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Dichloroacetate (DCA) for the Treatment of Pulmonary Arterial Hypertension

NCT01083524 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2014-06-03

No results posted yet for this study

Summary

Hypothesis: The small molecule and metabolic modulator Dichloroacetate (DCA) is safe, tolerated as a potential therapy in patients with moderate or severe Pulmonary Arterial Hypertension (PAH).

This is a Phase I, two centre study in subjects with PAH WHO functional class III-IV whose symptoms have been clinically stable on their prescribed medical treatment (which includes endothelin and/or phosphodiesterase type 5 inhibitors) for 8 weeks prior to enrollment. Such patients will be given either DCA 3.0 mg/kg BID (group I), 6.25 mg/kg BID (group II) or 12.5 mg/kg BID (group III) as an additional treatment for 16 weeks. The design is open-label with the subjects acting as their own controls.

Primary endpoint is the safety and tolerability of DCA. Secondary end points include: a) functional capacity including a change in the 6 minute walk form baseline, b) change in pulmonary vascular resistance (measured by right heart catheterization), c) right ventricular volumes and mass (measured by MRI), d) NT-proBNP levels changed from baseline, e) change in FDG-glucose uptake in the lung and right ventricle (measured by PET) and f) change in quality of life indices.

15 evaluable patients in each site are expected to be included.

Conditions

  • Pulmonary Hypertension (Idiopathic, Familial or Anorexigen-associated)

Interventions

DRUG

Dichloroacetate Sodium

3 mg po bid for 28 weeks

DRUG

Dichloroacetate Sodium

6.25 mg po bid

DRUG

Dichloroacetate Sodium

12.5 mg po bid

Sponsors & Collaborators

  • Imperial College London

    collaborator OTHER

  • University of Alberta

    lead OTHER

Principal Investigators

  • Evangelos D. Michelakis, MD · University of Alberta

  • Martin R Wilkins, MD · Imperial College London

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • Canada
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01083524 on ClinicalTrials.gov