NCT03273387

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

The Role of Trimetazidine on Right Ventricle Function in Pulmonary Arterial Hypertension Patients in National Cardiovascular Center Harapan Kita Hospital Indonesia

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Indonesia University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Precapillary Pulmonary Hypertension

Interventions

Type	Name	Description
DRUG	Trimetazidine	The participant will received trimetazidine 35 mg bid for 3 months on top of their regular PAH specific therapy.
DRUG	Placebo oral capsule	The participant will received placebo oral capsule bid for 3 months on top of their regular PAH specific therapy.

Timeline

• Start date: 2017-09-10
• Primary completion: 2018-11-01
• Completion: 2018-12-14
• First posted: 2017-09-06
• Last updated: 2019-10-03
• Results posted: 2019-10-03

Locations

1 site across 1 country: Indonesia