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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01218607
Other study ID # UZL-S52480
Secondary ID
Status Completed
Phase Phase 3
First received October 8, 2010
Last updated March 4, 2014
Start date October 2010
Est. completion date March 2014

Study information

Verified date March 2014
Source Universitaire Ziekenhuizen Leuven
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicines and Health Products, FAMHP
Study type Interventional

Clinical Trial 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.


Description:

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Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

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.
Placebo
Placebo will be taken twice daily for 16 weeks

Locations

Country Name City State
Belgium University Hospitals Leuven Leuven Vlaams-Brabant

Sponsors (1)

Lead Sponsor Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pulmonary vascular resistance Pulmonary vascular resistance can be measured using bicycle stress echocardiography by estimating the slope of a pressure-flow plot using linear regression analysis. 16 weeks No
Secondary Peak oxygen consumption The highest oxygen uptake available by bicycle ergometry despite further work rate increases and effort by the subject. 16 weeks No
Secondary Right ventricular function Right ventricular function as assessed by echocardiography. 16 weeks No
Secondary Liver function abnormalities An increase in ASAT and/or ALAT equal or more than 3 times the upper limit of normal. 4, 8,12 and16 weeks Yes
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