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

• Register: EUCTR
• Last refreshed on: 9 January 2017
• Main ID: EUCTR2016-003495-53-NL
• Date of registration: 15/12/2016
• Prospective Registration: No
• Primary sponsor: Academic Medical Center - Cardiology
• Public title: Study on the effect of the drug selexipag in adult patients with elevated pressure in the pulmonary arteries due to a cardiac birth defect
• Scientific title: Prostacyclin receptor agonist Selexipag in patients with pulmonary arterial hypertension and congenital heart disease - SELECT trial
• Date of first enrolment: 29/11/2016
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-003495-53
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Netherlands

Contacts

• Name: Barbara Mulder
• Affiliation: Academic Medical Center

• Name: Barbara Mulder
• Affiliation: Academic Medical Center

Key inclusion & exclusion 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:
- 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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Pulmonary arterial hypertension related to congenital heart disease.

Intervention(s)

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

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: At 6 months of treatment with selexipag and at 12 months of study

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

Secondary Outcome(s)

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

Secondary ID(s)

NL59009.018.16

Source(s) of Monetary Support

Netherlands Heart Institute