Precapillary Pulmonary HypertensionPhase 2/3TRIMETA-PHNCT03273387
The Role of Trimetazidine on Right Ventricle Function in Pulmonary Arterial Hypertension
A Phase 2/3 study testing Trimetazidine in people with Precapillary Pulmonary Hypertension, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Precapillary Pulmonary Hypertension
- What is being tested?
- Trimetazidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteIndonesia
- Study dates
- 10 Sep 2017to 14 Dec 2018
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pre-capillary Pulmonary Hypertension patients assessed by right heart catheterization
- Signed informed consent
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
National Cardiovascular Center Harapan Kita Hospital
Jakarta, 11420
About this study
Official title: The Role of Trimetazidine on Right Ventricle Function in Pulmonary Arterial Hypertension Patients in National Cardiovascular Center Harapan Kita Hospital Indonesia
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.
Read the 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
- Being tested
- Trimetazidine, Placebo oral capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrimetazidineDrug
Also called Trizedon MR
The participant will received trimetazidine 35 mg bid for 3 months on top of their regular PAH specific therapy.
Placebo oral capsuleDrug
Also called sugar pill
The participant will received placebo oral capsule bid for 3 months on top of their regular PAH specific therapy.
| Study group | Role | What they receive |
|---|---|---|
| Sugar pill | Placebo comparator | The participant will received placebo oral capsule bid for 3 months on top of their regular PAH specific therapy. Receives: 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. Receives: Drug: Trimetazidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 3 months after intervention
Secondary outcomes (2)
Changes in Cardiac Fibrosis After 3 Months Intervention
Native T1 mapping (ms) assessed by Cardiac MRI at 3 months intervention minus with Native T1 at baseline.
Measured: Baseline and 3 months after intervention
Changes in Functional Capacity After 3 Month Intervention
Functional capacity assessed by SF-36 score after 3 month intervention minus with functional capacity at baseline.
SF-36 functional capacity score scale 0 to 100 with better functional capacity along with higher score.
Measured: Baseline and 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study start10 Sep 2017
- Primary completion1 Nov 2018
- Study completion14 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Precapillary Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hary Sakti Muliawan, MD, PhD, Universitas Indonesia
- Investigators
- Hary Sakti Muliawan, MD,PhD, Principal investigator, Department Cardiology and Vascular Medicine Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03273387
- Sponsor's protocol ID
- LB.02.01/VII/172/KEP.009/2017
- Acronym
- TRIMETA-PH
- Status last verified
- Sep 2019
- First submitted
- 3 Sep 2017
- Last updated
- 3 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Trimetazidine on Right Ventricle Function in Pulmonary Arterial Hypertension Patients in National Cardiovascular Center Harapan Kita Hospital Indonesia
- ClinicalTrials.gov ID
- NCT03273387
- Acronym / sponsor ID
- TRIMETA-PH / LB.02.01/VII/172/KEP.009/2017
- Conditions
- Precapillary Pulmonary Hypertension
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 10 Sep 2017 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 14 Dec 2018 (actual)
- First posted
- 6 Sep 2017 (actual)
- Results
- Posted 3 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugar pill | Placebo comparator | Drug: Placebo oral capsuleThe participant will received placebo oral capsule bid for 3 months on top of their regular PAH specific therapy. |
| trimetazidine | Experimental | Drug: TrimetazidineThe participant will received trimetazidine 35 mg bid for 3 months on top of their regular PAH specific therapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pre-capillary Pulmonary Hypertension patients assessed by right heart catheterization
- Signed informed consent
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrimetazidineAlso: Trizedon MRThe participant will received trimetazidine 35 mg bid for 3 months on top of their regular PAH specific therapy. | Drug | trimetazidine |
| Placebo oral capsuleAlso: sugar pillThe participant will received placebo oral capsule bid for 3 months on top of their regular PAH specific therapy. | Drug | Sugar pill |
Primary outcome
Changes in Right Ventricular Ejection Fraction (RVEF %) After 3 Months Intervention
Time frame: Baseline and 3 months after intervention
Right ventricular ejection fraction (RVEF %) assessed by Cardiac MRI at 3 months intervention minus with RVEF at baseline.
2 secondary outcomes
Changes in Cardiac Fibrosis After 3 Months Intervention
Time frame: Baseline and 3 months after intervention
Changes in Functional Capacity After 3 Month Intervention
Time frame: Baseline and 3 months after intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Precapillary Pulmonary Hypertension
Not yet recruitingPhase 3
A Clinical Study of Sotatercept (MK-7962) in People With Combined Postcapillary and Precapillary Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction (MK-7962-041)
Pulmonary Hypertension
Not yet recruitingPhase 1/2
TEPH: Telaglenastat Efficacy in Pulmonary Hypertension
Pulmonary Hypertension
Active, not recruitingPhase 2
Extension Study of Sotatercept in People With Pulmonary Hypertension (MK-7962-023)
Hypertension, Pulmonary
Not yet recruitingObservational study
Correlation Between CT Pulmonary Angiography Metrics and Right Heart Catheterization Parameters in Pre-Capillary Pulmonary Hypertension
Pulmonary Hypertension, Precapillary Pulmonary Hypertension
Not yet recruiting
Evolution of Hypoxic Burden and Sympathetic/Parasympathetic Balance in Patients With Pulmonary Hypertension
Precapillary Pulmonary Hypertension, Pulmonary Arterial Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hary Sakti Muliawan, MD,PhD principal investigator
Department Cardiology and Vascular Medicine Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Trimetazidine in people with Precapillary Pulmonary Hypertension, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Right Ventricular Ejection Fraction (RVEF %) After 3 Months Intervention (time frame: Baseline and 3 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2019.