Study Stopped
Several therapeutic have been developed making more difficult the eligibility of patients - Recruitment of new centers wasn't possible due to competing trials
Evaluation of Metformin Activity in Addition to Conventional Treatment of Grade II or III Pulmonary Arterial Hypertension (PAH)
MetHTAP
1 other identifier
interventional
N/A
1 country
2
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.
Trial Health
Trial Health Score
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2 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 10, 2011
CompletedFirst Posted
Study publicly available on registry
May 11, 2011
CompletedAugust 6, 2012
August 1, 2012
May 10, 2011
August 3, 2012
Conditions
Outcome Measures
Primary Outcomes (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.
Study Arms (1)
Metformin
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
- Informed consent signed
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
CHU de Nantes
Nantes, 44093, France
CHU de Bordeaux
Pessac, 33604, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 10, 2011
First Posted
May 11, 2011
Study Start
May 1, 2011
Last Updated
August 6, 2012
Record last verified: 2012-08