Evaluation of Metformin Activity in Addition to Conventional Treatment of Grade II or III Pulmonary Arterial Hypertension (PAH)
- Registration Number
- NCT01352026
- Lead Sponsor
- Nantes University Hospital
- 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 Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Metformin Metformin -
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
CHU de Nantes
🇫🇷Nantes, France
CHU de Bordeaux
🇫🇷Pessac, France