LeoDOR study - progress update

Our March 2019 blog post from Professor Gerhard Pölzl touching upon the progress of the LeoDOR study

It’s a year since I reported on the status of the LeoDOR study (repetitive levosimendan infusion for patients with advanced chronic heart failure) so I think it’s more than time to bring readers up to date with our progress.

Since I last wrote on this subject, the protocol for the study, authored by myself and 13 distinguished colleagues, has been published [Pölzl G et al. ESC Heart Failure 2019;6(1):174-181 DOI:10.1002/ehf2.12366].

The trial’s dedicated website, https://leodortrial.com/, is up and running and offers information to prospective patients and investigators, including a Trial Information Sheet and Site Evaluation documents, and clear plain language answers to questions such as “what is the purpose of this study” and “what does taking part in this study involve?”. LeoDOR researchers can keep up-to-date and exchange thoughts and information via the sharepoint facility operated via the website.

The first 10% of the planned 264 patients have been enrolled, and the dedicated Twitter feed (@LeodorTrial) has announced the participation of several centres in Germany, including Innsbruck (where the first patient was recruited), Linz, Berlin, Braunau, Kiel, Würzburg, plus Oulu (Finland), Debrecen (Hungary) and Ljubljana (Slovenia).

Underpinning and inspiring all these exertions is the fact that while findings from over 10 double-blind clinical trials or registries (including LevoRep, LION-HEART, LAICA, RELEVANT, etc.) have consistently supported the view that repeated infusion of levosimendan benefits patients with advanced heart failure, no single study has been statistically powered enough to generate conclusive results. Clearly, a larger study is needed and it is our confident hope that LeoDOR (NCT03437226) will be that trial.

LeoDOR is the first major trial of intermittent levosimendan to use a global rank score methodology to assess the impact of therapy. This global rank endpoint is a composite of: (i) time to death or urgent heart transplantation or VAD implantation; (ii) time to a non-fatal HF event requiring i.v. vasoactive therapy; (iii) time-averaged proportional change in NT-proBNP from baseline to 14 weeks. This novel methodology allows each patient to contribute to the overall endpoint, thereby optimising statistical power while keeping the number of patients within manageable limits.

We’re a way off seeing the final results of LeoDOR yet and I expect to deliver more updates via this blog before that day arrives, but the study is now well and truly underway. I extend my best wishes and gratitude to all patients and investigators who have agreed to contribute to this important initiative in advanced heart failure treatment.

 

Publications (20)
  • ESC 2017 in Barcelona

    Professor Gerhard Pölzl discusses the European Society of Cardiology annual meeting 2017, where several sessions were held on the use of levosimendan in heart failure.

  • FIGHT, PERSIST and LEVOREP

    Professor Gerhard Pölzl highlights the significance of the FIGHT, PERSIST and LEVOREP trials which investigate levosimendan as a treatment for heart failure.

  • LEODOR trial - recent advances

    There have been some recent achievements in the LEODOR trial including a new website to facilitate administration and communication and submission of a formal study protocol synopsis to the European Journal of Heart Failure.

  • Levosimendan roars ahead as LION-HEART results published

    Professor Gerhard Pölzl reports primary results from the LION-HEART study in the management of advanced heart failure where among secondary endpoints, patients treated with levosimendan experienced a reduction in the rate of HF-related hospitalisation compared with placebo.

  • What does the Advanced Heart Failure patient want?

    Professor Cynthia M Dougherty and colleagues outline an array of options for the treatment of advanced heart failure (HF) that create – quite reasonably – the impression that we are in a golden age of therapeutic possibilities for this difficult condition.

Anmelden/Registrieren Maximieren Minimieren