Impact of trimetazidine on endothelial function and biomarkers correlating with the prognosis of heart failure with preserved ejection fractio

Phase 1

• Conditions: MedDRA version: 20.0Level: LLTClassification code: 10008908Term: Chronic heart failure Class: 10007541; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]; Heart failure with preserved ejection fraction; MedDRA version: 20.1Level: LLTClassification code: 10076396Term: Heart failure with preserved ejection fraction Class: 10007541

• Registration Number: CTIS2023-506138-65-00
• Lead Sponsor: Medical University Of Gdansk

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-04
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 468

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Assessment of time to hospitalization or death from any cause;Secondary Objective: Assessment of time to hospitalization for cardiovascular reasons; Assessment of time to hospitalization for any reason; Assessment of time to death from any cause; Assessment of time to death from cardiovascular causes; Assessment of the quality of life using the EQ-5D test; Assessment of symptoms of heart failure and angina; Assessment of endothelial function, inflammation and heart failure based on biomarkers; Assessment of endothelial function (FMD) and microcirculation (LSCI); Evaluation of the systolic and diastolic function of the heart based on echocardiography;Primary end point(s): Time to hospitalization for worsening heart failure or death from a cardiovascular cause

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Time to hospitalization for cardiovascular reasons; Time to hospitalization for any reason; Time to cardiovascular death; Time to death from any cause; EQ-5D score; KCCQ-12 score, NYHA Class, CCS Class; Level of biomarkers related to endothelial function; Inflammation biomarkers levels; Level of biomarkers associated with heart failure; Endothelial function parameters (FMD); Microcirculation Function Parameters (LSCI); Left ventricular systolic function parameters (ejection fraction