Trimetazidine in Pulmonary Artery Hypertension

Pulmonary Artery Hypertension Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02102672
• Other study ID #: 13-229
• 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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Artery Hypertension

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