Bosentan for Mild Pulmonary Vascular Disease in Asd Patients. (BOMPA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01218607
Recruitment Status : Completed
First Posted : October 11, 2010
Last Update Posted : March 5, 2014
Information provided by (Responsible Party):
Alexander Van De Bruaene, Universitaire Ziekenhuizen Leuven

Brief Summary:

Volume overload due to left-to-right shunting in patients with atrial septal defect type secundum causes pulmonary vascular disease over a long period of time. Pulmonary vascular resistance can be assessed non-invasively using bicycle stress echocardiography. By measuring cardiac output and pulmonary artery pressures at different stages of exercise, a pressure-output plot can be obtained. The slope of the pressure-output plot reflects pulmonary vascular resistance. In patients undergoing ASD repair after the age of 40 years, pulmonary vascular resistance was higher when compared to age-matched controls, indicating the presence of mild pulmonary vascular disease. Bosentan has been shown to decrease pulmonary vascular resistance.

The investigators hypothesize that in patients with an ASD type secundum, who underwent ASD repair after the age of 40 years, administration of bosentan decreases pulmonary vascular resistance as assessed by bicycle stress echocardiography.

Condition or disease Intervention/treatment Phase
Heart Septal Defects, Atrial Drug: Bosentan Drug: Placebo Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: BOsentan for Mild Pulmonary Vascular Disease in Asd Patients (the BOMPA Trial): a Double-blind, Randomized Controlled, Pilot Trial
Study Start Date : October 2010
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Bosentan

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Placebo will be taken twice daily for 16 weeks

Active Comparator: Active Drug: Bosentan
Treatment will be initiated at a dose of 62.5 mg twice daily for 4 weeks and then increased to the maintenance dose of 125 mg twice daily for 12 weeks.
Other Name: Bosentan = Tracleer

Primary Outcome Measures :
  1. Pulmonary vascular resistance [ Time Frame: 16 weeks ]
    Pulmonary vascular resistance can be measured using bicycle stress echocardiography by estimating the slope of a pressure-flow plot using linear regression analysis.

Secondary Outcome Measures :
  1. Peak oxygen consumption [ Time Frame: 16 weeks ]
    The highest oxygen uptake available by bicycle ergometry despite further work rate increases and effort by the subject.

  2. Right ventricular function [ Time Frame: 16 weeks ]
    Right ventricular function as assessed by echocardiography.

  3. Liver function abnormalities [ Time Frame: 4, 8,12 and16 weeks ]
    An increase in ASAT and/or ALAT equal or more than 3 times the upper limit of normal.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Signed informed consent by patient prior to initiation of any study-mandated procedure.
  • Male or female patients > 40 years with atrial septal defect type secundum and > 40 years of age at the time of repair
  • Women of childbearing potential must have a negative pre-treatment pregnancy test and must use a reliable method of contraception during study treatment and for at least 3 months after study treatment termination.
  • Women not of childbearing potential are defined as postmenopausal (amenorrhea for at least 1 year), or documented surgically or naturally sterile.

Exclusion Criteria:

  • Pregnancy or lactation
  • Women of child-bearing age who are sexually active without practising reliable methods of contraception
  • Any disease or impairment that, in the opinion of the investigator, excludes a subject from participation
  • Substance abuse (alcohol, medicines, drugs)
  • Other medical, psychological or social circumstances that would adversely affect a patient's ability to participate adequately in the study or increase the risk to the patient or others in the case of participation
  • Insufficient compliance
  • Subjects who are not able to perform cardiopulmonary exercise testing
  • ASD repair < 6 months before inclusion
  • PAH of any aetiology other than the one specified in the inclusion criteria
  • Impairment of organic function (renal, hepatic)
  • Arterial hypotension (systolic blood pressure < 85 mmHg)
  • Anaemia (Hb< 10 g/dl)
  • Decompensated symptomatic polycythemia
  • Thrombocytopenia (< 50000/µl)
  • Significant valvular diseases, other than tricuspid or pulmonary regurgitation
  • Chronic lung disease or total lung capacity < 80% of predicted value
  • History of significant pulmonary embolism
  • Other relevant diseases (HIV infection, Hep B/C infection)
  • Subjects with known intolerance to bosentan or their constituents
  • Prohibited medication: any medication listed below which has not been discontinued at least 30 days prior to screening

    • Unspecified or other significant medication (glyburide or immunosuppression)
    • Drugs to treat PAH (endothelin receptor antagonists, PDE-5 antagonists, prostanoids)
    • Medication that is not compatible with bosentan or that interferes with its metabolism (inhibitors of CYP2C9 or CYP3A4) or that, in the investigator's opinion, may interfere with bosentan treatment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01218607

University Hospitals Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Principal Investigator: Werner Budts, MD, PhD University Hospitals Leuven

Responsible Party: Alexander Van De Bruaene, Dr, Universitaire Ziekenhuizen Leuven Identifier: NCT01218607     History of Changes
Other Study ID Numbers: UZL-S52480
First Posted: October 11, 2010    Key Record Dates
Last Update Posted: March 5, 2014
Last Verified: March 2014

Keywords provided by Alexander Van De Bruaene, Universitaire Ziekenhuizen Leuven:
Heart Septal Defects, Atrial
Pulmonary Circulation
Ventricular Function, Right
Echocardiography, Stress
Tissue Doppler Imaging

Additional relevant MeSH terms:
Vascular Diseases
Heart Septal Defects
Heart Septal Defects, Atrial
Cardiovascular Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Heart Diseases
Congenital Abnormalities
Antihypertensive Agents
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action