative period. Postoperative RV failure after LVAD implantation is medically treated, but in severe cases a mechanical temporary right ventricular assist (RVAD) may be needed. Patients in need of postoperative RVAD after an LVAD implant have a significantly increased mortality. Thus it is of vital importance to balance the LVAD pump flow against the native RV function in order to avoid the need for an RVAD. If the LVAD flow rate is set too low the RV will be exposed to a high afterload and risk failure. If, on the other hand, the LVAD flow is set too high it can potentially completely empty the left ventricle with secondary geometrical distortion of the heart chambers and an increased venous return to the RV. This too increases the risk for RV failure. To find the optimal LVAD flow rate it is custom to do an extensive evaluation of central hemodynamic parameters (Cardiac Output(CO), Pulmonary Capillary Wedge Pressure (PCWP), Pulmonary Arterial Pressure (PAP), Central Venous Pressure (CVP)) and cardiac echocardiographic evaluation of RV function at different LVAD pump flow rates and MAP. The instant balance between RV filling pressure-CVP, and LV filling pressure-PCWP, is on the other hand easy to obtain. However it is not known if these measurements can be used to obtain an optimal LVAD flow rate. Furthermore all mechanically driven circulatory support devices, including LVAD, will expose the peripheral arterial circulation to a non-pulsatile blood flow.There are few previous reports on how an LVAD affects the cerebral blood flow autoregulation and microembolic load at different settings and MAP. This investigation aims to describe these cerebral effect af an LVAD using a continous Transcranial Doppler (TCD) detection of cerebral arteries.
- Being tested
- LVAD flow velocity setting-Rounds per Minute(RPM) on HeartMate III®, MAP intervention using Noradrenalin
- Keywords
- Left Ventricular Assist Device, Hemodynamic monitoring
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LVAD flow velocity setting-Rounds per Minute(RPM) on HeartMate III®Device
Also called RPM setting
Increase in LVAD RPM setting induces an actual increase in LVAD outflow to the patient.This gives the patient an increased systemic Cardiac Output(CO)
MAP intervention using NoradrenalinDrug
Also called MAP setting
At a fixed RPM rate for the LVAD the Mean Arterial Pressure (MAP) is increased to preset levels of 60-70-80-90 mmHG using Noradrenalin
| Study group | Role | What they receive |
|---|---|---|
| Observation of hemodynamic parameters | Experimental | LVAD flow velocity setting-Rounds Per Minute(RPM) intervention: Change of LVAD RPM while observing Central hemodynamic, echocardiographic and CBFV effects.
MAP intervention: Stepwise Change of MAP from 60-70-80 to 90 mmHg with a fixed set of LVAD RPM. After a 5 minute steady state for each level of MAP, the observations of central hemodynamics, echocardiographic measures and CBFV measurements will be repeated. Receives: Device: LVAD flow velocity setting-Rounds per Minute(RPM) on HeartMate III®; Drug: MAP intervention using Noradrenalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes PCWP/CVP ratio
The change in PCWP (mmHg)/CVP (mmHg) ratio at different levels of LVAD flow as a marker for the optimal balance between LVAD flow and RV function
Measured: Change from baseline at different settings of LVAD RPM within 10 minutes for each level
Secondary outcomes (4)
CO
Cardiac Output in litres/minute
Measured: Change from baseline at different settings of LVAD RPM within 10 minutes for each level
LVAD Velocity Time Integral
LVAD Velocity Time Integral in centimeters(cm)
Measured: Change from baseline at different settings of LVAD RPM within 10 minutes for each level
Right Ventricle Outflow Tract (RVOT) Velocity Time Integral (VTI)
RVOT Velocity Time Integral in centimeters(cm)
Measured: Change from baseline at different settings of LVAD RPM within 10 minutes for each level
CBFV
CBFV in cm/second
Measured: Change from baseline at different settings of LVAD RPM within 10 minutes for each level
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study start16 Feb 2017
- Primary completion1 Mar 2020 (estimated)
- Study completion1 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart Failure, Left-SidedStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- 1. LVAD will have a setting of 4800 rounds per minute (RPM). Hemodynamic, echocardiographic and cerebral blood flow measurements will be performed: CO, PCWP, CVP, PAP, MAP, Peripheral and central hemoglobine oxygen saturation (SaO2 and SvO2), Heart Rate (HR), RV outflow tract Velocity Time Integral (RVOT VTI), RV and LV diameter, VTI of LVAD outflow. CBFV of right and left medial cerebral artery (RMCA and LMCA) 2. The above mentioned measurements will be repeated with LVAD settings of 5200 RPM, 5600 RPM, and 6000 RPM. 3. With the LVAD fixed to an optimized setting detected by the previous interventions, the blood pressure will be adjusted to MAP 60 mmHg. The above mentioned measurements will be repeated. 4. Using Noradrenaline the MAP will be adjusted to 70mmHg, 80 mmHg and 90 mmHg. At steady state for each level of MAP with a fixed LVAD flow, all the above mentioned measurements will be repeatedly performed.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bjorn Reinsfelt, Sahlgrenska University Hospital
- Investigators
- Sven Erik Ricksten, MD.PhD, Study director, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03087669
- Sponsor's protocol ID
- ECOH 3
- Acronym
- ECOH3
- Status last verified
- Mar 2017
- First submitted
- 28 Feb 2017
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Uriel N, Adatya S, Maly J, Kruse E, Rodgers D, Heatley G, Herman A, Sood P, Berliner D, Bauersachs J, Haverich A, Zelizko M, Schmitto JD, Netuka I. Clinical hemodynamic evaluation of patients implanted with a fully magnetically levitated left ventricular assist device (HeartMate 3). J Heart Lung Transplant. 2017 Jan;36(1):28-35. doi: 10.1016/j.healun.2016.07.008. Epub 2016 Jul 17.
PubMed 27773456Uriel N, Sayer G, Addetia K, Fedson S, Kim GH, Rodgers D, Kruse E, Collins K, Adatya S, Sarswat N, Jorde UP, Juricek C, Ota T, Jeevanandam V, Burkhoff D, Lang RM. Hemodynamic Ramp Tests in Patients With Left Ventricular Assist Devices. JACC Heart Fail. 2016 Mar;4(3):208-17. doi: 10.1016/j.jchf.2015.10.001. Epub 2015 Dec 30.
PubMed 26746378Ono M, Joshi B, Brady K, Easley RB, Kibler K, Conte J, Shah A, Russell SD, Hogue CW. Cerebral blood flow autoregulation is preserved after continuous-flow left ventricular assist device implantation. J Cardiothorac Vasc Anesth. 2012 Dec;26(6):1022-8. doi: 10.1053/j.jvca.2012.07.014.
PubMed 23122299
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Central and Cerebral Circulation in Early Stages After Implantation of Left Ventricular Assist Device (LVAD)
- ClinicalTrials.gov ID
- NCT03087669
- Acronym / sponsor ID
- ECOH3 / ECOH 3
- Keywords
- Left Ventricular Assist Device, Hemodynamic monitoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 16 Feb 2017 (actual)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 22 Mar 2017 (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.
This trial will evaluate patients with a mechanical Left Ventricular Assist Device (LVAD) in early stages after surgical implantation. Within the first 2 days of postoperative ICU care, 20 patients will firstly be exposed to 4 different LVAD pump flow settings with a stable blood pressure. A second intervention will be mean arterial blood pressure (MAP) adjustments to 4 preset levels (60-70-80 and 90 mmHg) with a constant preset LVAD flow. The two manipulations; 1) Constant MAP with variation of LVAD flow and 2) Constant LVAD flow with variation of MAP, will be monitored by Central hemodynamic parameters, echocardiographic parameters and cerebral blood flow velocity (CBFV) parameters. The purpose of the trial is to find the optimal combination of LVAD pump flow, mean arterial pressure and right heart ventricle function for each patient. And at the same time describe the effect of flow and pressure variations on CBFV.
Detailed description
Patients with severe left ventricular heart failure and estimated short expected survival time despite optimal medical therapy can be treated with a left ventricular mechanical heart pump - described as a Left Ventricular Assist Device (LVAD). The LVAD can be used as a bridge for patient survival prior to heart transplantation, or as a destination therapy for terminal heart failure. The LVAD delivers a non-pulsatile blood flow into the patients aorta, supporting and/or taking over the left ventricular function. However the right heart ventricle (RV) is not supported by the LVAD. RV failure is a major threat to the patient, in particular during the early postoperative period. Postoperative RV failure after LVAD implantation is medically treated, but in severe cases a mechanical temporary right ventricular assist (RVAD) may be needed. Patients in need of postoperative RVAD after an LVAD implant have a significantly increased mortality. Thus it is of vital importance to balance the LVAD pump flow against the native RV function in order to avoid the need for an RVAD. If the LVAD flow rate is set too low the RV will be exposed to a high afterload and risk failure. If, on the other hand, the LVAD flow is set too high it can potentially completely empty the left ventricle with secondary geometrical distortion of the heart chambers and an increased venous return to the RV. This too increases the risk for RV failure. To find the optimal LVAD flow rate it is custom to do an extensive evaluation of central hemodynamic parameters (Cardiac Output(CO), Pulmonary Capillary Wedge Pressure (PCWP), Pulmonary Arterial Pressure (PAP), Central Venous Pressure (CVP)) and cardiac echocardiographic evaluation of RV function at different LVAD pump flow rates and MAP. The instant balance between RV filling pressure-CVP, and LV filling pressure-PCWP, is on the other hand easy to obtain. However it is not known if these measurements can be used to obtain an optimal LVAD flow rate. Furthermore all mechanically driven circulatory support devices, including LVAD, will expose the peripheral arterial circulation to a non-pulsatile blood flow.There are few previous reports on how an LVAD affects the cerebral blood flow autoregulation and microembolic load at different settings and MAP. This investigation aims to describe these cerebral effect af an LVAD using a continous Transcranial Doppler (TCD) detection of cerebral arteries.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 1. LVAD will have a setting of 4800 rounds per minute (RPM). Hemodynamic, echocardiographic and cerebral blood flow measurements will be performed: CO, PCWP, CVP, PAP, MAP, Peripheral and central hemoglobine oxygen saturation (SaO2 and SvO2), Heart Rate (HR), RV outflow tract Velocity Time Integral (RVOT VTI), RV and LV diameter, VTI of LVAD outflow. CBFV of right and left medial cerebral artery (RMCA and LMCA) 2. The above mentioned measurements will be repeated with LVAD settings of 5200 RPM, 5600 RPM, and 6000 RPM. 3. With the LVAD fixed to an optimized setting detected by the previous interventions, the blood pressure will be adjusted to MAP 60 mmHg. The above mentioned measurements will be repeated. 4. Using Noradrenaline the MAP will be adjusted to 70mmHg, 80 mmHg and 90 mmHg. At steady state for each level of MAP with a fixed LVAD flow, all the above mentioned measurements will be repeatedly performed.
| Arm | Type | Receives |
|---|---|---|
| Observation of hemodynamic parameters | Experimental | Device: LVAD flow velocity setting-Rounds per Minute(RPM) on HeartMate III®, Drug: MAP intervention using NoradrenalinLVAD flow velocity setting-Rounds Per Minute(RPM) intervention: Change of LVAD RPM while observing Central hemodynamic, echocardiographic and CBFV effects. MAP intervention: Stepwise Change of MAP from 60-70-80 to 90 mmHg with a fixed set of LVAD RPM. After a 5 minute steady state for each level of MAP, the observations of central hemodynamics, echocardiographic measures and CBFV measurements will be repeated. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients receiving LVAD of the type HeartMate3® at Sahlgrenska University hospital
Key exclusion criteria (1 listed)
- Perioperative need for an RVAD first 3 days postoperatively after an LVAD implantation
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 |
|---|---|---|
| LVAD flow velocity setting-Rounds per Minute(RPM) on HeartMate III®Also: RPM settingIncrease in LVAD RPM setting induces an actual increase in LVAD outflow to the patient.This gives the patient an increased systemic Cardiac Output(CO) | Device | Observation of hemodynamic parameters |
| MAP intervention using NoradrenalinAlso: MAP settingAt a fixed RPM rate for the LVAD the Mean Arterial Pressure (MAP) is increased to preset levels of 60-70-80-90 mmHG using Noradrenalin | Drug | Observation of hemodynamic parameters |
Primary outcome
Changes PCWP/CVP ratio
Time frame: Change from baseline at different settings of LVAD RPM within 10 minutes for each level
The change in PCWP (mmHg)/CVP (mmHg) ratio at different levels of LVAD flow as a marker for the optimal balance between LVAD flow and RV function
4 secondary outcomes
CO
Time frame: Change from baseline at different settings of LVAD RPM within 10 minutes for each level
LVAD Velocity Time Integral
Time frame: Change from baseline at different settings of LVAD RPM within 10 minutes for each level
Right Ventricle Outflow Tract (RVOT) Velocity Time Integral (VTI)
Time frame: Change from baseline at different settings of LVAD RPM within 10 minutes for each level
CBFV
Time frame: Change from baseline at different settings of LVAD RPM within 10 minutes for each level
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2017.
- Results publication: PubMed 27773456Uriel N, Adatya S, Maly J, Kruse E, Rodgers D, Heatley G, Herman A, Sood P, Berliner D, Bauersachs J, Haverich A, Zelizko M, Schmitto JD, Netuka I. Clinical hemodynamic evaluation of patients implanted with a fully magnetically levitated left ventricular assist device (HeartMate 3). J Heart Lung Transplant. 2017 Jan;36(1):28-35. doi: 10.1016/j.healun.2016.07.008. Epub 2016 Jul 17.
- Results publication: PubMed 26746378Uriel N, Sayer G, Addetia K, Fedson S, Kim GH, Rodgers D, Kruse E, Collins K, Adatya S, Sarswat N, Jorde UP, Juricek C, Ota T, Jeevanandam V, Burkhoff D, Lang RM. Hemodynamic Ramp Tests in Patients With Left Ventricular Assist Devices. JACC Heart Fail. 2016 Mar;4(3):208-17. doi: 10.1016/j.jchf.2015.10.001. Epub 2015 Dec 30.
- Results publication: PubMed 23122299Ono M, Joshi B, Brady K, Easley RB, Kibler K, Conte J, Shah A, Russell SD, Hogue CW. Cerebral blood flow autoregulation is preserved after continuous-flow left ventricular assist device implantation. J Cardiothorac Vasc Anesth. 2012 Dec;26(6):1022-8. doi: 10.1053/j.jvca.2012.07.014.
- 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.
Sven Erik Ricksten, MD.PhD study director
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LVAD flow velocity setting-Rounds per Minute(RPM) on HeartMate III® and MAP intervention using Noradrenalin in people with Heart Failure, Left-Sided and Heart Failure, Right-Sided, run by Sahlgrenska University Hospital at 1 site in Sweden.
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 1 inclusion and 1 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 22 Mar 2017. 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 Sweden. 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 Bengt Redfors, MD.PhD (0046313427445, bengt.redfors@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes PCWP/CVP ratio (time frame: Change from baseline at different settings of LVAD RPM within 10 minutes for each level). 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 NCT03087669, which also lists 3 linked publications.
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 22 Mar 2017.