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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01352026
Recruitment Status : Withdrawn (Several therapeutic have been developed making more difficult the eligibility of patients - Recruitment of new centers wasn't possible due to competing trials)
First Posted : May 11, 2011
Last Update Posted : August 6, 2012
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: Metformin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Study Start Date : May 2011

Arm Intervention/treatment
Experimental: Metformin Drug: Metformin

Primary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01352026

CHU de Nantes
Nantes, France, 44093
CHU de Bordeaux
Pessac, France, 33604
Sponsors and Collaborators
Nantes University Hospital Identifier: NCT01352026     History of Changes
Other Study ID Numbers: BRD10/6-V
First Posted: May 11, 2011    Key Record Dates
Last Update Posted: August 6, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Hypoglycemic Agents
Physiological Effects of Drugs