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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alexander Van De Bruaene, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01218607
First received: October 8, 2010
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Heart Septal Defects, Atrial
Drug: Bosentan
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Pulmonary vascular resistance [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    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:
  • Peak oxygen consumption [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    The highest oxygen uptake available by bicycle ergometry despite further work rate increases and effort by the subject.

  • Right ventricular function [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Right ventricular function as assessed by echocardiography.

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


Enrollment: 10
Study Start Date: October 2010
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01218607

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

No publications provided

Responsible Party: Alexander Van De Bruaene, Dr, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01218607     History of Changes
Other Study ID Numbers: UZL-S52480
Study First Received: October 8, 2010
Last Updated: March 4, 2014
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

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

Additional relevant MeSH terms:
Heart Septal Defects
Heart Septal Defects, Atrial
Vascular Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Bosentan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014