BICYCLE trial.

• Conditions: Pulmonary arterial hypertensionExercise inducedCongenital heart diseaseAdvanced treatmentCardiopulmonary exercise testPulmonale arteriële hypertensieInspanningsgebondenCongenitale hartziektenCardiopulmonale inspanningstest

• Registration Number: NL-OMON20429
• Lead Sponsor: Academic Medical Center - University of Amsterdam

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

1. Adult (>18 years) and mentally competent;

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:

1. Incapable of giving informed consent;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of this study is to determine change in mean pulmonary arterial pressure at peak exercise in adult congenital heart disease patients with exercise-induced pulmonary arterial hypertension before and after treatment with bosentan, compared to patients treated with placebo.

Secondary Outcome Measures

Name	Time	Method
To determine:<br /><br>1. Cardiopulmonary exercise capacity: i.e. peak oxygen consumption, VE/VCO2 ratio, O2 pulse;<br /><br>2. Pulmonary hemodynamics: i.e. systolic pulmonary arterial pressure, pulmonary vascular resistance, pressure-flow relationships during and at peak exercise;<br /><br>3. Right ventricular function: i.e. TAPSE, TEI index, TDI-S, right ventricular dimensions;<br /><br>4. Laboratory parameters:<br />i.e. NT-pro BNP, troponin T;<br /><br>5. NYHA functional class;<br /><br>6. Quality of life: assessed by TAAQOL-CHD, SF-36 and Minnesota CHD-HF questionnaire.