Study on the effect of the drug selexipag in adult patients with elevated pressure in the pulmonary arteries due to a cardiac birth defect

Prostacyclin receptor agonist Selexipag in patients with pulmonary arterial hypertension and congenital heart disease - SELECT trial

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003495-53-NL

Enrollment

Unknown

Registered

2016-12-15

Start date

2016-11-29

Completion date

Unknown

Last updated

2017-01-09

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

Conditions

Pulmonary arterial hypertension related to congenital heart disease.

Interventions

Trade Name: Selexipag Product Name: Selexipag Pharmaceutical Form: Film-coated tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Male and female patients = 18 years old - Symptomatic PAH related to congenital heart disease of all complexities - WHO functional class II-III - Documented hemodynamic diagnosis of PAH by right heart catheterization or echocardiography, performed at time prior to screening - Patients not receiving treatment for PAH or those who are receiving endothelin-receptor antagonist, a phosphodiesterase type 5 inhibitor or both at a dose that has been stable for 3 months - Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 85 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: - WHO functional class IV - Patients who have received prostacyclin (analogs) treatment within 1 month before baseline visit or are scheduled to receive any of these drugs during the trial - Patients with moderate or severe hepatic impairment (Child-Pugh B and C) - Females who are lactating or pregnant or plan to become pregnant during the study (a pregnancy test is offered to every female patient within the fertile age) - Known hypersensitivity to any of the excipients of the drug formulations - Contraindication for trial medication - Contraindication for cardiopulmonary exercise test - Incapable of giving informed consent

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine whether the use of selexipag on top of current PAH medication improves exercise capacity in adult patients with pulmonary arterial hypertension related to congenital heart disease;Secondary Objective: 1. Time-to-first-(PAH-related) morbidity event or death 2. Onset of (supra)ventricular arrhythmias 3. Worsening of WHO functional class 4. Increase right ventricular function parameters with echocardiography 5. Decrease in serum biomarkers (NT-pro-BNP) 6. Increase in Quality-of-Life scores 7. Number of adverse and serious adverse events ;Primary end point(s): percentage change in exercise capacity;Timepoint(s) of evaluation of this end point: At 6 months of treatment with selexipag and at 12 months of study	—

Measure

Time frame

Main Objective: To determine whether the use of selexipag on top of current PAH medication improves exercise capacity in adult patients with pulmonary arterial hypertension related to congenital heart disease;Secondary Objective: 1. Time-to-first-(PAH-related) morbidity event or death 2. Onset of (supra)ventricular arrhythmias 3. Worsening of WHO functional class 4. Increase right ventricular function parameters with echocardiography 5. Decrease in serum biomarkers (NT-pro-BNP) 6. Increase in Quality-of-Life scores 7. Number of adverse and serious adverse events ;Primary end point(s): percentage change in exercise capacity;Timepoint(s) of evaluation of this end point: At 6 months of treatment with selexipag and at 12 months of study

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Secondary

Measure	Time frame
Secondary end point(s): 1. Time-to-first-(PAH-related) morbidity event or death 2. Onset of (supra)ventricular arrhythmias 3. Worsening of WHO functional class 4. Increase right ventricular function parameters with echocardiography 5. Decrease in serum biomarkers (NT-pro-BNP) 6. Increase in Quality-of-Life scores 7. Number of adverse events and serious adverse events ;Timepoint(s) of evaluation of this end point: At 6 months of treatment with selexipag and at 12 months of study	—

Measure

Time frame

Secondary end point(s): 1. Time-to-first-(PAH-related) morbidity event or death 2. Onset of (supra)ventricular arrhythmias 3. Worsening of WHO functional class 4. Increase right ventricular function parameters with echocardiography 5. Decrease in serum biomarkers (NT-pro-BNP) 6. Increase in Quality-of-Life scores 7. Number of adverse events and serious adverse events ;Timepoint(s) of evaluation of this end point: At 6 months of treatment with selexipag and at 12 months of study

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Countries

Netherlands

Contacts

Public ContactBarbara Mulder

Academic Medical Center

b.j.m.mulder@amc.uva.nl+310205665988

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026