Impact of trimetazidine on endothelial function and biomarkers correlating with the prognosis of heart failure with preserved ejection fraction
Key facts
- Where
- Bydgoszcz, Elbląg, Gdansk, Gdynia, Lodz, Olsztyn, Słupsk, Warsaw, Warszawa és Włocławek, LengyelországSee the 12 sites
- Phase
- 4. fázis
Where in Lengyelország
- Szpital Uniwersytecki Nr 1 Im. Dr. A. Jurasza W BydgoszczyBydgoszcz, LengyelországNo longer taking part
- KARDIOLAB Poradnia KardiologicznaElbląg, LengyelországNo longer taking part
- Copernicus Podmiot Leczniczy Sp. z o.oGdansk, LengyelországNo longer taking part
- Uniwersyteckie Centrum KliniczneGdansk, LengyelországNo longer taking part
- NZOZ Centrum Medyczne Dąbrowa-DąbrówkaGdynia, LengyelországNo longer taking part
- Uniwersyteckie Centrum Medycyny Morskiej i TropikalnejGdynia, LengyelországNo longer taking part
- Salve Medica Sp. z o.o. S.K.Lodz, LengyelországNo longer taking part
- Specjalistyczna Praktyka Lekarska — "NEFRON" Beata Januszko-GiergielewiczOlsztyn, LengyelországNo longer taking part
- Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka w Słupsku Sp. z o.o.Słupsk, LengyelországNo longer taking part
- Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory ReicherWarsaw, LengyelországNo longer taking part
- Państwowy Instytut Medyczny Ministerstwa Spraw Wewnętrznych i AdministracjiWarszawa, LengyelországNo longer taking part
- Praktyka Lekarska - Tomasz BorkowskiWłocławek, LengyelországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Medical University Of Gdansk
- Trial code
- EU 2023-506138-65-00
- Record updated
- 2025. május 25.
- Original description
Assessment of the number of events resulting from heart failure exacerbation or cardiovascular death.Read full original descriptionShow less
Assessment of the number of events resulting from heart failure exacerbation or cardiovascular death.
Inclusion: Expressing willingness to participate in the study and after obtaining information about the study, signing the informed consent form for participation in the clinical study. 2. Age at study entry ≥55 years and ≤85 years; 3. NYHA Class I to III at last screening assessment. 4. Documented diagnosis of HFpEF or new diagnosis of HFpEF based on HFA-PEFF score ≥ 5 by a cardiologist during the screening phase. 5. LVEF ≥ 50% on echocardiographic screening. 6. No modification of pharmacotherapy for at least 3 months prior to screening.
Exclusion: Current treatment in another clinical trial. 2. Hypersensitivity to trimetazidine. 3. Symptoms of parkinsonism. 4. Unavailability for all visits. 5. ≥3 class in CCS scale 6. Revascularization or venous thromboembolism within 3 months prior to the screening visit. 7. Hemodynamically significant valvular disease, hypertrophic cardiomyopathy, myocarditis and pericarditis, congenital heart disease, cardiac amyloidosis. 8. Severe ventricular arrhythmias. 9. Uncontrolled BP: SBP >170 or <85 mmHg or DBP >100 mmHg at screening or randomization visit; 10. Resting heart rate (HR) >110/min or <50/min; 11. Chronic kidney disease with eGFR <30 mL/min. 12. Blood total bilirubin ≥2 times the upper limit of normal (ULN) or ALAT or AST ≥3 times the (ULN). 13. Patient life expectancy <2 years. 14. Diagnosed malignant neoplasm within 5 years prior to screening or active cancer disease. 15. Organ transplant recipient. 16. Alcoholism. 17. Active infection as assessed by the investigator 18. Severe dysfunction of the musculoskeletal system. 19. Blood concentration of TSH or fT4 exceeding by 50% the upper and/or lower limit of the reference range. 20. Taking any drugs related to the treatment of Parkinson's disease, i.e. levodopa, dopamine agonists, anticholinergics, MAO-B inhibitors, COMT inhibitors, amantadine within three months before screening. 21. A woman trying to get pregnant naturally or in vitro, or a woman who is menstruating unwilling to protect herself against unplanned pregnancy.