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

Status
Withdrawn
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01352026
Acronym
MetHTAP
Enrollment
0
Registered
2011-05-11
Start date
2011-05-31
Completion date
Unknown
Last updated
2012-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Arterial Hypertension

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.

Interventions

DRUGMetformin

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frame
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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026