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The Role of Trimetazidine on Right Ventricle Function in Pulmonary Arterial Hypertension in National Cardiovascular Center Harapan Kita Hospital (TRIMETA-PH)

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ClinicalTrials.gov Identifier: NCT03273387
Recruitment Status : Recruiting
First Posted : September 6, 2017
Last Update Posted : September 6, 2017
Sponsor:
Information provided by (Responsible Party):
Hary Sakti Muliawan, MD, PhD, Indonesia University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Precapillary Pulmonary Hypertension Drug: Trimetazidine Drug: Placebo oral capsule Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Role of Trimetazidine on Right Ventricle Function in Pulmonary Arterial Hypertension Patients in National Cardiovascular Center Harapan Kita Hospital Indonesia
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : June 1, 2018
Estimated Study Completion Date : October 1, 2018


Arm Intervention/treatment
Placebo Comparator: Sugar pill
The participant will received placebo oral capsule 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.
Other Name: sugar pill

Experimental: trimetazidine
The participant will received trimetazidine 35 mg bid for 3 months on top of their regular PAH specific therapy.
Drug: Trimetazidine
The participant will received trimetazidine 35 mg bid for 3 months on top of their regular PAH specific therapy.
Other Name: Trizedon MR




Primary Outcome Measures :
  1. Changes in right ventricular (RV) function [ Time Frame: 3 months ]
    Changes in RV function assessed by Cardiac MRI


Secondary Outcome Measures :
  1. Changes in Cardiac Fibrosis level [ Time Frame: 3 months ]
    Changes in Native T1 mapping and extracellular volume fraction assessed by Cardiac MRI

  2. Changes in symptoms [ Time Frame: 3 months ]
    Changes in NYHA functional class

  3. Changes in biomarker [ Time Frame: 3 months ]
    Changes in Lactate Dehydrogenase level



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • Documented left ventricular dysfunction
  • Severe renal impairment (Serum creatinine > 2.5 mg/dL, eGFR < 30ml/min/1.73m3, 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 excipients of the drug formulation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03273387


Contacts
Contact: Hary Sakti Muliawan, MD, PhD +6281311666626 saqti1@gmail.com
Contact: Bambang Budi Siswanto, MD,PhD +62816924957 bambbs@gmail.com

Locations
Indonesia
National Cardiovascular Center Harapan Kita Hospital Recruiting
Jakarta, Indonesia, 11420
Contact: Hary Sakti Muliawan, MD, PhD    +6281311666626    saqti1@gmail.com   
Contact: Bambang Budi Siswanto, MD, PhD    +62816924957    bambbs@gmail.com   
Principal Investigator: Hary Sakti Muliawan, MD, PhD         
Sponsors and Collaborators
Indonesia University
Investigators
Principal Investigator: Hary Sakti Muliawan, MD,PhD Resident of Department Cardiology and Vascular Medicine, Faculty of Medicine, Universitas Indonesia

Responsible Party: Hary Sakti Muliawan, MD, PhD, MD,PhD, Indonesia University
ClinicalTrials.gov Identifier: NCT03273387     History of Changes
Other Study ID Numbers: LB.02.01/VII/172/KEP.009/2017
First Posted: September 6, 2017    Key Record Dates
Last Update Posted: September 6, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Trimetazidine
Vasodilator Agents