NCT02102672

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 "

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2014

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 31, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 3, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 3, 2014

Status Verified

March 1, 2014

Enrollment Period

2.8 years

First QC Date

March 31, 2014

Last Update Submit

April 2, 2014

Conditions

Pulmonary Artery Hypertension

Outcome Measures

Primary Outcomes (1)

  • Changes in right ventricular (RV) function

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

    3 months

Secondary Outcomes (4)

  • Changes in exercise capacity

    3 months

  • Changes in symptoms

    3 months

  • Changes in biomarkers

    3 months

  • Time to clinical worsening

    3 months

Study Arms (2)

Sugar pill

PLACEBO COMPARATOR

Placebo 1 pill bid, 3 months

Trimetazidine

EXPERIMENTAL

Trimetazidine 35 mg bid for 3 months

Drug: Trimetazidine

Interventions

TrimetazidineDRUG
Also known as: Vastarel
Trimetazidine

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinico Pontificia Universidad Catolica de Chile

Santiago, Santiago Metropolitan, 8330024, Chile

RECRUITING

MeSH Terms

Conditions

Familial Primary Pulmonary Hypertension

Interventions

Trimetazidine

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Pablo F Castro, MD

    Pontificia Universidad Catolica de Chile

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pablo F Castro, MD

CONTACT

+56223543334pcastro@med.puc.cl

Hugo E Verdejo, MD, PhD

CONTACT

+569223543624hverdejo@med.puc.cl

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2014

First Posted

April 3, 2014

Study Start

March 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2017

Last Updated

April 3, 2014

Record last verified: 2014-03

Locations

CL(1)