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

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ClinicalTrials.gov Identifier: NCT00581087
Recruitment Status : Unknown
Verified January 2015 by University Hospital, Bordeaux.
Recruitment status was:  Active, not recruiting
First Posted : December 27, 2007
Last Update Posted : January 14, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Tracking Information
First Submitted Date  ICMJE December 26, 2007
First Posted Date  ICMJE December 27, 2007
Last Update Posted Date January 14, 2015
Study Start Date  ICMJE January 2007
Estimated Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 26, 2007)
six-minute walk test [ Time Frame: inclusion and one year of treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 26, 2007)
  • Pulmonary and systemic arterial pressures (mean, systolic and diastolic) [ Time Frame: Inclusion and one after year of treatment ]
  • Pulmonary vascular resistances [ Time Frame: Inclusion and after one year of treatment ]
  • Safety [ Time Frame: along one year of treatment ]
  • Compliance [ Time Frame: Along one year of treatment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Dehydroepiandrosterone (DHEA) in Respiratory Pulmonary Hypertension in Adults
Official Title  ICMJE Double-blind, Randomised, Placebo-controlled Phase III Study of Dehydroepiandrosterone (DHEA) in Respiratory Pulmonary Hypertension in Adults
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 randomization either 200 mg oral DHEA or placebo 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, randomized, placebo controlled study which will be realized in four university hospitals in France : Bordeaux, Strasbourg, Toulouse and Limoges.

Eight patients with pulmonary hypertension (New York Heart Association functional class III or IV) associated with COPD were included in a pilot study between 2004 and 2005. Inclusion criteria were: COPD was defined by FEV1/FVC < 70% of reference values; resting mean pulmonary artery pressure (assessment by right pulmonary catheterization) ≥ 25mmHg with mean pulmonary capillary wedge pressure ≤ 15mmHg, PaO2 ≤ 60mmHg at rest or PaO2 ≥ 60mmHg associated with significant fall in O2 saturation with exercise; oxygen treatment initiated more than six months previously. Exclusion criteria were: clinical or respiratory instability during the three months before the inclusion in the study; corticosteroids therapy (> 0.5mg/kg/day of prednisolone or as equivalent); hepatic (prothrombin time < 50%) or renal (creatininemia > 130µmol/L) failure; diabetes; left ventricular dysfunction; PSA (prostatic antigens > 2,5ng/ml) and past history or diagnosis of cancer. The study was conducted in accordance with the Good Clinical Practices Guidelines. The study protocol was approved by the ethics review board of the University Hospital of Bordeaux (France). Written informed consent was obtained for all patients and investigations were conducted according to the institutional guidelines and to the Helsinki principles. This trial conducted enrollment between 2004 and 2005, but had not been registered in ClinicalTrials.gov because it preceded this policy.(Study design: The dose of oral DHEA administered was 200 mg once daily for three months. At baseline and after three months of treatment, clinical evaluation included 6MWT, Borg dyspnea index, systolic and diastolic blood pressure, right heart catheterisation, lung function testing and serum DHEA levels were performed.)

Detailed Description

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

  • Secondary Objective :

    • Efficacy of DHEA on pulmonary arterial pressures (mean, systolic and diastolic), on systemic arterial pressures, pulmonary vascular resistances
    • Safety of DHEA treatment
    • Observance of treatment by DHEA
  • Study design :

Double-blind, randomized, placebo-controlled Phase III study. Patients will be randomized into two parallel groups to receive either 200 mg oral DHEA or placebo over a one-year treatment. This is a multicentric study in the departments of respiratory medicine of Bordeaux, Strasbourg, Limoges and Toulouse (France).

• Inclusion criteria :

  • Age ≥ 18 years old and ≤ 75 years old (*)
  • Chronic Obstructive Pulmonary Disease with VEMS/CV < 70% ( **)
  • Respiratory pulmonary hypertension with mean pulmonary arterial pressure ≥ 25 mmHg (**) related to normal pulmonary capillary pressure assessed by catheterization of the right side of the heart (pulmonary capillary wedge pressure ≤12mmHg)
  • PO2 ≤ 60 mmHg assessed by arterial gazometry at ease (**) or PO2 > 60 mmHg, but related with high hypoxemia after exercise (six-minute walk test )
  • Oxygenotherapy more than 6 months before pre-screening
  • Written informed consent

(*) Inclusion of young adults concerns COPD related to asthma or cystic fibrosis (**) Criteria assessed from last health check or the last exams for COPD diagnosis

  • Exclusion criteria :

    • Clinical instability and/or respiratory exacerbation within the previous three months
    • Clinical instability and/or respiratory exacerbation dangerous for catheterization
    • Pregnancy (ßHCG > 20 UI /l) or breastfeeding on going
    • General corticotherapy > 0,5 mg/kg/j prédnisolone equivalent
    • Hepatic insufficiency (TP < 50%) or renal insufficiency (creatininemia > 130 µmol/l) or diabetes mellitus type I or II (treated by oral antidiabetic oral or insulin)
    • Left-heart failure (coronary heart disease and/or left valvulopathy)
    • High level of prostatic specific antigen (PSA) (> 2,5ng/ml)
    • Previous cancer or treatment on going
  • Study plan:

After the screening evaluation and written consent document, patients will be randomized into two groups placebo or DHEA, over a one year treatment.

• Number of subjects : 60 patients based on the increase of 30 % of the primary end-point, (six-minute walk test), i.e., 30 patients will be included in each group.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Obstructive Pulmonary Disease
  • Hypertension, Pulmonary
Intervention  ICMJE
  • Drug: DHEA treatment
    DHEA : 200 mg/day hard gelatine capsule
  • Drug: Placebo
    Treatment : 200 mg/day hard gelatine capsule
Study Arms  ICMJE
  • Experimental: 1
    DHEA
    Intervention: Drug: DHEA treatment
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 26, 2007)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2015
Estimated Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 ≥ 25 mmHg (**) related to normal pulmonary capillary pressure assessed by catheterization of the right side of the heart (pulmonary capillary wedge pressure ≤12mmHg)
  • PO2 ≤ 60 mmHg assessed by arterial gazometry at ease (**) or PO2 > 60 mmHg, but related with high hypoxemia after exercise (six-minute walk test )
  • Oxygenotherapy more than 6 months before pre-screening
  • Written informed consent

(*) Inclusion of young adults concerns COPD related to asthma or cystic fibrosis (**) Criteria assessed from last health check or the last exams for COPD diagnosis

Exclusion Criteria:

  • clinical instability and/or respiratory exacerbation within the previous three months
  • 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 prédnisolone 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) (> 2,5ng/ml)
  • Cancer antecedent or treatment on going
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00581087
Other Study ID Numbers  ICMJE Dromer
AFSSAPS 040479
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Bordeaux
Study Sponsor  ICMJE University Hospital, Bordeaux
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Claire Dromer, Dr University Hospital, Bordeaux
Study Chair: Nicholas Moore, Pr Universty Hospital, Bordeaux
Study Director: Eric Dumas De La Roque, Dr University Hospital, Bordeaux
PRS Account University Hospital, Bordeaux
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP