Pulmonary Artery HypertensionPhase 2NCT02102672
Trimetazidine in Pulmonary Artery Hypertension
A Phase 2 study testing Trimetazidine in people with Pulmonary Artery Hypertension, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial summary
Pulmonary artery hypertension (PAH) is a chronic and progressive disease that affects 15 persons per million. Although current therapy has improve disease prognosis, PAH still has a poor survival, with a median survival of 2.8 years after diagnosis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Artery 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
- 25 participants
- Where
- 1 siteChile
- Study dates
- Mar 2014to Dec 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PAH patients belonging to the following subgroups of the updated Dana Point Classification Group 1
- Idiopathic PAH
- Heritable PAH
- Drug or toxin-induced PAH
- PAH associated with connective tissue disease
- PAH associated to congenital heart disease with simple systemic-to-pulmonary shunt at least 1 year after surgical repair
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- PAH associated to HIV infection
- Documented hemodynamic diagnosis of PAH by right ventricular catheterization performed any time prior to screening
- Signed informed consent
Who cannot join
- Patients belonging to the subgroups of the updated Dana Point Classification Group I not listed in the inclusion criteria
- Patients belonging to the groups 2-5 of the updated Dana Point Classification Group
- Moderate to severe chronic pulmonary obstructive disease
- Documented left ventricular dysfunction
- Severe renal impairment (Serum creatinine > 2.5 mg/dL)
- Patients who are receiving or have been receiving any investigational drugs within 1 month before the baseline visit
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- 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
- Life expectancy less than 12 months
- Females who are lactating or pregnant or those who plan to become pregnant during the study
- Known hypersensitivity to any of the excipients of the drug formulation
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Hospital Clinico Pontificia Universidad Catolica de Chile
Santiago, Santiago Metropolitan, 8330024
Silvana A Llevaneras, RN, +56223548236, sllevane@med.puc.cl
About this study
Official title: Comprehensive Evaluation of Right Ventricular Function, Ventricular Remodeling and Micro RNA Profiling in Pulmonary Artery Hypertension: Effects of a Fatty Acid Oxidation Inhibitor
Pulmonary artery hypertension (PAH) is a chronic and progressive disease that affects 15 persons per million. Although current therapy has improve disease prognosis, PAH still has a poor survival, with a median survival of 2.8 years after diagnosis. In the last few years new key elements in PAH pathogenesis have been discovered, such as the role of metabolism in disease onset and progression. In fact, PAH pulmonary smooth muscle cells switch into a glycolytic phenotype which resembles the metabolism of cancer cells. The investigators hypothesis is that "fatty acid oxidation inhibition reverts the PAH adverse phenotype by restoring mitochondrial function and morphology, decreasing proliferation and restoring apoptosis susceptibility in pulmonary smooth muscle cells "
- Conditions
- Pulmonary Artery Hypertension
- Being tested
- Trimetazidine
- Medical subject headings
- Familial Primary Pulmonary Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrimetazidineDrug
Also called Vastarel
| Study group | Role | What they receive |
|---|---|---|
| Sugar pill | Placebo comparator | Placebo 1 pill bid, 3 months |
| Trimetazidine | Experimental | Trimetazidine 35 mg bid for 3 months Receives: Drug: Trimetazidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in right ventricular (RV) function
Changes in RV function assessed by echo 3d (strain-strain rate)
Measured: 3 months
Secondary outcomes (4)
Changes in exercise capacity
Changes in exercise capacity assessed by 6 minute walk test
Measured: 3 months
Changes in symptoms
Changes in Borg dyspnea index
Measured: 3 months
Changes in biomarkers
Changes in B-type natriuretic peptide, galectin-3 and rho-kinase activity
Measured: 3 months
Time to clinical worsening
Time to first PAH related medical event (ER evaluation, hospitalization or death)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Artery HypertensionStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
- Responsible party
- Sponsor
- Investigators
- Pablo F Castro, MD, Principal investigator, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02102672
- Sponsor's protocol ID
- 13-229
- Status last verified
- Mar 2014
- First submitted
- 31 Mar 2014
- Last updated
- 3 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Evaluation of Right Ventricular Function, Ventricular Remodeling and Micro RNA Profiling in Pulmonary Artery Hypertension: Effects of a Fatty Acid Oxidation Inhibitor
- ClinicalTrials.gov ID
- NCT02102672
- Acronym / sponsor ID
- 13-229
- Conditions
- Pulmonary Artery Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Collaborators
- Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
- Study start
- Mar 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 3 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pulmonary artery hypertension (PAH) is a chronic and progressive disease that affects 15 persons per million. Although current therapy has improve disease prognosis, PAH still has a poor survival, with a median survival of 2.8 years after diagnosis. In the last few years new key elements in PAH pathogenesis have been discovered, such as the role of metabolism in disease onset and progression. In fact, PAH pulmonary smooth muscle cells switch into a glycolytic phenotype which resembles the metabolism of cancer cells. The investigators hypothesis is that "fatty acid oxidation inhibition reverts the PAH adverse phenotype by restoring mitochondrial function and morphology, decreasing proliferation and restoring apoptosis susceptibility in pulmonary smooth muscle cells "
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugar pill | Placebo comparator | –Placebo 1 pill bid, 3 months |
| Trimetazidine | Experimental | Drug: TrimetazidineTrimetazidine 35 mg bid for 3 months |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- PAH patients belonging to the following subgroups of the updated Dana Point Classification Group 1
- Documented hemodynamic diagnosis of PAH by right ventricular catheterization performed any time prior to screening
- Signed informed consent
Key exclusion criteria (11 listed)
- Patients belonging to the subgroups of the updated Dana Point Classification Group I not listed in the inclusion criteria
- Patients belonging to the groups 2-5 of the updated Dana Point Classification Group
- Moderate to severe chronic pulmonary obstructive disease
- Documented left ventricular dysfunction
- Severe renal impairment (Serum creatinine > 2.5 mg/dL)
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: Vastarel | Drug | Trimetazidine |
Primary outcome
Changes in right ventricular (RV) function
Time frame: 3 months
Changes in RV function assessed by echo 3d (strain-strain rate)
4 secondary outcomes
Changes in exercise capacity
Time frame: 3 months
Changes in symptoms
Time frame: 3 months
Changes in biomarkers
Time frame: 3 months
Time to clinical worsening
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2014.
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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.
Pablo F Castro, MD principal investigator
Pontificia Universidad Catolica de Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trimetazidine in people with Pulmonary Artery Hypertension, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
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 9 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 3 Apr 2014. 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 Chile. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pablo F Castro, MD (+56223543334, pcastro@med.puc.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in right ventricular (RV) function (time frame: 3 months). 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 Apr 2014.