Current Clinical Research Groups

Following a comprehensive call for proposals and 44 applications submitted, the first three groups ‘Austrian Digital Heart Programme’, ‘MOTION’ and ‘ATTRACT’ were selected in 2023 by an internationally renowned expert committee chaired by Prof. Lieselotte Højgaard, Professor of Medicine and Technology at the University of Copenhagen, Denmark, and Head of the Department of Clinical Physiology, Nuclear Medicine and PET at the Danish Rigshospitalet.

The Clinical Research Groups CRG funding programme launched by the LBG is Austria’s first collaborative research initiative with a clear focus on patient-oriented, medically relevant topics in the field of non-commercial clinical research.

Lead Institution: Medical University of Vienna

Partner institutions: CBmed GmbH, Medizinische Universität Graz, Kepler Universitätsklinikum/Johannes Kepler Universität, Karl Landsteiner Universität für Gesundheitswissenschaften, Medizinische Universität Innsbruck, Danube Private University, Austrian Institute of Technology (AIT)

Head: Assoc.-Prof. PD Dr. Anna Sophie Berghoff

Mentor: Univ.-Prof. Dr. Matthias Preusser

Deputy Head: DDr. Maximilian Mair

Glioblastomas are the most common malignant brain tumours in adults and are characterised by a poor prognosis and high symptom burden. Despite intensive research, no therapeutic breakthroughs have been achieved. This is partly due to the fact that most active substances only reach the brain to a limited extent and current therapies often have little effect. In around 60-70% of glioblastomas, the promoter of the O6 methylguanine methyltransferase (MGMT) gene is unmethylated, which leads to a particularly poor response to chemotherapy and limited survival. The development of individualised therapeutic approaches based on tumour biology is therefore urgently needed. ATTRACT aims to establish the concept of functional precision medicine and thus enable patients to receive customised therapy. The project is made possible by an interdisciplinary, Austria-wide consortium that builds on the long-standing expertise of neuro-oncological centres and basic and translational research institutions.

The first step is the establishment of an Austria-wide biobank for glioblastomas (GlioBank). Five clinical centres (Vienna, Graz, St. Pölten, Linz, Innsbruck) are involved, which include patients and collect sample material. A total of around 600 patients (age ≥18 years, radiological suspicion of glioblastoma) will be included in this biobank over a period of 4 years, from whom tumour tissue, blood and stool will be collected at the time of diagnosis. Fresh tumour samples are then used to cultivate tumour cells ‘ex vivo’. These so-called ‘patient-derived tumour cells’ (PDCs) are used for a drug testing platform in which the anti-tumour effect of various active substances is to be tested. If sufficient tissue is available, additional tumour samples are stored locally at the respective clinical centre for further research. The benefits of this approach will be investigated in a clinical trial involving 240 adults with newly diagnosed glioblastoma (IDH wildtype, MGMT promoter-unmethylated). They will be randomly assigned to a comparison group (routine diagnostic work-up of the tissue) or the experimental group (additional PDC-based drug testing). For more information, refer to https://clinicaltrials.gov/study/NCT06512311?term=ATTRACT&rank=4

Based on these analyses, a personalised therapy recommendation is determined by a panel of experts (known as a ‘molecular tumour board’), in which the treating medical staff are also involved. This therapy recommendation is then discussed individually with the patient, whereby an experimental therapy can be offered as part of an individualised treatment trial. The established biobank will then be used to investigate therapy response and resistance using molecular biological methods on PDCs and tumour tissue samples. The results will be correlated with clinical information using the collected material and radiological data. An integrative data analysis, which is also based on artificial intelligence methods, should enable the identification of new biomarkers.

Lead Institution: Medical University of Innsbruck

Partner institutions: Austrian Institute of Technology (AIT), Medical University Graz, UMIT Tirol

Head: Priv.-Doz. Dr. Sebastian Reinstadler, PhD

Mentor: Univ.-Prof. Dr. Axel Bauer

Deputy Head: Dr. Michael Schreinlechner

Contact: vasb@chyfxbagebyyr.ng

Atrial fibrillation (AF) is the most common heart arrhythmia, affecting around 1-2% of the population, with prevalence increasing with age. Undiagnosed and untreated atrial fibrillation can have serious consequences, such as heart failure and strokes.

Digital devices like smartphones and smartwatches already allow for monitoring of pulse and heart rhythm. When these technologies are used systematically, they can serve as a screening tool for the early detection of atrial fibrillation. Combined with appropriate medical support, screening has the potential to significantly reduce morbidity and mortality associated with AF.

The Austrian Digital Heart Program aims to implement this approach for the early detection of AF nationwide. The goal is to develop a smartphone-based screening strategy for AF and a digital medical guidance, under the scientific leadership of the Medical University of Innsbruck, in close collaboration with the Medical University of Graz, UMIT Tirol, and the Austrian Institute of Technology.

Individuals aged 65 and older are invited to use the specifically developed study app “Pulskontrolle” and perform regular short pulse measurements. Through health tips and personalized feedback on the measurements, participants receive support to promote their heart health and better understand their individual risks. In the case of abnormal readings or upon request, telemedicine consultation and further medical clarification are available. The remote and easily accessible measurements allow a wide range of people to participate in the program. The insights gained could pave the way for future preventive initiatives and accelerate the digital transformation of healthcare.

Since the launch of the Clinical Research Group in 2023, the digital health innovation platform has been developed, including the “Pulskontrolle” app. A pilot study is currently underway at the Medical Universities of Innsbruck and Graz, where the newly developed digital solutions are being tested with the target group to collect valuable feedback. This patient-centered pilot study emphasizes ease of use and accessibility, aiming to maximize user acceptance and adherence for the upcoming nationwide randomized clinical trial.

In addition to the development of the digital environment, preparations have been made for the launch of the largest digital study ever conducted in Austria, including the design of the study, participant recruitment strategies, data collection methods, and analysis plans. Another key activity will be the establishment of a robust IT infrastructure required to support the clinical study. This includes ensuring the highest level of data security, developing systems for data collection and management, and creating interfaces that facilitate smooth operation and monitoring of the study.

Lead Institution: Medical University Vienna

Head: Univ.-Prof. Priv.-Doz. Dr.med.univ. Thomas Reiberger

Mentor: Univ.-Prof. Dr.med.univ. Michael Trauner

Deputy Head: Ap.Prof. Priv.-Doz. Dr.med.univ. et scient.med. Mattias Mandorfer

Contact: Olivia Gugler byvivn.thtyre@zrqhavjvra.np.ng, Alexandra Weisgram nyrknaqen.jrvftenz@zrqhavjvra.np.ng

The CRG MOTION focuses on improving the diagnosis, treatment and prognosis of patients with liver disease, specifically via investigating the underlying pathomechanisms of portal hypertension (PH), the leading cause of severe or even fatal complications in patients with liver disease. The assembled clinical research group (CRG) began finalising protocols for three clinical trials in October 2023, which will include patients with asymptomatic but advanced liver disease (compensated, cACLD: TECA trial) and patients with symptomatic advanced liver disease (decompensated, dACLD: NOPE trial) and patients with vascular liver disease (PSVD: EXPOSURE trial).

The funding of our CRG enabled us to set up an optimized workflow and processes for our research projects and acquisition of valuable patient data and biosamples for molecular analyses. We were able to confirm the central role of the renin-angiotensin (RAS) signalling pathway (that will be therapeutically targeted in the TECA study) in cACLD patients and of systemic inflammation (that will be targeted in the NOPE study) in dACLD patients. Several new patients were newly enrolled in the associated biobank studies, specifically the Vienna Cirrhosis Study (VICIS) and the Vienna Liver and Vascular Liver Disease Study (VALID). Members of the CRG MOTION were trained in the gold standard methodology for evaluating PH, the measurement of the hepatic venous pressure gradient (HVPG), which is also used as the primary endpoint for the TECA and NOPE studies.

By analysing our VICIS patient dataset, new algorithms for the non-invasive diagnosis of advanced liver disease and PH were developed. This allowed us to demonstrate that the additional measurement of spleen stiffness (SSM) could improve existing non-invasive algorithms. These study results were presented at the world’s largest liver conference (EASL Congress 2024 in Milan, Italy) and published prominently in the top journal Lancet Gastroenterology and Hepatology. The workflow to assess coagulation profiles in patients with PH has been established by recruiting dedicated MOTION team members and the first data sets are currently being analysed. A large number of imaging data (CT scans) from patients with cACLD and dACLD were processed with specifically developed software programs and analyzed by artificial intelligence approaches (machine learning models), enabling an assessment of PH severity based on routine imaging examinations. Finally, the expertise of a newly recruited basic scientist enabled the detailed characterization of patient blood samples for specific types of circulating blood vessel cells at the single cell level. The initial results of this basic research were presented at an international conference in September 2024. As soon as the clinical trial protocols have been approved by the European Medicines Agency (EMA), the first patients can be enrolled in the clinical trials.