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

Phase 2WithdrawnNCT01352026

Nantes University Hospital

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Masking

NONE

Conditions

Pulmonary Arterial Hypertension

Interventions

MetforminDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (2)

CHU de Nantes

Nantes, France

CHU de Bordeaux

Pessac, France

Outcomes

Primary Outcomes

The 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.

Data from ClinicalTrials.gov

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