Gianluigi Savarese

Gianluigi Savarese

Senior Lecturer/Senior Physician | Docent
Telephone: +46852487075
Visiting address: Institutionen för klinisk forskning och utbildning, Södersjukhuset, 11883 Stockholm
Postal address: S1 Klinisk forskning och utbildning, Södersjukhuset, S1 KI SÖS Forskning Kardiologi Savarese, 171 77 Stockholm
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Grants

  • Swedish Research Council
    1 January 2025 - 31 December 2027
    Purpose and aims. Heart failure (HF) is common and linked with poor outcome. Guideline-directed medical therapy (GDMT) improves outcome but is poorly implemented. Barriers to implementation include limited generalizability of randomized trials, comorbidities, socioeconomic disparities, and sub-optimal HF care pathways. We aim to evaluate 1)current use of HF therapies, 2)barriers to implementation, 3)associations of HF therapies with prognosis by trial emulation, 4)a risk score for hyperkalemia, 5)socioeconomic factors as determinants of access to HF care, 6) a registry-based screening strategy to streamline implementation.Time plan/scientific methods. Use of and barriers to the implementation of HF therapies will be investigated in the Swedish HF Registry, where also the trials evaluating the association of HF treatments with outcomes will be emulated. SCREAM will be used to develop a risk score for hyperkalemia. In a proof-of-concept study, SwedeHF will be screened for suboptimally treated HFrEF patients, who will be invited to an “optimization clinic”. The funding will finance the planning/design, data management, execution, and statistical analysis of the sub-projects. Ethical approval was obtained.Relevance. Better implementation of HF GDMT can reduce the impact of HF on the society by reducing morbidity/mortality and optimizing healthcare utilisation. Our projects foster this goal by identifying and addressing barriers to implementation by using registry-based research.
  • BIOmarker based diagnostic TOOLkit to personalize pharmacological approaches in congestive heart failure (BIOTOOL-CHF)
    European Union
    1 June 2023
  • More Effectively Using Registries to suppOrt PAtient-centered Regulatory and HTA decision-making (MORE-Europa)
    European Union
    1 June 2023
  • Registry-based research for implementing use of treatments and trial design in heart failure
    Heart and Lung Foundation
    1 January 2023
  • Deutsche Forschungsgemeinschaft
    1 January 2023
    Heart failure is a global pandemic with a 1-year mortality of approximately 36%. The prevalence in Germany, Italy and Sweden is roughly 2% - and rising in an ageing population. A better understanding of heart failure’s pathophysiology has paved the way for prognosis improving medical drugs like beta blockers, renin-angiotensin system inhibitors, mineralocorticoid receptor antagonists, SGLT2 inhibitors as well as by Vericiguat in selected patients and potentially Omecamtiv mecabil in the future. Randomised controlled trials are today’s gold standard for the assessment of such therapeutical interventions. They are able to describe causal relationships between an intervention and a defined outcome and are therefore the foundation of evidence-based medicine. There are two main quality indicators of trial quality: internal and external validity. Internal validity captures the trial’s capability to rule out other than the intervention’s influence on the outcome. It is impaired by both systematic and random errors. These challenges can be encountered by, e.g., a proper sample size. Increasing the sample size, on the other hand, results in considerable increase of the trial’s expenditure, longer duration of study participant recruitment and exposure of more participants to potential safety issues. Thus, enrichment strategies have been developed by study sponsors and endorsed by regulative authority bodies. However, these strategies may come at the cost of external validity. External validity describes the extent to which a trial’s results can be applied to the target population and can thus be generalised in clinical practice. The aspect of external validity has not been in the scope of clinical research until recently. As a consequence, only current trials have been investigated with a focus on the generalisability of their results to the target population, yet. Therefore, it is of interest to (re-) assess older trials which are still relevant for nowadays guideline recommendations on heart failure medication about their generalisability to a real-world heart failure population. The applicant plans to do so employing the unique Swedish Heart Failure Registry (SwedeHF): SwedeHF is designed as a nationwide continuous health quality and research registry
    it was founded in 2000 and until 2003 implemented in the whole of Sweden. Vastly more than 100,000 registrations and 60,000 patients have been included added by approximately 10,000 further registrations of both known and new patients each year. In this project, the applicant aims to: (1) gain insight into registry-based heart failure research, (2) analyse the generalisability of past HFrEF trials, (3) propose a pragmatic trial design in heart failure research between the poles of internal and external validity and (4) learn fundamentals in registry-based randomised trials and assessing their potential for future evidence-based medicine in heart failure.
  • A European Health Data Toolbox for Enhancing Cardiology Data Interoperability, Reusability and Privacy (DataTool@Heart)
    European Union
    1 January 2022
  • Swedish Heart-Lung Foundation
    1 January 2021 - 31 December 2023
  • Deutsche Forschungsgemeinschaft
    1 January 2021 - 31 December 2022

Employments

  • Senior Lecturer/Senior Physician, Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, 2024-
  • Senior Lecturer/Specialist Physician, Department of Medicine, Karolinska Institutet, 2023-2024

Degrees and Education

  • Docent, Karolinska Institutet, 2020
  • Degree Of Doctor Of Philosophy, Department of Medicine, Solna, Karolinska Institutet, 2018

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