Serial Multiparametric Evaluation of Right Ventricular Function After Left Ventricular Assist Device Implantation

NCT03552679 | Unknown

• 1 other identifier: WT/aj/MEC-2018-1162
• Study Type: observational
• Target: 600
• Locations: 7 countries
• Sites: 9

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.

Conditions

Right Heart Failure

Keywords

Right Heart Failure; Ventricular Assist Device; Mortality; ICU Stay; Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Moderate or severe RHF

  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).

  12 months

Secondary Outcomes (20)

• Severe RHF composite

  1 week, 30 days, 90 days, 180 days, 12 months

• All-cause death

  1 week, 30 days, 90 days, 180 days, 12 months

• Cardiovascular death

  1 week, 30 days, 90 days, 180 days, 12 months

• Death or urgent transplantation

  1 week, 30 days, 90 days, 180 days, 12 months

• Length of post-operative Intensive Care Unit (ICU) stay

  30 days, 90 days, 180 days, 12 months

Study Arms (1)

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.

Diagnostic Test: Echocardiography

Interventions

Echocardiography DIAGNOSTIC_TEST

Echocardiography

LVAD recipients

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive patients who underwent LVAD implantation using main stream devices

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Erasmus Medical Center: lead
• The European Association for Cardio-Thoracic Surgery: collaborator

Study Sites (9)

Herz- und Diabeteszentrum Nordrhein- Westfalen

Bad Oeynhausen, Germany

NOT YET RECRUITING

Deutsches Herzzentrum Berlin

Berlin, Germany

NOT YET RECRUITING

Heart Center of the Semmelweis University

Budapest, Hungary

NOT YET RECRUITING

S. Orsola Hospital, Bologna University

Bologna, Italy

RECRUITING

Ospedale dei Colli

Naples, Italy

NOT YET RECRUITING

National Research Cardiac Surgery Center

Astana, Kazakhstan

NOT YET RECRUITING

Erasmus Medical Center

Rotterdam, Netherlands

RECRUITING

Ege University School of Medicine

Izmir, Turkey (Türkiye)

RECRUITING

Euromacs, Eacts

Windsor, United Kingdom

ACTIVE NOT RECRUITING

Related Publications (1)

• 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.

  PMID: 28847897 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Acute Kidney Injury

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Osama SOLIMAN, MD, PhD

  Euro Heart Foundation

  PRINCIPAL INVESTIGATOR

• Kadir Caliskan, MD, PhD

  Erasmus MC Rotterdam

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Osama SOLIMAN, MD, PhD

CONTACT

+31643158470; osoliman@eurohf.org

Kadir Caliskan, MD, PhD

CONTACT

+31681268158; k.caliskan@erasmusmc.nl

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Cardiology

Study Record Dates

• First Submitted: May 27, 2018
• First Posted: June 12, 2018
• Study Start: June 24, 2018
• Primary Completion: February 1, 2021
• Study Completion: July 1, 2021
• Last Updated: October 11, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1); TU (1); GB (1); KA (1); DE (2); NL (1); IT (2)