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

NCT03273387 | Completed Phase 2 Results DMC

• 1 other identifier: LB.02.01/VII/172/KEP.009/2017
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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 patients.

Conditions

Precapillary Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• Changes in Right Ventricular Ejection Fraction (RVEF %) After 3 Months Intervention

  Right ventricular ejection fraction (RVEF %) assessed by Cardiac MRI at 3 months intervention minus with RVEF at baseline.

  Baseline and 3 months after intervention

Secondary Outcomes (2)

• 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

Study Arms (2)

Sugar pill

PLACEBO COMPARATOR

The participant will received placebo oral capsule bid for 3 months on top of their regular PAH specific therapy.

Drug: Placebo oral capsule

trimetazidine

EXPERIMENTAL

The participant will received trimetazidine 35 mg bid for 3 months on top of their regular PAH specific therapy.

Drug: Trimetazidine

Interventions

Trimetazidine DRUG

The participant will received trimetazidine 35 mg bid for 3 months on top of their regular PAH specific therapy.

Also known as: Trizedon MR

trimetazidine

Placebo oral capsule DRUG

The participant will received placebo oral capsule bid for 3 months on top of their regular PAH specific therapy.

Also known as: sugar pill

Sugar pill

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

National Cardiovascular Center Harapan Kita Hospital

Jakarta, 11420, Indonesia

Location

MeSH Terms

Interventions

Trimetazidine; Sugars

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbohydrates

Results Point of Contact

• Title: dr. Bambang WIdyantoro, FIHA, PhD
• Organization: Department of Cardiology and Vascular Medicine, Universitas Indonesia

bambang_ui@yahoo.com

+628128164299

Study Officials

• Hary Sakti Muliawan, MD,PhD

  Department Cardiology and Vascular Medicine Universitas Indonesia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,PhD

Study Record Dates

• First Submitted: September 3, 2017
• First Posted: September 6, 2017
• Study Start: September 10, 2017
• Primary Completion: November 1, 2018
• Study Completion: December 14, 2018
• Last Updated: October 3, 2019
• Results First Posted: October 3, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)