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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by University Hospital, Bordeaux.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01273259
First received: January 7, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Hypertension, Pulmonary
Drug: DHEA Treatment
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Dehydroepiandrosterone (DHEA) in Respiratory Pulmonary Hypertension in Adults. Phase 2 Trial

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Efficacy of DHEA on exercise capacity (six-minute walk test) [ Time Frame: inclusion and one year of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pulmonary and systemic arterial pressures (mean, systolic and diastolic) [ Time Frame: Inclusion and after one year of treatment ] [ Designated as safety issue: No ]
  • Pulmonary vascular resistances [ Time Frame: Inclusion and after one year of treatment ] [ Designated as safety issue: No ]
  • Safety / Compliance [ Time Frame: along one year of treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 8
Study Start Date: January 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 200 mg /day arm Drug: DHEA Treatment
DHEA : 200 mg/day hard gelatine capsule
Experimental: 25 mg/day arm Drug: DHEA Treatment
DHEA : 25 mg/day hard gelatine capsule

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01273259

Contacts
Contact: Eric Dumas De La Roque, Dr eric.dumas-de-la-roque@chu-bordeaux.fr
Contact: Fabienne Nacka, phD fabienne.nacka@chu-bordeaux.fr

Locations
France
University Hospital, Bordeaux Recruiting
Bordeaux, France
Principal Investigator: Claire Dromer, Dr         
Sub-Investigator: Douard, Pr         
Sub-Investigator: Marc Billes, Dr         
Sub-Investigator: Rean, Dr         
Principal Investigator: Benissan, Pr         
Sub-Investigator: Bui, Dr         
CHU de Limoges
Limoges, France
CHU de Strasbourg
Strasbourg, France
CHU de Toulouse
Toulouse, France
Sponsors and Collaborators
University Hospital, Bordeaux
  More Information

No publications provided

Responsible Party: Jean-Pierre LEROY / Clinical Research and Innovation Director, University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01273259     History of Changes
Other Study ID Numbers: CHUBX 2003/04
Study First Received: January 7, 2011
Last Updated: January 7, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
Hypertension, pulmonary
DHEA
six-minute walk test
pulmonary arterial pressure

Additional relevant MeSH terms:
Hypertension
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Respiratory Tract Diseases
Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014