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| ID | Type | Description | Link |
|---|---|---|---|
| 040479 | Other Identifier | ANSM |
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DHEA prevents and reverses chronic hypoxic pulmonary hypertension in a chronic hypoxic-pulmonary hypertension model in the rat. However, no study has been performed in human. The purpose of this study is to determine if DHEA is effective in the treatment of respiratory pulmonary hypertension in adults with Chronic Obstructive Pulmonary Disease (COPD) on exercise capacity and haemodynamic variables. Patients will receive after randomisation either 25 mg/day or 200mg/day oral DHEA over a one-year period. Evaluation concerns clinical parameters, echocardiography and right catheterization after and before treatment. Primary end-point is the six-minute walk test. This is a prospective double blind, randomised, placebo controlled study which will be realized in four university hospitals in France : Bordeaux, Strasbourg, Toulouse and Limoges.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 200 mg /day arm | Experimental |
| |
| 25 mg/day arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DHEA Treatment | Drug | DHEA : 200 mg/day hard gelatine capsule |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of DHEA on exercise capacity (six-minute walk test) | inclusion and one year of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary and systemic arterial pressures (mean, systolic and diastolic) | Inclusion and after one year of treatment | |
| Pulmonary vascular resistances | Inclusion and after one year of treatment | |
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Inclusion Criteria:
(*) Criteria assessed from last health check or the last exams for COPD diagnosis
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital, Bordeaux | Bordeaux | France | ||||
| CHU de Limoges |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22280813 | Result | Dumas de La Roque E, Savineau JP, Metivier AC, Billes MA, Kraemer JP, Doutreleau S, Jougon J, Marthan R, Moore N, Fayon M, Baulieu EE, Dromer C. Dehydroepiandrosterone (DHEA) improves pulmonary hypertension in chronic obstructive pulmonary disease (COPD): a pilot study. Ann Endocrinol (Paris). 2012 Feb;73(1):20-5. doi: 10.1016/j.ando.2011.12.005. Epub 2012 Jan 26. |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| DHEA Treatment |
| Drug |
DHEA : 25 mg/day hard gelatine capsule |
|
| Safety / Compliance |
| along one year of treatment |
| Limoges |
| France |
| CHU de Strasbourg | Strasbourg | France |
| CHU de Toulouse | Toulouse | France |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |