The Role of Trimetazidine on Right Ventricle Function in Pulmonary Arterial Hypertension Patients in National Cardiovascular Center Harapan Kita Hospital Indonesia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Changes in Right Ventricular Ejection Fraction (RVEF %) After 3 Months Intervention
研究概览
简要总结
The study will evaluate the effect of trimetazidine versus placebo in addition to standard pulmonary arterial hypertension regime on right ventricular function in pulmonary arterial hypertension patients.
详细描述
Right ventricular dysfunction is the worst mortality predictor in pulmonary arterial hypertension (PAH). Recent study has described that approximately 25% of PAH patients will developed into right ventricular failure despite therapeutic reduction of pulmonary vascular resistance. Subsequently, several studies have shown that fatty acid accumulation in right ventricle was inversely correlated with right ventricular function in PAH patients. Several PAH animal studies have revealed that metabolic glucose oxidation impairment through increased aerobic glycolysis, mitochondrial dysfunction, and lipotoxicity play significant role in right ventricular failure. Moreover, several pulmonary hypertension animal studies have demonstrated the benefit of partial fatty acid inhibitor such as trimetazidine on right ventricle function. It was hypothesize that trimetazidine improved right ventricular function through indirect effect of increased glucose oxidation by blocking the Randle cycle. Therefore, we hypothesize that trimetazidine can improve right ventricular function in pulmonary arterial hypertension patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pre-capillary Pulmonary Hypertension patients assessed by right heart catheterization
- •Signed informed consent
排除标准
- •Patient belonging to post-capillary, Isolated post-capillary, or combined post -capillary and pre-capillary pulmonary hypertension according to 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension.
- •Moderate to severe chronic pulmonary obstructive disease
- •Right Ventricular Ejection Fraction > 45% assessed by cardiac magnetic resonance.
- •Documented left ventricular dysfunction with left ventricular ejection fraction < 50% assessed by cardiac magnetic resonance.
- •Severe renal impairment (Serum creatinine > 2.5 mg/dL, eGFR < 30ml/min/1.73 m^2, or routine dialysis treatment).
- •Malignant arrhythmia such as total atrioventricular block or ventricular fibrillation or unstable ventricular tachycardia.
- •Patients who are receiving or have been receiving any investigational drugs within 1 month before the baseline visit
- •Acute or chronic impairment (other than dyspnea) limiting the ability to comply with study requirements
- •Psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with study requirements
- •Females who are lactating or pregnant or those who plan to become pregnant during the study
- •Known Parkinson disease
- •Known hypersensitivity to any of the drug formulation
研究组 & 干预措施
Sugar pill
The participant will received placebo oral capsule bid for 3 months on top of their regular PAH specific therapy.
干预措施: Placebo oral capsule (Drug)
trimetazidine
The participant will received trimetazidine 35 mg bid for 3 months on top of their regular PAH specific therapy.
干预措施: Trimetazidine (Drug)
结局指标
主要结局
Changes in Right Ventricular Ejection Fraction (RVEF %) After 3 Months Intervention
时间窗: Baseline and 3 months after intervention
Right ventricular ejection fraction (RVEF %) assessed by Cardiac MRI at 3 months intervention minus with RVEF at baseline.
次要结局
- Changes in Cardiac Fibrosis After 3 Months Intervention(Baseline and 3 months after intervention)
- Changes in Functional Capacity After 3 Month Intervention(Baseline and 3 months after intervention)
研究者
Hary Sakti Muliawan, MD, PhD
MD,PhD
Indonesia University