About the study

This study evaluates the effects of trimetazidine on endothelial function and prognosis in patients with heart failure with preserved ejection fraction (HFpEF).

The project aims to determine whether a medicine used in addition to standard therapy can reduce mortality and the number of hospitalisations in this group of patients.

What is HFpEF?

Heart failure with preserved ejection fraction (HFpEF) is a form of heart failure in which symptoms of cardiac dysfunction occur despite preserved pumping function of the heart.

The condition is associated with a high risk of hospitalisation and reduced quality of life, while effective treatment options remain limited.

Why trimetazidine?

Trimetazidine is a metabolic agent used in cardiovascular diseases.

Previous studies have demonstrated beneficial effects in patients with heart failure with reduced ejection fraction (HFrEF), including reduced mortality, fewer hospitalisations and improved quality of life.

These effects do not appear to result from direct action on the classical mechanisms of heart failure, but rather from pleiotropic effects, including anti-inflammatory, antioxidant and metabolic actions, as well as improvement of endothelial function.

Why is a new approach needed?

Despite available therapies, HFpEF remains a condition without a clearly effective pharmacological treatment.

The mechanism of action of trimetazidine suggests that it may positively influence disease progression, particularly through improvement of endothelial function and microcirculation.

Study design

Participants are randomly assigned to receive either trimetazidine (35 mg modified-release tablets taken twice daily) or placebo.

The study treatment is administered in addition to optimal heart failure therapy.

Study assessments

The study evaluates, among others:

• all-cause and cardiovascular mortality;
• number of hospitalisations;
• endothelial function;
• levels of biomarkers associated with prognosis in HFpEF.

Study population

The study plans to enrol 468 patients aged 60–85 years diagnosed with heart failure with preserved ejection fraction (HFpEF).

Participants are randomly assigned in a 2:1 ratio to receive either the investigational treatment or placebo.

Detailed eligibility criteria should be confirmed directly with the study centre.

Study objectives

The primary objective of the study is to evaluate the effects of trimetazidine on mortality and the number of hospitalisations in patients with HFpEF.

The study also evaluates the effects of treatment on endothelial function and biomarkers associated with prognosis.

Organisational information

The project is funded by the Polish state budget through the Medical Research Agency (MRA), project number: 2021/ABM/03/00038.

Project duration: 01 March 2022 – 28 February 2028.

Total project value: PLN 9,999,874.40.