Bosentan in Exercise Induced Pulmonary Arterial Hypertension in Congenital Heart Disease

Bosentan in Exercise Induced Pulmonary Arterial Hypertension in Congenital Heart Disease - BICYCLE trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40031

Enrollment

Registered

2013-03-20

Start date

2013-06-14

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exercise induced pulmonary arterial hypertension increased pulmonary pressure during exercise

Interventions

After randomization one group (n=20) receives a 125 mg tablet of Bosentan twice daily for 6 months. The other group (n=20) receives placebo for 6 months.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - adult (>18 years) and mentally competent - Open or closed septal defect (ASD I/II, VSD, AVSD) - Open or closed systemic-to-pulmonary shunt (PDA) - Negative pregnancy test - Presence of X-PAH, including one of the following criteria, at peak exercise. * mPAP > 34 mmHg with CO 40 mmHg with CO 45 mmHg with CO 50 mmHg with CO 2.5 mmHg/l/min during exercise

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Incapable of giving informed consent - Pregnancy or lactation (a pregnancy test is offered to every female patient within fertile age) - Women of child-bearing age who are sexually active without practising reliable methods of contraception. The use of oral contraceptives only, is not considered reliable. - Substance abuse (alcohol, medicines, drugs) - Subjects who are not able to perform cardiopulmonary exercise testing - Any cardiac operation three times upper normal limit - Arterial hypotension (systolic blood pressure

Design outcomes

Primary

Measure	Time frame
To determine: • change in mean pulmonary arterial pressure (mPAP) at peak exercise o measured by means of transthoracic echocardiography at 3 and 6 months followup: mPAP = 0.6 x systolic PAP. o peak exercise is defined as 80% of maximum calculated heart rate: peak exercise=0.8*(220-age)	—

Secondary

Measure	Time frame
To determine: • Cardiopulmonary exercise capacity (i.e. peak oxygen consumption, VE/VCO2 ratio, O2 pulse) • Pulmonary hemodynamics (i.e. systolic pulmonary arterial pressure, pulmonary vascular resistance, pressure-flow relationships during and at peak exercise) • Right ventricular function (i.e. TAPSE, TEI index, TDI-S, right ventricular dimensions) • Laboratory parameters (i.e. NT-pro BNP, troponin T) • NYHA functional class • Quality of life (assessed by TAAQOL-CHD, SF-36 and Minnesota CHD-HF questionnaire) • Demographics (age, gender, marital status, work, income); assessed by demographic questionnaire.	—

Measure

Time frame

To determine: • Cardiopulmonary exercise capacity (i.e. peak oxygen consumption, VE/VCO2 ratio, O2 pulse) • Pulmonary hemodynamics (i.e. systolic pulmonary arterial pressure, pulmonary vascular resistance, pressure-flow relationships during and at peak exercise) • Right ventricular function (i.e. TAPSE, TEI index, TDI-S, right ventricular dimensions) • Laboratory parameters (i.e. NT-pro BNP, troponin T) • NYHA functional class • Quality of life (assessed by TAAQOL-CHD, SF-36 and Minnesota CHD-HF questionnaire) • Demographics (age, gender, marital status, work, income); assessed by demographic questionnaire.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)