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

NCT01273259 | Completed Phase 2

• 1 other identifier: CHUBX 2003/04
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Hypertension, Pulmonary; Chronic Obstructive Pulmonary Disease

Keywords

Hypertension, pulmonary; DHEA; six-minute walk test; pulmonary arterial pressure

Outcome Measures

Primary Outcomes (1)

• Efficacy of DHEA on exercise capacity (six-minute walk test)

  inclusion and one year of treatment

Secondary Outcomes (3)

• 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

• Safety / Compliance

  along one year of treatment

Study Arms (2)

200 mg /day arm

EXPERIMENTAL

Drug: DHEA Treatment

25 mg/day arm

EXPERIMENTAL

Drug: DHEA Treatment

Interventions

DHEA Treatment DRUG

DHEA : 200 mg/day hard gelatine capsule

200 mg /day arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (4)

University Hospital, Bordeaux

Bordeaux, France

Location

CHU de Limoges

Limoges, France

Location

CHU de Strasbourg

Strasbourg, France

Location

CHU de Toulouse

Toulouse, France

Location

Related Publications (1)

• 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.

  PMID: 22280813 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2011
• First Posted: January 10, 2011
• Study Start: May 6, 2008
• Primary Completion: June 5, 2015
• Study Completion: June 5, 2015
• Last Updated: May 14, 2026

Record last verified: 2022-02

Locations

FR (4)