Impact of trimetazidine on endothelial function and biomarkers correlating with the prognosis of heart failure with preserved ejection fraction
EU CTIS ID: 2023-506138-65-00
What this study is testing
Assessment of the number of events resulting from heart failure exacerbation or cardiovascular death.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. 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
You likely can't join if
- 1. 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.