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

NCT ID: NCT01352026

Last Updated: 2012-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Brief Summary

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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 Description

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Conditions

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Pulmonary Arterial Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Metformin

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

Interventions

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Metformin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Locations

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CHU de Nantes

Nantes, , France

Site Status

CHU de Bordeaux

Pessac, , France

Site Status

Countries

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France

Other Identifiers

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BRD10/6-V

Identifier Type: -

Identifier Source: org_study_id