Clinical trial NCT03552679: Serial Multiparametric Evaluation of Right Ventricular Function After Left Ventricular Assist Device Implantation
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Right Heart Failure
Keywords: Right Heart Failure
Ventricular Assist Device
Mortality
ICU Stay
Acute Kidney Injury
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: The European Association for Cardio-Thoracic Surgery
First posted: 2018-06-12
Enrollment: 600
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients who underwent LVAD implantation using main stream devices

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

Subjects to be included in the study must meet the following inclusion criteria:

1. Consecutive patients accepted for elective LVAD implantation in the context of routine care
2. \>17 years of age
3. Written informed consent (IC), either by the patient or by legal representatives
4. Treated with mainstream devices

Exclusion Criteria:

* None

Primary outcomes:
measure: Moderate or severe RHF
timeFrame: 12 months
Secondary outcomes:
measure: Severe RHF composite
timeFrame: 1 week, 30 days, 90 days, 180 days, 12 months
measure: All-cause death
timeFrame: 1 week, 30 days, 90 days, 180 days, 12 months
measure: Cardiovascular death
timeFrame: 1 week, 30 days, 90 days, 180 days, 12 months
measure: Death or urgent transplantation
timeFrame: 1 week, 30 days, 90 days, 180 days, 12 months
measure: Length of post-operative Intensive Care Unit (ICU) stay
timeFrame: 30 days, 90 days, 180 days, 12 months
measure: Length of post-operative hospital stay
timeFrame: 30 days, 90 days, 180 days, 12 months
measure: Readmissions for heart failure or RHF
timeFrame: 30 days, 90 days, 180 days, 12 months
measure: Sepsis
timeFrame: 1 week, 30 days, 90 days, 180 days, 12 months
measure: LVAD and driveline-related infection
timeFrame: 1 week, 30 days, 90 days, 180 days, 12 months
measure: Early and late bleeding complications
timeFrame: 1 week, 30 days, 90 days, 180 days, 12 months
measure: LVAD pump thrombosis
timeFrame: 1 week, 30 days, 90 days, 180 days, 12 months
measure: Haemolysis
timeFrame: 1 week, 30 days, 90 days, 180 days, 12 months
measure: Arterial thromboembolic events, including stroke
timeFrame: 1 week, 30 days, 90 days, 180 days, 12 months
measure: Venous thromboembolic events, including deep venous thrombosis (DVT) and pulmonary embolism (PE)
timeFrame: 1 week, 30 days, 90 days, 180 days, 12 months
measure: Ventricular arrhythmias, either sustained symptomatic or with appropriate Implantable Cardioverter Defibrillator (ICD) therapy
timeFrame: 1 week, 30 days, 90 days, 180 days, 12 months
measure: Atrial arrhythmias - documented atrial flutter or fibrillation
timeFrame: 1 week, 30 days, 90 days, 180 days, 12 months
measure: Acute Kidney Injury (AKI) according to Kidney Disease Outcomes Quality Initiative (KDIGO) and RIFFLE criteria
timeFrame: 1 week, 30 days, 90 days, 180 days, 12 months
measure: Chronic kidney disease (CKD) according to KDOQI criteria
timeFrame: 1 week, 30 days, 90 days, 180 days, 12 months
measure: Six Minute walk distance in meters
timeFrame: 90 days and 12 months
measure: Quality of life (QoL) scores
timeFrame: 90 days, 180 days and at 12 months
Other outcomes:
Locations:
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum Nordrhein- Westfalen
city: Berlin
country: Germany
facility: Deutsches Herzzentrum Berlin
city: Budapest
country: Hungary
facility: Heart Center of the Semmelweis University
city: Bologna
country: Italy
facility: S. Orsola Hospital, Bologna University
city: Naples
country: Italy
facility: Ospedale dei Colli
city: Astana
country: Kazakhstan
facility: National Research Cardiac Surgery Center
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: İzmir
country: Turkey
facility: Ege University School of Medicine
city: Windsor
country: United Kingdom
facility: Euromacs, Eacts
Study officials:
affiliation: Euro Heart Foundation
name: Osama SOLIMAN, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus MC Rotterdam
name: Kadir Caliskan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.