Right Heart FailureEuroEchoVADNCT03552679
Serial Multiparametric Evaluation of Right Ventricular Function After Left Ventricular Assist Device Implantation
An observational study of Right Heart Failure, run by Erasmus Medical Center at 9 sites in 7 countries.
Trial summary
The primary purpose of this study is to investigate the evolution of Right Ventricular (RV) function before and after left ventricular assist device (LVAD) implantation, using novel echocardiographic quantification of RV size and function in combination with comprehensive hemodynamic, laboratory and clinical… Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Right Heart Failure
- What is being tested?
- Echocardiography
- How many people
- 600 participants
- Where
- 9 sitesin 7 countries
- Study dates
- 24 Jun 2018to Jul 2021
- How long will I take part?
- 12 Months
- 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 17 years and older
- All sexes
- Child, Adult, Older adult
Study population: Consecutive patients who underwent LVAD implantation using main stream devices
Who may be able to join
- Subjects to be included in the study must meet the following inclusion criteria:
- Consecutive patients accepted for elective LVAD implantation in the context of routine care
- >17 years of age
- Written informed consent (IC), either by the patient or by legal representatives
- Treated with mainstream devices
Who cannot join
- None
Trial locations and contacts
9 sites in 7 countries.
9 sites in 7 countries
Germany2 sites, 2 recruiting
- Not yet recruiting
Herz- und Diabeteszentrum Nordrhein- Westfalen
Bad Oeynhausen
Lech Paluszkiewicz, MD, PhD
Lech Paluszkiewicz, MD, PhD
- Not yet recruiting
Deutsches Herzzentrum Berlin
Berlin
Felix Schönrath, MD, PhD
Felix Schönrath, MD, PhD
Italy2 sites, 2 recruiting
- Recruiting
S. Orsola Hospital, Bologna University
Bologna
Antonio Loforte, MD, PHD
Antonio Loforte
- Not yet recruiting
Ospedale dei Colli
Naples
Cristiano Amarelli
Cristiano Amarelli, MD, PhD
Hungary1 site, 1 recruiting
- Not yet recruiting
Heart Center of the Semmelweis University
Budapest
Béla Merkely, MD, PhD
Béla Merkely, MD, PhD
Kazakhstan1 site, 1 recruiting
- Not yet recruiting
National Research Cardiac Surgery Center
Astana
Makhabbat Bekbossynova, MD, PhD
Makhabbat Bekbossynova, MD, PhD
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus Medical Center
Rotterdam
Kadir Caliskan, MD, PhD
Kadir Caliskan, MD, PhD
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ege University School of Medicine
Izmir
Sanem Nalbantgil, MD, PhD
Sanem Nalbantgil, MD, PhD
About this study
Official title: A Prospective, Multicenter, Observational, Investigator Initiated Study, Aiming at Serial Multiparametric Evaluation of Right Ventricular Function to Predict Optimal Management Strategies, of Right Heart Failure After LVAD Implantation
The primary purpose of this study is to investigate the evolution of Right Ventricular (RV) function before and after left ventricular assist device (LVAD) implantation, using novel echocardiographic quantification of RV size and function in combination with comprehensive hemodynamic, laboratory and clinical parameters. The findings of the study will enhance prediction of early and late development of postoperative right-sided heart failure (RHF) and subsequent mortality and morbidity.
The secondary purpose of the study is to combine echocardiographic, hemodynamic, laboratory, and clinical data to define optimal management strategies of RHF after LVAD implantation.
Read the detailed description
The study consists of 2 parts: a Pilot study and a Main Study as detailed below.
The purpose of the Pilot study is to evaluate the feasibility of RV quantification using two-, three-dimensional and Multiplane echocardiography.
About 100 subjects undergoing LVAD implantation in the European Registry for Patients with Mechanical Circulatory Support (EUROMACS) Registry are included in the Pilot study. These 100 patients will undergo routinely scheduled echocardiography before, within 1 week, 3 months and 1 year after LVAD implantation. Echocardiography will be performed using ultrasound machines that are capable of acquisition of two-, three-dimensional and Multiplane Echocardiography of the right ventricle.
Echocardiographic analysis will include three-dimensional quantification of the RV size and function as well as RV strain analysis in the Multiplane format as described in the Appendix Echocardiography Procedure Manual.
The Echocardiographic analyses of the first 50 patients, included in selected sites, will be used to further specify the protocol for image acquisition and analysis to be used in the Main Study. Furthermore, all sites will first enter 2 patients in the Pilot Study before they can participate in the Main Study. The echocardiographic results of these 2 patients will be assessed by the core lab for quality.
The purpose of the Main Study is to assess the evolution of RV function before and after LVAD implantation utilizing the acquisition and analysis protocol developed in the Pilot Study.
500 patients will undergo routinely scheduled echocardiographic imaging before LVAD implantation, and at 1 week, 1 month, 3 months, 6 months and 1 year thereafter. Echocardiography will be performed using the detailed protocol developed in the Pilot Study. All Echocardiographic images will be submitted to an independent Core Laboratory for analysis.
The evolution of RV function will be documented with standardised two-, three-dimensional and Multiplane Echocardiography of the right ventricle. The echocardiographic parameters include: RV strain and strain rate, RV Fractional Area Change, RV longitudinal function, RV volumes, RV ejection fraction, tricuspid regurgitation severity, estimated pulmonary artery pressures, pulmonary artery resistance, pulmonary artery compliance, RV stroke work index, right atrial size, and RV - pulmonary coupling.
Invasive hemodynamic data will be collected in the perioperative period. These RV parameters will be linked to the occurrence of clinical signs, hemodynamic and laboratory evidence of RHF.
- Conditions
- Right Heart Failure
- Being tested
- Echocardiography
- Keywords
- Right Heart Failure, Ventricular Assist Device, Mortality, ICU Stay, Acute Kidney Injury
- Medical subject headings
- Heart Failure, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyDiagnostic test
Echocardiography
| Study group | Role | What they receive |
|---|---|---|
| LVAD recipients | Consecutive patients accepted for elective LVAD implantation in the context of routine care, will undergo routinely scheduled echocardiography before, within 1 week, 1 month, 3 months and 1 year after LVAD implantation. Echocardiography will be performed using ultrasound machines that are capable of acquisition of two-, three-dimensional and Multiplane Echocardiography of the right ventricle. Invasive hemodynamic data will be collected in the perioperative period. Receives: Diagnostic Test: Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Moderate or severe RHF
RHF is defined by a triad of:
- Clinical (right-sided congestion, with or without hypotension, or hypo-perfusion)
- Imaging evidence (RV dilatation, new > grade 2 tricuspid regurgitation) deterioration right ventricular function score assessed by the echocardiography core laboratory)
- Hemodynamic evidence (discordant elevated central venous pressure (CVP) or right atrial pressure (RAP) >16 mmHg, despite normal or steady pulmonary capillary wedge pressure (PCWP), or right atrial (RA) to PCWP ratio >0.54).
Measured: 12 months
Secondary outcomes (20)
Severe RHF composite
The occurrence of Severe RHF composite after LVAD implantation
Measured: 1 week, 30 days, 90 days, 180 days, 12 months
All-cause death
The occurrence of all-cause death after LVAD implantation
Measured: 1 week, 30 days, 90 days, 180 days, 12 months
Cardiovascular death
The occurrence of cardiovascular death after LVAD implantation
Measured: 1 week, 30 days, 90 days, 180 days, 12 months
Death or urgent transplantation
The occurrence of death or urgent transplantation after LVAD implantation
Measured: 1 week, 30 days, 90 days, 180 days, 12 months
Length of post-operative Intensive Care Unit (ICU) stay
The length of post-operative ICU stay in days after LVAD implantation
Measured: 30 days, 90 days, 180 days, 12 months
Length of post-operative hospital stay
The length of post-operative hospital stay in days after LVAD implantation
Measured: 30 days, 90 days, 180 days, 12 months
Readmissions for heart failure or RHF
The occurrence of hospital readmissions for heart failure or RHF after LVAD implantation
Measured: 30 days, 90 days, 180 days, 12 months
Sepsis
The occurrence of sepsis after LVAD implantation
Measured: 1 week, 30 days, 90 days, 180 days, 12 months
LVAD and driveline-related infection
The occurrence of LVAD and driveline-related infection after LVAD implantation
Measured: 1 week, 30 days, 90 days, 180 days, 12 months
Early and late bleeding complications
The occurrence of LVAD and driveline-related infection after LVAD implantation
Measured: 1 week, 30 days, 90 days, 180 days, 12 months
LVAD pump thrombosis
The occurrence of LVAD and driveline-related infection after LVAD implantation
Measured: 1 week, 30 days, 90 days, 180 days, 12 months
Haemolysis
The occurrence of LVAD and driveline-related infection after LVAD implantation
Measured: 1 week, 30 days, 90 days, 180 days, 12 months
Arterial thromboembolic events, including stroke
The occurrence of LVAD and driveline-related infection after LVAD implantation
Measured: 1 week, 30 days, 90 days, 180 days, 12 months
Venous thromboembolic events, including deep venous thrombosis (DVT) and pulmonary embolism (PE)
The occurrence of LVAD and driveline-related infection after LVAD implantation
Measured: 1 week, 30 days, 90 days, 180 days, 12 months
Ventricular arrhythmias, either sustained symptomatic or with appropriate Implantable Cardioverter Defibrillator (ICD) therapy
The occurrence of LVAD and driveline-related infection after LVAD implantation
Measured: 1 week, 30 days, 90 days, 180 days, 12 months
Atrial arrhythmias - documented atrial flutter or fibrillation
The occurrence of LVAD and driveline-related infection after LVAD implantation
Measured: 1 week, 30 days, 90 days, 180 days, 12 months
Acute Kidney Injury (AKI) according to Kidney Disease Outcomes Quality Initiative (KDIGO) and RIFFLE criteria
The occurrence of LVAD and driveline-related infection after LVAD implantation
Measured: 1 week, 30 days, 90 days, 180 days, 12 months
Chronic kidney disease (CKD) according to KDOQI criteria
The occurrence of Chronic kidney disease (CKD) according to KDOQI criteria after LVAD implantation
Measured: 1 week, 30 days, 90 days, 180 days, 12 months
Six Minute walk distance in meters
Assessment of Six Minute walk distance in meters before and after LVAD implantation
Measured: 90 days and 12 months
Quality of life (QoL) scores
QoL by multiple assessments before and at 90 days, 180 days and at 12 months after LVAD implantation at
Measured: 90 days, 180 days and at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study start24 Jun 2018
- Primary completionFeb 2021 (estimated)
- Study completionJul 2021 (estimated)
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 Right Heart FailureStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- The European Association for Cardio-Thoracic Surgery
- Responsible party
- Principal investigator, I. Osama SOLIMAN, Erasmus Medical Center
- Investigators
- Osama SOLIMAN, MD, PhD, Principal investigator, Euro Heart FoundationKadir Caliskan, MD, PhD, Principal investigator, Erasmus MC Rotterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03552679
- Sponsor's protocol ID
- WT/aj/MEC-2018-1162
- Acronym
- EuroEchoVAD
- Status last verified
- Oct 2019
- First submitted
- 27 May 2018
- Last updated
- 11 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Soliman OII, Akin S, Muslem R, Boersma E, Manintveld OC, Krabatsch T, Gummert JF, de By TMMH, Bogers AJJC, Zijlstra F, Mohacsi P, Caliskan K; EUROMACS Investigators. Derivation and Validation of a Novel Right-Sided Heart Failure Model After Implantation of Continuous Flow Left Ventricular Assist Devices: The EUROMACS (European Registry for Patients with Mechanical Circulatory Support) Right-Sided Heart Failure Risk Score. Circulation. 2018 Feb 27;137(9):891-906. doi: 10.1161/CIRCULATIONAHA.117.030543. Epub 2017 Aug 27.
PubMed 28847897
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Observational, Investigator Initiated Study, Aiming at Serial Multiparametric Evaluation of Right Ventricular Function to Predict Optimal Management Strategies, of Right Heart Failure After LVAD Implantation
- ClinicalTrials.gov ID
- NCT03552679
- Acronym / sponsor ID
- EuroEchoVAD / WT/aj/MEC-2018-1162
- Conditions
- Right Heart Failure
- Keywords
- Right Heart Failure, Ventricular Assist Device, Mortality, ICU Stay, Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- The European Association for Cardio-Thoracic Surgery
- Study start
- 24 Jun 2018 (actual)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 12 Jun 2018 (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.
The primary purpose of this study is to investigate the evolution of Right Ventricular (RV) function before and after left ventricular assist device (LVAD) implantation, using novel echocardiographic quantification of RV size and function in combination with comprehensive hemodynamic, laboratory and clinical parameters. The findings of the study will enhance prediction of early and late development of postoperative right-sided heart failure (RHF) and subsequent mortality and morbidity.
The secondary purpose of the study is to combine echocardiographic, hemodynamic, laboratory, and clinical data to define optimal management strategies of RHF after LVAD implantation.
Detailed description
The study consists of 2 parts: a Pilot study and a Main Study as detailed below.
The purpose of the Pilot study is to evaluate the feasibility of RV quantification using two-, three-dimensional and Multiplane echocardiography.
About 100 subjects undergoing LVAD implantation in the European Registry for Patients with Mechanical Circulatory Support (EUROMACS) Registry are included in the Pilot study. These 100 patients will undergo routinely scheduled echocardiography before, within 1 week, 3 months and 1 year after LVAD implantation. Echocardiography will be performed using ultrasound machines that are capable of acquisition of two-, three-dimensional and Multiplane Echocardiography of the right ventricle.
Echocardiographic analysis will include three-dimensional quantification of the RV size and function as well as RV strain analysis in the Multiplane format as described in the Appendix Echocardiography Procedure Manual.
The Echocardiographic analyses of the first 50 patients, included in selected sites, will be used to further specify the protocol for image acquisition and analysis to be used in the Main Study. Furthermore, all sites will first enter 2 patients in the Pilot Study before they can participate in the Main Study. The echocardiographic results of these 2 patients will be assessed by the core lab for quality.
The purpose of the Main Study is to assess the evolution of RV function before and after LVAD implantation utilizing the acquisition and analysis protocol developed in the Pilot Study.
500 patients will undergo routinely scheduled echocardiographic imaging before LVAD implantation, and at 1 week, 1 month, 3 months, 6 months and 1 year thereafter. Echocardiography will be performed using the detailed protocol developed in the Pilot Study. All Echocardiographic images will be submitted to an independent Core Laboratory for analysis.
The evolution of RV function will be documented with standardised two-, three-dimensional and Multiplane Echocardiography of the right ventricle. The echocardiographic parameters include: RV strain and strain rate, RV Fractional Area Change, RV longitudinal function, RV volumes, RV ejection fraction, tricuspid regurgitation severity, estimated pulmonary artery pressures, pulmonary artery resistance, pulmonary artery compliance, RV stroke work index, right atrial size, and RV - pulmonary coupling.
Invasive hemodynamic data will be collected in the perioperative period. These RV parameters will be linked to the occurrence of clinical signs, hemodynamic and laboratory evidence of RHF.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LVAD recipients | – | Diagnostic Test: EchocardiographyConsecutive patients accepted for elective LVAD implantation in the context of routine care, will undergo routinely scheduled echocardiography before, within 1 week, 1 month, 3 months and 1 year after LVAD implantation. Echocardiography will be performed using ultrasound machines that are capable of acquisition of two-, three-dimensional and Multiplane Echocardiography of the right ventricle. Invasive hemodynamic data will be collected in the perioperative period. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive patients who underwent LVAD implantation using main stream devices
Key inclusion criteria (5 listed)
- Consecutive patients accepted for elective LVAD implantation in the context of routine care
- >17 years of age
- Written informed consent (IC), either by the patient or by legal representatives
- Treated with mainstream devices
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| EchocardiographyEchocardiography | Diagnostic test | LVAD recipients |
Primary outcome
Moderate or severe RHF
Time frame: 12 months
RHF is defined by a triad of: 1. Clinical (right-sided congestion, with or without hypotension, or hypo-perfusion) 2. Imaging evidence (RV dilatation, new > grade 2 tricuspid regurgitation) deterioration right ventricular function score assessed by the echocardiography core laboratory) 3. Hemodynamic evidence (discordant elevated central venous pressure (CVP) or right atrial pressure (RAP) >16 mmHg, despite normal or steady pulmonary capillary wedge pressure (PCWP), or right atrial (RA) to PCWP ratio >0.54).
20 secondary outcomes
Severe RHF composite
Time frame: 1 week, 30 days, 90 days, 180 days, 12 months
All-cause death
Time frame: 1 week, 30 days, 90 days, 180 days, 12 months
Cardiovascular death
Time frame: 1 week, 30 days, 90 days, 180 days, 12 months
Death or urgent transplantation
Time frame: 1 week, 30 days, 90 days, 180 days, 12 months
Length of post-operative Intensive Care Unit (ICU) stay
Time frame: 30 days, 90 days, 180 days, 12 months
Length of post-operative hospital stay
Time frame: 30 days, 90 days, 180 days, 12 months
Readmissions for heart failure or RHF
Time frame: 30 days, 90 days, 180 days, 12 months
Sepsis
Time frame: 1 week, 30 days, 90 days, 180 days, 12 months
LVAD and driveline-related infection
Time frame: 1 week, 30 days, 90 days, 180 days, 12 months
Early and late bleeding complications
Time frame: 1 week, 30 days, 90 days, 180 days, 12 months
LVAD pump thrombosis
Time frame: 1 week, 30 days, 90 days, 180 days, 12 months
Haemolysis
Time frame: 1 week, 30 days, 90 days, 180 days, 12 months
Arterial thromboembolic events, including stroke
Time frame: 1 week, 30 days, 90 days, 180 days, 12 months
Venous thromboembolic events, including deep venous thrombosis (DVT) and pulmonary embolism (PE)
Time frame: 1 week, 30 days, 90 days, 180 days, 12 months
Ventricular arrhythmias, either sustained symptomatic or with appropriate Implantable Cardioverter Defibrillator (ICD) therapy
Time frame: 1 week, 30 days, 90 days, 180 days, 12 months
Atrial arrhythmias - documented atrial flutter or fibrillation
Time frame: 1 week, 30 days, 90 days, 180 days, 12 months
Acute Kidney Injury (AKI) according to Kidney Disease Outcomes Quality Initiative (KDIGO) and RIFFLE criteria
Time frame: 1 week, 30 days, 90 days, 180 days, 12 months
Chronic kidney disease (CKD) according to KDOQI criteria
Time frame: 1 week, 30 days, 90 days, 180 days, 12 months
Six Minute walk distance in meters
Time frame: 90 days and 12 months
Quality of life (QoL) scores
Time frame: 90 days, 180 days and at 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2019.
- Background: PubMed 28847897Soliman OII, Akin S, Muslem R, Boersma E, Manintveld OC, Krabatsch T, Gummert JF, de By TMMH, Bogers AJJC, Zijlstra F, Mohacsi P, Caliskan K; EUROMACS Investigators. Derivation and Validation of a Novel Right-Sided Heart Failure Model After Implantation of Continuous Flow Left Ventricular Assist Devices: The EUROMACS (European Registry for Patients with Mechanical Circulatory Support) Right-Sided Heart Failure Risk Score. Circulation. 2018 Feb 27;137(9):891-906. doi: 10.1161/CIRCULATIONAHA.117.030543. Epub 2017 Aug 27.
- 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.
Osama SOLIMAN, MD, PhD principal investigator
Euro Heart Foundation
Kadir Caliskan, MD, PhD principal investigator
Erasmus MC Rotterdam
9 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Right Heart Failure, run by Erasmus Medical Center at 9 sites in 7 countries.
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 5 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 11 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany, Italy, Hungary, Kazakhstan, Netherlands and 2 more countries. 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 Osama SOLIMAN, MD, PhD (+31643158470, osoliman@eurohf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Moderate or severe RHF (time frame: 12 months). 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 NCT03552679, 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 11 Oct 2019.