The University Medical Center Groningen (UMCG) is an academic hospital located in Groningen, the Netherlands. It is affiliated with the University of Groningen and serves as one of the main medical centers in the northern region of the Netherlands. UMCG offers a wide range of medical services, including specialized care, research, and education. It is also renowned for its leading contributions to medical research and innovation.

Role in the Project

The University Medical Center Groningen (UMCG), as Leader of WP2, will:

1. Re-analyze BIOSTAT-CHFcohort and re-test biobanked samplesto derive a biomarker-based score predicting patients outcome and congestion relapse based on diuretic management.
2. Validate the score in BIOSTAT-CHF validation cohort.

The University of Brescia is a young university with strong roots in one of the richest and most innovative areas in Europe. It contributes to the sustainable development of a territory in search of a balance between industrial development, environmental sustainability and quality of life. The University is a “free learning community” which expresses its social responsibility by committing itself to promoting a peaceful and open society through the inclusion and integration of the many diversities within it.

Role in the Project

The Università degli Studi di Brescia will be actively participating as Partner of Work Package 2 – identification of relevant biomarkers from existing retrospective cohorts, and in WP6 – Validation of the companion diagnostic strategy in a randomized controlled clinical study.
Validation of the companion diagnostic strategy in a randomized controlled clinical study (WP6).

Karolinska University Hospital is one of the largest university hospitals in Europe. The hospital has a triple assignment of healthcare, research and education, and guiding vison – “Patient first”. The hospital works to deliver closely with the Karolinska Intitute, providing training and conducting world-class medical research in many fields. Together, they form an academic healthcare system hub generating new and improved medical outcomes and accelerating the time to patient access of the benefits they bring.

Role in the Project

Karolinska University Hospital will take care of :

• Validation of the companion diagnostic strategy in a randomized controlled clinical study (WP6)
• (Identification of relevant biomarkers from existing independent)

We are a world-renowned university hospital center with a European dimension. Our 38 hospitals welcome more than 10 million sick people each year: in consultation, in emergencies, during scheduled hospitalizations or in home hospitalization, at all ages of life. We provide a public health service for all, 24 hours a day. It is for us both a duty and a source of pride.

Role in the Project

Assistance Publique – Hôpitaux de Paris will be involved in WP6 – Validation of the companion diagnostic strategy in a randomized controlled clinical study. It will allso function as ​clinical partner, involved in key activities as ​the recruitment of patients and follow-up.

The idea of establishing a University in Greece emerged alongside with the Greek War of Independence, also known as the Greek Revolution. The National and Kapodistrian University of Athens, officially founded in April 14th, 1837, is the first University not only of Greece but both the Balkan peninsula and the Eastern Mediterranean region.

Role in the Project

They will be involved in the following activites:

• Validation of the companion diagnostic strategy in a randomized controlled clinical study (WP6).​
• Coordination and project management (WP1). ​
• Companion diagnostic tool kit exploitation plan (WP7).

The Ljubljana University Clinical Center includes a large group of clinics, departments and other services dedicated to the health care of our citizens as well as foreign citizens. Due to the large number of different clinics, the working methods differ between the individual units. The vision of the University Clinical Center of Ljubljana is to remain a modern medical institution, which will be equivalent to similar institutions in the developed world in terms of its offer and expertise in the field of medicine.

Role in the Project

The Ljubljana University Clinical Center will be involved in the conduction of the clinical trial.

The Germans Trias i Pujol Research Institute (IGTP) is a public research centre located in Badalona. Its main objective is to increase scientific knowledge in order to transform it into solutions to improve the health and medical care of patients and the community.

The Institute is associated with one of the major university hospitals in the Barcelona area, the Germans Trias i Pujol Hospital, and is part of the Can Ruti biomedical campus. IGTP is a CERCA centre and is also accredited as a centre of excellence by the Instituto de Salud Carlos III (ISCIII) and is in charge of coordinating the management and scientific strategy of the campus, working in close collaboration with the other centres.

Role in the Project

The Germans Trias i Pujol Research Institute will be actively involved in WP6 – Validation of the companion diagnostic strategy in
a randomized controlled clinical study – and WP7 – Companion diagnostic tool kit exploitation plan.

INCLIVA manages biomedical research carried out by the Hospital Clínico Universitario in Valencia and its Health Department, as well as certain scientific excellence groups from the Faculty of Medicine at the University of Valencia and the Carlos Simon Foundation.

NCLIVA currently has more than 700 researchers of recognised prestige in the international scientific community and has top-notch technology for the development of quality research certified by different certifications.

In the past few years, the Institute’s activity has grown substantially, as shown by its development of several important international projects and in its participation in the main European Research Networks. Also stands out its contribution to international clinical trials, especially the work of the Phase I Oncological Clinical Trials Unit, with the Hospital Clínico Universitario in Valencia being one of the few centers in Spain which performs this kind of studies.

Role in the Project

INCLIVA will be:

• Involved in WP6. Validation of the companion diagnostic strategy in a randomized controlled clinical study.​
• Involved in WP7. Companion diagnostic tool kit exploitation plan.​
• Involved in WP8. Communication and dissemination. 

KU Leuven is an international community where innovative research forms the basis of all courses. Driven researchers and curious students continuously gain new insights and use their knowledge to tackle the challenges of our time. Education at KU Leuven is based on scientific research, ranging from fundamental to highly applied. It challenges you, stimulates your curiosity and opens up your future. The university offers bachelor’s and master’s programs at 10 locations in Flanders.

Role in the Project

KU Leuven will be working mainly on WP6 – Validation of the companion diagnostic strategy in a randomized controlled clinical study.​

It will also be involved in WP1,7,8.

Region Hovedstaden, also known as the Capital Region of Denmark, is one of the five administrative regions in Denmark. It encompasses the Greater Copenhagen area and the surrounding municipalities in the eastern part of the country, including the city of Copenhagen, the capital of Denmark. The region is responsible for various administrative tasks, including healthcare, regional development, and social services.

Role in the Project

Their role in the project will focus on:

• Samples​
• Clinical data​

The University of Bologna (Italian: Alma Mater Studiorum – Università di Bologna, abbreviated Unibo) is a public research university in Bologna, Italy. Founded in 1088 by an organised guild of students (studiorum), it is the oldest university in continuous operation in the world, and the first degree-awarding institution of higher learning. At its foundation, the word universitas was first coined. The University of Bologna has campuses in Cesena, Forlì, Ravenna and Rimini as well as branch centres abroad in Buenos Aires, Argentina, New York, Brussels, and Shangai. It houses the fully funded boarding college Collegio Superiore di Bologna, the Bologna School of Advanced Studies, the botanical gardens of Bologna, a large number of museums, libraries and archeological collections as well as the Bologna University Press.

Role in the Project

The role of Unibo in BIOTOOL-CHF will focus on several aspects:

• Data management, ethical, and GDPR compliance
• Preparation of the eCRF
• Cleaning of the database and assessment of the prognostic accuracy of biomarkers and devices.
• Economic Evaluation of the companion diagnostic BIOTOOL-CHF in congestive heart management.
• Outreach and training activities (Leader: WH, co-leader: UNIBO).
• Definition of recommendations to be implemented in clinical guidelines for healthcare providers.

The Onassis Cardiac Surgery Center is a renowned medical institution specializing in cardiac care and surgery located in Athens, Greece. Established in 1975, it has earned a reputation for excellence in treating cardiovascular diseases and conducting cutting-edge cardiac surgeries. The center boasts state-of-the-art facilities, highly skilled medical professionals, and a multidisciplinary approach to patient care. It is committed to providing comprehensive cardiovascular services, including diagnosis, treatment, rehabilitation, and research, to patients from Greece and around the world. With a focus on innovation, patient-centered care, and medical advancement, the Onassis Cardiac Surgery Center remains a leading institution in the field of cardiac medicine. It is the only heart transplantation centre in Greece. 

Role in the Project

The key activities on which the Onassis Cardiac Surgery Centre will focus on are:

• Validation of the companion diagnostic strategy​ in a randomized controlled clinical study (WP6)​
• Companion diagnostic toolkit exploitation plan (WP7) – Economic evaluation of the companion diagnostic BIOTOOL-CHF in congestive heart management; IPR management​

Inserm brings together 15,000 researchers, engineers, technicians and administrative staff, with a common objective: improving the health of all through progress in knowledge of living things and diseases, innovation in treatments and public health researchThis mission is based on the work of  9 thematic institutes , whose role is to take stock of research in their field and to lead this research. Furthermore, research on infectious diseases – emerging like Covid-19, but also on AIDS, viral hepatitis or tuberculosis – is coordinated and funded by the ANRS Emerging infectious diseases an independent agency of Inserm.

Role in the Project

The main activities in which INSERM will be focusing on are:

• Harmonization of database including newly tested biomarkers
• Analysis and characterization of clinco-biological profiles of congestion
• Selection of candidate biomarkers for the development of AI-based models
• Analysis and development of congestion-profile-based risk model of hospitalization for HF
• Performance evaluation of the AI-based models in BIOTOOL-CHF derivation and validation cohort
• Storage, management, and analysis of the clinical data
• Validation of biomarkers and AI models for the clinical study

Predict4Health is a tech company on a mission to improve the care of patients with end-stage chronic diseases by bridging the gap between clinical care and clinical research. We develop a software platform powered by AI to support physicians in their clinical decisions and use multidimensional datasets to support the development of new therapeutics within the Pharma industry. We leverage the iBox©, an algorithm clinically validated and qualified by the European Medicines Agency as the only qualified digital biomarker for assessing surrogate endpoints of graft survival for transplanted patients. Our medical device platform is used in clinical practice for effective management of grafts and prediction of therapy response and in clinical trials to shorten study duration and significantly reduce costs, fostering therapeutic innovation. The solution is already reimbursed in France and is deployed in thousands of patients in Europe and in the US.

Role in the Project

Predict4Health is responsible for the development of the decision-support tool and will actively participate in its clinical validation, market access, and regulatory strategy formulation.

ECRIN, the European Clinical Research Infrastructure Network,  facilitates multinational clinical research, through the provision of advice and services for the set-up and management of investigator or SME led clinical studies in Europe. ECRIN unites national networks of clinical trial units across Europe, through its scientific partners, to fulfil its vision of generating scientific evidence to optimise medical practice.

Role in the Project

The role od ECRIN within the BIOTOOL-CHF project will focus on:

• Prospective clinical study management and coordination with the lead CTU (HCF Onlus)
• Management of Local Regulatory Authority (Ethical Committee (EC) and competent Regulatory Authorities (RA)) approval in collaboration with the Sponsor
• Monitoring of the clinical trial: handling all tasks related to monitoring including training, on-site visits, reporting, and remote monitoring across country sites

At the Istituto Superiore di Sanità (ISS), the main centre for research, control and technical-scientific advice on public health in Italy, 1800 people, including researchers, technicians and administrative staff, work daily with the aim of protecting the citizens’ health.

The main activities of the ISS are distributed in 6 Departments, 16 National Centres, 2 Reference Centres, 5 technical-scientific services and a Notified Body for the assessment of the suitability of medical devices.

Role in the Project

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Warrant Hub, part of Tinexta Business Innovation, is the leading strategic and financial consulting company for innovation, digital transformation, and sustainable business development. With a structure of over 900 professionals, Warrant Hub has been operating for almost 30 years throughout Italy.  It has gained experience in different sectors of the industrial fabric, building a portfolio of over 10,000 clients. The network of partnerships in academia, technology, finance, and institutions allows Warrant Hub to present itself as a partner capable of supporting companies in the increasingly complex challenges they face. To support research, development and innovation projects, production investments and digitalisation, the Warrant Hub team provides companies with its transversal, technical and technological skills, and its many years of experience in the field of concessional finance. Founded in Correggio where it maintains its headquarters, it operates throughout Italy as well as in Belgium, Bulgaria, France, and Spain.

Since 2008, the European Funding Development (EFD) Business Unit of Warrant Hub S.p.A supports enterprises and private and public bodies, at national and international level, in participating to and managing Research and Innovation projects funded by the European Commission. EFD offers methodological and strategic consultancy for approach and participation in European research and innovation funding programmes, like Horizon Europe and LIFE Programme, in a complete cycle from the analysis of the sectorial policies to the conclusion of the research and innovation projects. EFD supports its customers and partners in networking, project ideas definition, project planning/submission, negotiation, management, dissemination, and exploitation of project results. EFD also participate directly to the European projects with the roles of coordinator and partner for project management, communication, dissemination, and exploitation.

Role in the Project

Communication and dissemination management

The University Hospital Schleswig-Holstein (UKSH) with its locations in Kiel and Lübeck is one of the largest medical care centers in Europe. It serves to warrant maximum medical care in the northernmost federal state and guarantees medical-technical care at the highest level, especially for patients who require highly differentiated diagnosis and therapy. The unique feature of university medicine is the interaction of health care, research and teaching with the result that scientific findings flow directly into the health system. The UKSH maintains the entire spectrum of medicine and multidisciplinary centers, cares for patients with rare diseases and extreme medical costs, operates university outpatient clinics and provides emergency care. The UKSH is the only maximum provider in Schleswig-Holstein. With 16,000 employees in over 85 clinics and institutes, UKSH is the largest employer and training provider in Schleswig-Holstein. Strategic personnel development, corporate health management and the certified compatibility of work and family life are integral parts of the corporate culture.

Role in the Project

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AISC APS – Italian Association of Heart Failure Patients and Cardiovascular Prevention, is a Social Promotion Association, established in Rome on 14 April 2014 and representing Heart Failure Patients and promoting Cardiovascular Prevention. Actually a national level we have over 6000 patients as affiliates. AISC is a nonprofit association of social utility; our “mission” consists in supporting and disseminating knowledge of the heart failure ,which are the leading cause of hospitalization and mortality in the Western world for patients over 65 years of age ,and contributing on the prevention of cardiovascular diseases.

Role in the Project

• Promote information on heart failure and cardiovascular diseases to increase the awareness among patients and caregivers;
• Carry out an educational function aimed at developing the ability to recognize the diseases symptoms and follow the treatments to improve the quality of life of patients and reduce the need for hospitalizations;
• Organize and promote meetings and initiatives in order to educate on a correct lifestyle to avoid the evolution of the disease;
• Represent the voice of patients suffering from heart failure and cardiovascular diseases at an institutional level but also cooperating with similar international associations.;
• Promote patient empowerment activities towards digital healthcare

IMA – Industria Macchine Automatiche S.p.A. is a multinational Italian company based in the Metropolitan City of Bologna, Italy. Established in 1961, IMA Group is a leader in the design and manufacture of automatic machines for the processing and packaging of pharmaceuticals, cosmetics, food, tobacco, tea and coffee. IMA’s mission is to invest in technologies that will improve the quality of life on the planet, reduce food waste, increase access to more effective drugs and allow greater respect for the environment.

Role in the Project

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The Erasmus University Rotterdam is one for thinkers and doers, for people who want to realize their ambitions. But how do we make our values ​​tangible in all our means of communication? On these pages, design agencies, printers and employees will find inspiration and information about our corporate identity.

Role in the Project

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The Foundation is a research body whose aim is the fight against cardiovascular diseases and the opening of new personalized therapeutic horizons. The “per il Tuo cuore” HCF Onlus Foundation was founded in 1998 with the name of “Italian Foundation for the fight against Cardiovascular Diseases – Heart Care Foundation Onlus”, legally recognized by the Ministry of Health since September 2000 and included in the register of non-profit organisations.

The Foundation’s mission is the development of innovative strategies capable of accelerating progress in the field of:

• RESEARCH
• HEALTH EDUCATION
• TRAINING

Role in the Project

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FHNW is one of Switzerland’s leading universities of applied sciences and arts, actively involved in teaching, research, continuing education and service provision – both innovative and practice-oriented. Its broad range of degree programmes, hands-on concept, innovative, application-oriented research and global network make FHNW a diversified and appealing educational institution, a sought-after partner to industry and an attractive employer in northwestern Switzerland.

Role in the Project

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