Study of Dehydroepiandrosterone (DHEA) in Respiratory Pulmonary Hypertension in Adults

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Study of Dehydroepiandrosterone (DHEA) in Respiratory Pulmonary Hypertension in Adults. Phase 2 Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01273259
• Other study ID #: CHUBX 2003/04
• Status: Completed
• Phase: Phase 2
• Start date: May 6, 2008
• Est. completion date: June 5, 2015

Study information

• Verified date: February 2022
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: June 5, 2015
• Est. primary completion date: June 5, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age = 18 years old and = 75 years old

• Chronic Obstructive Pulmonary Disease with FEVs/VC < 70% (*)

• Respiratory pulmonary hypertension with mean pulmonary arterial pressure = 20 mmHg (*) related to normal pulmonary capillar pressure assessed by catheterization of the right side of the heart (pulmonary capillary wedge pressure =12mmHg)

• PO2 = 70 mmHg assessed by arterial gasometry at ease

• If oxygenotherapy then oxygenotherapy more than 6 months before pre-screening

• Written informed consent

(*) Criteria assessed from last health check or the last exams for COPD diagnosis

Exclusion Criteria:

• clinical instability and/or respiratory exacerbation dangerous for catheterization

• Pregnancy (ßHCG > 20 UI /l) or breastfeeding on going

• General corticotherapy > 0,5 mg/kg/day prednisolon equivalent

• Hepatic insufficiency (TP < 50%) or renal insufficiency (creatininemia > 130 µmol/l) or diabetes mellitus type I or II (treated by oral antidiabetic or insulin)

• Left-heart failure (coronary heart disease and/or left valvulopathy)

• High level of prostatic specific antigen (PSA) (> 7ng/ml)

• Cancer antecedent or treatment on going

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Hypertension
• Hypertension, Pulmonary
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• DHEA Treatment
DHEA : 200 mg/day hard gelatine capsule
• DHEA Treatment
DHEA : 25 mg/day hard gelatine capsule

Locations

Country	Name	City	State
France	University Hospital, Bordeaux	Bordeaux
France	CHU de Limoges	Limoges
France	CHU de Strasbourg	Strasbourg
France	CHU de Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of DHEA on exercise capacity (six-minute walk test)		inclusion and one year of treatment
Secondary	Pulmonary and systemic arterial pressures (mean, systolic and diastolic)		Inclusion and after one year of treatment
Secondary	Pulmonary vascular resistances		Inclusion and after one year of treatment
Secondary	Safety / Compliance		along one year of treatment