Evaluation of Metformin Activity in Addition to Conventional Treatment of Grade II or III Pulmonary Arterial Hypertension (PAH)

Overview[ - collapse ][ - ]

Purpose Treatment of PAH includes exercise limitation, non specific agents (anticoagulants, diuretics and supplemental oxygen), pulmonary specific vasodilators and antiproliferative agents. Recent data obtained by our group, within rat PAH models, showed that the antihyperglycemic drug metformin, used in France since 1959 in diabetic type II patients, significantly acts at the pulmonary arteries level. According to these results, and knowing that metformin is a widely used drug, with a favorable safety profile, the investigators decided to set up a pilot study, in order to evaluate the activity of metformin in PAH treatment. In parallel, the investigators will focus on metformin mechanism of action.
ConditionPulmonary Arterial Hypertension
InterventionDrug: Metformin
PhasePhase 2
SponsorNantes University Hospital
Responsible PartyNantes University Hospital
ClinicalTrials.gov IdentifierNCT01352026
First ReceivedMay 10, 2011
Last UpdatedAugust 3, 2012
Last verifiedAugust 2012

Tracking Information[ + expand ][ + ]

First Received DateMay 10, 2011
Last Updated DateAugust 3, 2012
Start DateMay 2011
Estimated Primary Completion DateNot Provided
Current Primary Outcome MeasuresThe primary objective of this study will be to demonstrate the improvement of walk test distance in patients with pulmonary arterial hypertension (PAH) treated by metformin.
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitleEvaluation of Metformin Activity in Addition to Conventional Treatment of Grade II or III Pulmonary Arterial Hypertension (PAH)
Official TitleNot Provided
Brief Summary
Treatment of PAH includes exercise limitation, non specific agents (anticoagulants,
diuretics and supplemental oxygen), pulmonary specific vasodilators and antiproliferative
agents.

Recent data obtained by our group, within rat PAH models, showed that the antihyperglycemic
drug metformin, used in France since 1959 in diabetic type II patients, significantly acts
at the pulmonary arteries level.

According to these results, and knowing that metformin is a widely used drug, with a
favorable safety profile, the investigators decided to set up a pilot study, in order to
evaluate the activity of metformin in PAH treatment. In parallel, the investigators will
focus on metformin mechanism of action.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 2
Study DesignIntervention Model: Single Group Assignment, Masking: Open Label
ConditionPulmonary Arterial Hypertension
InterventionDrug: Metformin
Study Arm (s)Experimental: Metformin

Recruitment Information[ + expand ][ + ]

Recruitment StatusWithdrawn
Estimated EnrollmentNot Provided
Estimated Completion DateNot Provided
Estimated Primary Completion DateNot Provided
Eligibility Criteria
Inclusion Criteria:

- Men or women aged between 18 and 80

- Patients included will have pre-capillary PAH

- they have to be stable for more than 3 months

- Patient with a 6-minute walk test comparable over the last 3 months before inclusion

- Informed consent signed
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesFrance

Administrative Information[ + expand ][ + ]

NCT Number NCT01352026
Other Study ID NumbersBRD10/6-V
Has Data Monitoring CommitteeNot Provided
Information Provided ByNantes University Hospital
Study SponsorNantes University Hospital
CollaboratorsNot Provided
Investigators Not Provided
Verification DateAugust 2012

Locations[ + expand ][ + ]

CHU de Nantes
Nantes, France, 44093
CHU de Bordeaux
Pessac, France, 33604