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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease; Hypertension, Pulmonary
• Intervention / Treatment: Drug: DHEA Treatment; Drug: DHEA Treatment

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Bordeaux, France
    • University Hospital, Bordeaux
  • Limoges, France
    • CHU de Limoges
  • Strasbourg, France
    • CHU de Strasbourg
  • Toulouse, France
    • CHU de Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 200 mg /day arm	Drug: DHEA Treatment; DHEA : 200 mg/day hard gelatine capsule; Drug: DHEA Treatment; DHEA : 25 mg/day hard gelatine capsule
Experimental: 25 mg/day arm	Drug: DHEA Treatment; DHEA : 200 mg/day hard gelatine capsule; Drug: DHEA Treatment; DHEA : 25 mg/day hard gelatine capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Efficacy of DHEA on exercise capacity (six-minute walk test)	inclusion and one year of treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Pulmonary vascular resistances	Inclusion and after one year of treatment
Pulmonary and systemic arterial pressures (mean, systolic and diastolic)	Inclusion and after one year of treatment
Safety / Compliance	along one year of treatment

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2008
• Primary Completion (Actual): June 5, 2015
• Study Completion (Actual): June 5, 2015

Study Registration Dates

• First Submitted: January 7, 2011
• First Submitted That Met QC Criteria: January 7, 2011
• First Posted (Estimate): January 10, 2011

Study Record Updates

• Last Update Posted (Actual): February 9, 2022
• Last Update Submitted That Met QC Criteria: February 8, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: DHEA; Hypertension, pulmonary; six-minute walk test; pulmonary arterial pressure
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Hypertension, Pulmonary; Physiological Effects of Drugs; Immunologic Factors; Adjuvants, Immunologic; Dehydroepiandrosterone
• Other Study ID Numbers: CHUBX 2003/04