Status:
COMPLETED
The Role of Trimetazidine on Right Ventricle Function in Pulmonary Arterial Hypertension
Lead Sponsor:
Indonesia University
Conditions:
Precapillary Pulmonary Hypertension
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief 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 patie...
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 ven...
Eligibility Criteria
Inclusion
- Pre-capillary Pulmonary Hypertension patients assessed by right heart catheterization
- Signed informed consent
Exclusion
- 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
Key Trial Info
Start Date :
September 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 14 2018
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT03273387
Start Date
September 10 2017
End Date
December 14 2018
Last Update
October 3 2019
Active Locations (1)
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1
National Cardiovascular Center Harapan Kita Hospital
Jakarta, Indonesia, 11420