Impact of trimetazidine on endothelial function and biomarkers correlating with the prognosis of heart failure with preserved ejection fraction - NBK531/2/2022

Medical University Of Gdansk0 个研究点目标入组 468 人开始时间: 2023年9月4日最近更新: 2024年7月22日

适应症

试验速览

暂无简介。

•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 7.hsCRP level = 1.5 mg/L.

•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 tumor. 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.

发起方