Acute and Advanced Heart Failure Blog

Professor Gerhard Pölzl is Chief of the Heart Failure and Heart Transplant Program at the Medical University Innsbruck. His research is focused on clinical studies in advanced and chronic heart failure and on translational studies in cardiomyopathies.

He has been Principal Investigator of the LevoRep clinical trial that tested the efficacy and safety of pulsed infusions of levosimendan in outpatients with advanced heart failure. He is now P.I. of the clinical trial LEODOR, on repetitive use of levosimendan in advanced heart failure.

This blog is focused on the therapeutic options for Acute and Advanced Heart Failure: new data, new studies, new opinions, new trends.

Latest posts

14 March 2018

March 2018 post

I am pleased to announce that there have been notable advances in the LEODOR trial (Repetitive Levosimendan infusions for patients with advanced chronic heart failure), a randomized, double-blind, placebo-controlled multicenter study sponsored by the University of Innsbruck and supported by a grant of Orion Pharma.


The recent achievements include:

- Recruitment of the first patient of a planned 276 cases hospitalized for decompensated heart failure requiring i.v. diuretics, or i.v. vasodilators, or i.v. inotropic therapy, or some combination of these interventions.
- Submission of a formal synopsis of the study protocol to Eur. J. Heart Failure for peer review and publication.


On the administration and communication side, LEODOR is now represented on the internet by its own website ( which proves a wealth of information for everyone with an interest in the conduct and progress of the study and regular updates on recruitment. The “For Patients” page addresses key questions such as:

- What is the purpose of this study?
- Which patients will be chosen to take part?
- What does taking part in this study involve?

While the “For Investigators” page summarizes the aims, design and eligibility criteria for LEODOR and provides additional technical and professional information on subjects including Trial Synopsis, Site Evaluation and Patient Consent through a suite of downloadable PDFs (via The site also offers visitors a photo galley of the 14 principal investigators and a range of opportunities to contact the LEODOR team, which in the fullness of time will include tweets posting significant milestones in the progress of the trial. Go Team LEODOR!

12 February 2018

February 2018 post

Levosimendan roars ahead as LION-HEART results published

Important new support for the use of levosimendan in the management of advanced heart failure (AdHF) has emerged from the LION-HEART study, primary results of which have recently been published in the European Journal of Heart Failure (10.1002/ejhf.1145).

The unique pharmacodynamic and pharmacokinetic qualities of levosimendan have already made it a drug of interest for treating AdHF through intermittent i.v. infusions. LION-HEART is one of the multicenter, double-blind, randomized, parallel-group, placebo-controlled trials in this area of medicine.

The 69 patients in LION-HEART were recruited at 12 centers in Spain: they had chronic AdHF (NYHA grade III or IV) and low mean ejection fraction (~26%). They were randomized in a 1:2 ratio to placebo or to levosimendan (0.2 mcg/kg/min, with no loading dose) administered for 6h in each of 6 treatment cycles at 2 week intervals.

Potent effects of levosimendan were observed on the study primary endpoint of serum concentration of N-terminal pro-B-type natriuretic peptide (NT-proBNP) at 6-month follow-up. The proportion of patients exhibiting a reduction in NT-proBNP levels >25% from baseline was higher in the levosimendan group (48% vs. 9%; P=0.002) and the difference in average percentage change from baseline in NT-pro BNP strongly favored levosimendan (-20% vs. +50%; P<0.001).

Among secondary endpoints, patients treated with levosimendan experienced a reduction in the rate of HF-related hospitalization compared with placebo (hazard ratio 0.25; 95% CI 0.11–0.56; P =0.001) and were less to experience a clinically significant decline in HF-related quality of life in follow-up to 25 weeks (P =0.022).

18 January 2018

January 2018 post

News from the development front: Tenax Therapeutics backs Levosimendan for pulmonary hypertension

Levosimendan has received a big vote of confidence at the beginning of 2018 with the announcement of Tenax Therapeutics that it will conduct a Phase II of the calcium-sensitizing drug to manage Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction (PH-HFpEF). As part of its development program Tenax Therapeutics has announced plans for to start its trial in PH-HFpEF in 3Q2018.

Why this move does make a lot of sense?


- Large unmet need: no drugs are approved for the treatment of PH-HFpEF, even though it is estimated to affect more than 1.5 million people only in the USA.

- Positive levosimendan data: preliminary studies are supportive of favorable effects of levosimendan in patients with pulmonary hypertension [Qiu J et al. Life Sci. 2017;184:30-36, Kleber FX et al. J Clin Pharmacol. 2009;49(1):109-15 ].

- Potential for flexible chronic therapy: thepharmacokinetics and long-lasting effects of levosimendan and its metabolite OR-1896 create potential to use chronic intermittent therapy in the treatment of PH-HFpEF.


Clinical experts who advised Tenax Therapeutics identified the novel mechanisms of action of levosimendan, initial experience with the drug in pulmonary hypertension, and its established position in the management of left and right ventricular failure, as providing a strong rationale for assessing it in PH-HFpEF.