Phase 3
Completed N=26
The Role of Trimetazidine on Right Ventricle Function in Pulmonary Arterial Hypertension
Precapillary Pulmonary Hypertension
Source: ClinicalTrials.gov NCT03273387 ↗
Enrolled (actual)
26
Serious AEs
15.4%
Results posted
Oct 2019
Primary outcomePrimary: Changes in Right Ventricular Ejection Fraction (RVEF %) After 3 Months Intervention — -2.8; 3.9 percentage of ejected blood — p=0.008
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Right Ventricular Ejection Fraction (RVEF %) After 3 Months Intervention |
-2.8; 3.9 | 0.008 sig |
| SECONDARY Changes in Cardiac Fibrosis After 3 Months Intervention |
138; 190; 292; 371; 294; -123 | 0.33 |
| SECONDARY Changes in Functional Capacity After 3 Month Intervention |
-17.73; 11.5 | 0.0002 sig |
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT03273387). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.