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Trimetazidine in Pulmonary Artery Hypertension

Sponsor
Pontificia Universidad Catolica de Chile (Other)
Overall Status
Unknown status
CT.gov ID
NCT02102672
Collaborator
Fondo Nacional de Desarrollo Científico y Tecnológico, Chile (Other)
25
Enrollment
1
Location
2
Arms
45
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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 "

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Study Start Date :
Mar 1, 2014
Anticipated Primary Completion Date :
Dec 1, 2016
Anticipated Study Completion Date :
Dec 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Sugar pill

Placebo 1 pill bid, 3 months
Experimental: Trimetazidine

Trimetazidine 35 mg bid for 3 months

Drug: Trimetazidine
Other Names:
  • Vastarel

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Changes in right ventricular (RV) function [3 months]

      Changes in RV function assessed by echo 3d (strain-strain rate)

    Secondary Outcome Measures

    1. Changes in exercise capacity [3 months]

      Changes in exercise capacity assessed by 6 minute walk test

    2. Changes in symptoms [3 months]

      Changes in Borg dyspnea index

    3. Changes in biomarkers [3 months]

      Changes in B-type natriuretic peptide, galectin-3 and rho-kinase activity

    4. Time to clinical worsening [3 months]

      Time to first PAH related medical event (ER evaluation, hospitalization or death)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Exclusion Criteria:

    • 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

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Clinico Pontificia Universidad Catolica de Chile Santiago Metropolitana Chile 8330024

    Sponsors and Collaborators

    • Pontificia Universidad Catolica de Chile
    • Fondo Nacional de Desarrollo Científico y Tecnológico, Chile

    Investigators

    • Principal Investigator: Pablo F Castro, MD, Pontificia Universidad Catolica de Chile

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pontificia Universidad Catolica de Chile
    ClinicalTrials.gov Identifier:
    NCT02102672
    Other Study ID Numbers:
    • 13-229
    First Posted:
    Apr 3, 2014
    Last Update Posted:
    Apr 3, 2014
    Last Verified:
    Mar 1, 2014
    Additional relevant MeSH terms:
    Pulmonary Arterial Hypertension
    Hypertension
    Trimetazidine

    Study Results

    No Results Posted as of Apr 3, 2014