Clinical trial NCT04435782: A Study of Selexipag Assessing Right Ventricular Remodeling in Pulmonary Arterial Hypertension by Cardiac Magnetic Resonance Imaging
Official title: A Prospective, Multicenter, Single-Arm, Open-Label, Phase 4 Study of the Effects of Selexipag on Right Ventricular Remodeling in Pulmonary Arterial Hypertension Assessed by Cardiac Magnetic Resonance Imaging
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pulmonary Arterial Hypertension
Keywords: Right ventricle
Reverse remodeling
Magnetic resonance Imaging
Lead sponsor: Actelion
Sponsor class: INDUSTRY
First posted: 2020-06-17
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess the effects of selexipag on right ventricular (RV) function in participants with Pulmonary arterial hypertension (PAH).


Eligibility criteria: Inclusion Criteria:

* World health organization functional class (WHO FC) II or III. Enrollment will be stratified by WHO FC II or III. Proportion of participants with WHO FC II and WHO FC III are expected to be approximately 40 percent (%) and 60%, respectively
* Pulmonary arterial hypertension (PAH) etiology belonging to one of the following groups according to 6th world symposium of pulmonary hypertension (WSPH) classification: a) Idiopathic PAH, b) Heritable PAH, c) Drugs or toxins induced d) PAH associated with connective tissue disease, e) PAH associated with congenital heart disease, with simple systemic-to-pulmonary shunt at least 1 year after surgical repair
* Patients already receiving PAH-specific oral mono or dual therapy (that is, phosphodiesterase type 5 inhibitors \[PDE-5i\] or soluble guanylate cyclase stimulators \[sGCs\] and/or endothelin receptor antagonist \[ERA\]) or patients who are not candidates for these therapies
* N-terminal-pro-hormone brain natriuretic peptide (NT-proBNP) greater than or equal to (\>=) 300 nanograms per liter (ng/L) (greater than or equal to \[\>=\] 300 picograms per milliliter \[pg/mL\]; \>=35.5 picomoles per liter \[pmol/L\]) at screening
* Women of childbearing potential must meet the following criteria: a) Have a negative serum pregnancy test during screening and a negative urine pregnancy test on Day 1, b) Agree to use acceptable methods of contraception from Day 1 to at least 30 days after study intervention discontinuation, c) If only using hormonal contraception, have used it for at least 1 month (30 days) before Day 1, and d) Agree to perform monthly pregnancy tests to at least 30 days after study intervention discontinuation
* 6-minute walking distance (6MWD) \>=150 meter (m) during screening period

Exclusion Criteria:

* Prior use of Prostacyclin (IP)-receptor agonist, prostacyclin, or prostacyclin analog. Use of such treatments for vasoreactivity testing is not exclusionary; intermittent use of such treatments for digital ulcers or Raynaud's phenomenon is not exclusionary if stopped \> 6 months (180 days) prior to Day 1
* Treatment with strong inhibitors of CYP2C8 (example, gemfibrozil) within 4 weeks (28 days) prior to Day 1
* Treatment with another investigational drug planned or taken within 12 weeks (84 days) prior to Day 1
* Severe coronary heart disease or unstable angina
* Cerebrovascular events (example, transient ischemic attack, stroke) within 3 months (90 days) prior to Day 1

Primary outcomes:
measure: Change From Baseline to Week 26 in Right Ventricular Stroke Volume (RVSV) Assessed by Pulmonary Artery Flow Magnetic Resonance Imaging (MRI)
timeFrame: Baseline, Week 26
Secondary outcomes:
measure: Change From Baseline to Week 26 in Right Ventricular End-Diastolic Volume (RVEDV) Assessed by MRI
timeFrame: Baseline, Week 26
measure: Change From Baseline to Week 26 in Right Ventricular End-Systolic Volume (RVESV) Assessed by MRI
timeFrame: Baseline, Week 26
measure: Change From Baseline to Week 26 in Right Ventricular Ejection Fraction (RVEF) Assessed by MRI
timeFrame: Baseline, Week 26
measure: Change From Baseline to Week 26 in Right Ventricular (RV) Mass Index Assessed by MRI
timeFrame: Baseline, Week 26
measure: Change From Baseline to Week 26 in Right Ventricular Global Longitudinal Strain (RVGLS) Assessed by MRI
timeFrame: Baseline, Week 26
measure: Number of Participants With Change From Baseline to Week 26 in World Health Organization (WHO) Functional Class
timeFrame: Baseline, Week 26
measure: Change From Baseline to Week 26 in N-terminal-Pro-Hormone Brain Natriuretic Peptide (NT-proBNP)
timeFrame: Baseline, Week 26
measure: Change From Baseline to Week 26 in 6-Minute Walk Distance (6MWD)
timeFrame: Baseline, Week 26
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days)
measure: Number of Participants With Adverse Events (AEs) Leading to Premature Discontinuation of Study Drug
timeFrame: Day 1 up to last dose of study drug (up to Week 52)
measure: Number of Participants With Adverse Events of Special Interest (AESI)
timeFrame: Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days)
measure: Number of Participants With Treatment-Emergent Marked Laboratory Abnormalities
timeFrame: Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days)
measure: Change From Baseline to Week 26 in Number of Non-invasive Low-risk Criteria Among the 8 Variables
timeFrame: Baseline, Week 26
measure: Change From Baseline to Week 26 in Number of Non-invasive Low-risk Criteria Among the 3 Variables
timeFrame: Baseline, Week 26
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University Of California San Diego
state: California
city: Anderson
country: United States
facility: AnMed Health
state: South Carolina
city: Dallas
country: United States
facility: UT Southwestern
state: Texas
city: Caba
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Caba
country: Argentina
facility: Sanatorio Ramon Cereijo
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Instituto Cardiovascular de Buenos Aires
city: Porto Alegre
country: Brazil
facility: Associacao Hospitalar Moinhos de Vento
city: Porto Alegre
country: Brazil
facility: Irmandade Santa Casa de Misericordia de Porto Alegre
city: Sao Paulo
country: Brazil
facility: SPDM - Associacao Paulista para o Desenvolvimento da Medicina - Hospital Sao Paulo
city: Sao Paulo
country: Brazil
facility: Hospital Das Clinicas Da Faculdade De Medicina Da USP
city: La Tronche
country: France
facility: CHU Grenoble
city: Berlin
country: Germany
facility: DRK Kliniken Westend
city: Bonn
country: Germany
facility: Universitatsklinikum Bonn
city: Mainz
country: Germany
facility: Universitatsmedizin der Johannes Gutenberg Universitat Mainz
city: Hong Kong
country: Hong Kong
facility: Grantham Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital University of Hong Kong
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Petah Tikva
country: Israel
facility: Rabin Medical Center Beilinson Campus
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Kuala Lumpur
country: Malaysia
facility: Institut Jantung Negara
city: Amsterdam
country: Netherlands
facility: VUMC Amsterdam
city: Nijmegen
country: Netherlands
facility: Radboud Umcn
city: Moscow
country: Russian Federation
facility: National Medical Research Center of Cardiology of MoH of Russian Federation
city: St Petersburg
country: Russian Federation
facility: Federal State Budgetary Institution
city: Riyadh
country: Saudi Arabia
facility: King Faisal Specialist Hospital & Research Center
city: Singapore
country: Singapore
facility: National Heart Centre (NHC) Singapore
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
city: Abu Dhabi
country: United Arab Emirates
facility: Cleveland Clinic Abu Dhabi
city: Glasgow
country: United Kingdom
facility: Golden Jubilee National Hospital
city: Hampstead
country: United Kingdom
facility: Royal Free Hospital
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital
Study officials:
affiliation: Actelion
name: Actelion Clinical Trial
role: STUDY_DIRECTOR
References: