The Role of Trimetazidine on Right Ventricle Function in Pulmonary Arterial Hypertension

• Status: Completed
• Trial end date: 2018-12-14
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indonesia University
• Treatments: Trimetazidine

Criteria

Inclusion Criteria:

• Pre-capillary Pulmonary Hypertension patients assessed by right heart catheterization

• Signed informed consent

Exclusion Criteria:

• 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