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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02102672
Other study ID # 13-229
Secondary ID
Status Recruiting
Phase Phase 2
First received March 31, 2014
Last updated April 2, 2014
Start date March 2014
Est. completion date December 2017

Study information

Verified date March 2014
Source Pontificia Universidad Catolica de Chile
Contact Pablo F Castro, MD
Phone +56223543334
Email pcastro@med.puc.cl
Is FDA regulated No
Health authority Chile: Instituto de Salud Pública de ChileChile: Comisión Nacional de Investigación Científica y Tecnológica
Study type Interventional

Clinical 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. 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 "


Recruitment information / eligibility

Status Recruiting
Enrollment 25
Est. completion date December 2017
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
Trimetazidine


Locations

Country Name City State
Chile Hospital Clinico Pontificia Universidad Catolica de Chile Santiago Metropolitana

Sponsors (2)

Lead Sponsor Collaborator
Pontificia Universidad Catolica de Chile Fondo Nacional de Desarrollo Científico y Tecnológico, Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in right ventricular (RV) function Changes in RV function assessed by echo 3d (strain-strain rate) 3 months No
Secondary Changes in exercise capacity Changes in exercise capacity assessed by 6 minute walk test 3 months No
Secondary Changes in symptoms Changes in Borg dyspnea index 3 months No
Secondary Changes in biomarkers Changes in B-type natriuretic peptide, galectin-3 and rho-kinase activity 3 months No
Secondary Time to clinical worsening Time to first PAH related medical event (ER evaluation, hospitalization or death) 3 months Yes
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