Trimetazidine in Pulmonary Artery Hypertension

NCT ID: NCT02102672

Last Updated: 2014-04-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2017-12-31

Brief 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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Sugar pill

Placebo 1 pill bid, 3 months

Group Type: PLACEBO_COMPARATOR

No interventions assigned to this group

Trimetazidine

Trimetazidine 35 mg bid for 3 months

Group Type: EXPERIMENTAL

Trimetazidine

Intervention Type: DRUG

Interventions

Trimetazidine

Intervention Type: DRUG

Other Intervention Names

Vastarel

Eligibility Criteria

Inclusion Criteria

• PAH patients belonging to the following subgroups of the updated Dana Point Classification Group 1

1. Idiopathic PAH

2. Heritable PAH

3. Drug or toxin-induced PAH

4. PAH associated with connective tissue disease

5. PAH associated to congenital heart disease with simple systemic-to-pulmonary shunt at least 1 year after surgical repair

6. PAH associated to HIV infection

• Documented hemodynamic diagnosis of PAH by right ventricular catheterization performed any time prior to screening
• Signed informed consent

• 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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondo Nacional de Desarrollo Científico y Tecnológico, Chile

OTHER_GOV

Sponsor Role: collaborator

Pontificia Universidad Catolica de Chile

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pablo F Castro, MD

Role: PRINCIPAL_INVESTIGATOR

Pontificia Universidad Catolica de Chile

Locations

Hospital Clinico Pontificia Universidad Catolica de Chile

Santiago, Santiago Metropolitan, Chile

Site Status: RECRUITING

Countries

Chile

Central Contacts

Pablo F Castro, MD

Role: CONTACT

pcastro@med.puc.cl

+56223543334

Hugo E Verdejo, MD, PhD

Role: CONTACT

hverdejo@med.puc.cl

+569223543624

Facility Contacts

Silvana A Llevaneras, RN

Role: primary

sllevane@med.puc.cl

+56223548236

Other Identifiers

13-229

Identifier Type: -

Identifier Source: org_study_id