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

Primary Purpose

Chronic Obstructive Pulmonary Disease, Hypertension, Pulmonary

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
DHEA Treatment
DHEA Treatment
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Hypertension, pulmonary, DHEA, six-minute walk test, pulmonary arterial pressure

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

200 mg /day arm

25 mg/day arm

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pulmonary and systemic arterial pressures (mean, systolic and diastolic)
Pulmonary vascular resistances
Safety / Compliance

Full Information

First Posted
January 7, 2011
Last Updated
February 8, 2022
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT01273259
Brief Title
Study of Dehydroepiandrosterone (DHEA) in Respiratory Pulmonary Hypertension in Adults
Official Title
Study of Dehydroepiandrosterone (DHEA) in Respiratory Pulmonary Hypertension in Adults. Phase 2 Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
May 6, 2008 (Actual)
Primary Completion Date
June 5, 2015 (Actual)
Study Completion Date
June 5, 2015 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Hypertension, Pulmonary
Keywords
Hypertension, pulmonary, DHEA, six-minute walk test, pulmonary arterial pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
200 mg /day arm
Arm Type
Experimental
Arm Title
25 mg/day arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
DHEA Treatment
Intervention Description
DHEA : 200 mg/day hard gelatine capsule
Intervention Type
Drug
Intervention Name(s)
DHEA Treatment
Intervention Description
DHEA : 25 mg/day hard gelatine capsule
Primary Outcome Measure Information:
Title
Efficacy of DHEA on exercise capacity (six-minute walk test)
Time Frame
inclusion and one year of treatment
Secondary Outcome Measure Information:
Title
Pulmonary and systemic arterial pressures (mean, systolic and diastolic)
Time Frame
Inclusion and after one year of treatment
Title
Pulmonary vascular resistances
Time Frame
Inclusion and after one year of treatment
Title
Safety / Compliance
Time Frame
along one year of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University Hospital, Bordeaux
City
Bordeaux
Country
France
Facility Name
CHU de Limoges
City
Limoges
Country
France
Facility Name
CHU de Strasbourg
City
Strasbourg
Country
France
Facility Name
CHU de Toulouse
City
Toulouse
Country
France

12. IPD Sharing Statement

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

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