The primary objective of this study is to evaluate the effect of selexipag on the physical activity of patients with pulmonary arterial hypertension (PAH) in their daily life, by using a wearable wrist device (actigraph). The actigraph will collect data on daily life physical activity in the patient's real environment. In addition, the PAH symptoms and their impacts will be assessed by using an electronic patient reported outcome measure in the patient's real environment. Patients will be assigned randomly to either selexipag or placebo.
This study is designed as exploratory with the purpose to generate hypotheses on new endpoints
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
108
Change From Baseline to Week 24 in Actigraphy Assessed Daily Life Physical Activity (DLPA) for Variables Expressed in Minutes
Change from baseline to Week 24 of the DLPA activity parameters for daily time spent in non-sedentary activity (NSA) (as defined by Freedson '98 and Koster '16) and daily time spent in moderate-to-vigorous physical activity (MVPA) as defined by Freedson '98 were reported. These variables were assessed by actigraphy and were expressed in minutes. Freedson 1998 established ranges of activity counts obtained from a hip worn accelerometer corresponding to commonly employed MET categories. Based on this work, threshold between sedentary and NSA was defined. This threshold is often referred to as Freedson's 1998 publication. Koster 2016 defined the threshold between sedentary and NSA based on wrist-worn accelerometers on non-dominant hand, respectively. Positive change from baseline means improvement.
Time frame: Baseline and Week 24 (data analysis was done during 14-Days each for Baseline and for Week 24 and mean value reported)
Change From Baseline to Week 24 in Actigraphy DLPA for Variables Expressed in Percentage (%)
Change from baseline to Week 24 of the DLPA activity parameters for daily time spent in non-sedentary activity (NSA) (Freedson '98), daily time spent in moderate-to-vigorous physical activity (MVPA) (Freedson '98) and dailytime spent in NSA (Koster '16) were reported. These variables were assessed by actigraphy and were expressed in percentage (%). Freedson 1998 established ranges of activity counts obtained from a hip worn accelerometer corresponding to commonly employed MET categories. Based on this work, threshold between sedentary and NSA was defined. This threshold is often referred to as Freedson's 1998 publication. Koster 2016 defined the threshold between sedentary and NSA based on wrist-worn accelerometers on non-dominant hand, respectively. Positive change from baseline means improvement.
Time frame: Baseline and Week 24 (data analysis was done during 14-Days each for Baseline and for Week 24 and mean value reported)
Change From Baseline to Week 24 in Actigraphy DLPA for Variables Expressed in Counts Per Minute (Counts/Minute)
Change from baseline to Week 24 of the DLPA activity parameter for total daily activities and NSA (Koster '16) were reported. These variables were assessed by actigraphy and were expressed in counts/minutes. Koster 2016 defined the threshold between sedentary and NSA based on wrist-worn accelerometers on non-dominant hand, respectively. Positive change from baseline means improvement.
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LA Biomedical Research Institute
Torrance, California, United States
Northside Hospital
Atlanta, Georgia, United States
Kentuckiana Pulmonary Research Center
Louisville, Kentucky, United States
Tufts Medical Center, Pulmonary/Critical Care & Sleep
Boston, Massachusetts, United States
University of Nebraska Medical Center, Pulmonary, Critical Care & Sleep Medicine Division
Omaha, Nebraska, United States
NYU Winthrop Hospital
Mineola, New York, United States
UNC Pulmonary Speciality Clinic
Chapel Hill, North Carolina, United States
Duke University School of Medicine, Duke Pulmonary Vascular Disease center
Durham, North Carolina, United States
University of Cincinnati, Heart, Lung and Vascular Institute
Cincinnati, Ohio, United States
CCF- Akron General Medical Hospital
Cleveland, Ohio, United States
...and 29 more locations
Time frame: Baseline and Week 24 (data analysis was done during 14-Days each for Baseline and for Week 24 and mean value reported)
Change From Baseline to Week 24 in Actigraphy DLPA for Variables Expressed in Counts
Change from baseline to Week 24 of the DLPA activity parameters for volume of non-sedentary activity (Koster '16)were reported. These variables were assessed by actigraphy and were expressed in counts. Koster 2016 defined the threshold between sedentary and NSA based on wrist-worn accelerometers on non-dominant hand, respectively. Positive change from baseline means improvement.
Time frame: Baseline and Week 24 (data analysis was done during 14-Days each for Baseline and for Week 24 and mean value reported)
Change From Baseline to Week 24 in Actigraphy DLPA for Variable Expressed in Step Counts
Change from baseline to Week 24 of the DLPA activity parameters for number of steps during awake time were reported. These variables were assessed by actigraphy and were expressed in step counts. Positive change from baseline means improvement.
Time frame: Baseline and Week 24 (data analysis was done during 14-Days each for Baseline and for Week 24 and mean value reported)
Change From Baseline to Week 24 in Actigraphy DLPA for Variables Expressed in Step Counts/Minute
Change from baseline to Week 24 of the DLPA activity parameters for number of steps during awake time were reported. These variables were assessed by actigraphy and were expressed in step counts/minute. Positive change from baseline means improvement.
Time frame: Baseline and Week 24 (data analysis was done during 14-Days each for Baseline and for Week 24 and mean value reported)
Change From Baseline to Week 24 in Total Sleep Time (TST)
TST (in minutes) was assessed by actigraphy.
Time frame: Baseline and Week 24 (data analysis was done during 14-Days each for Baseline and for Week 24 and mean value reported)
Change From Baseline to Week 24 in Wake After Sleep Onset (WASO)
WASO (in minutes) was assessed by actigraphy.
Time frame: Baseline and Week 24 (data collection was done during 14-Days each for Baseline and for Week 24)
Change From Baseline to Week 24 in Number of Awakenings
Number of awakenings was assessed by actigraphy.
Time frame: Baseline and Week 24 (data collection was done during 14-Days each for Baseline and for Week 24)
Change From Baseline to Week 24 in Sleep Efficiency (SE)
SE (in percentage) was assessed by actigraphy. Sleep efficiency was defined as the TST divided by the time in bed (minutes) multiplied by 100. TST was the duration in minutes including REM sleep plus NREM sleep during the time spent in bed.
Time frame: Baseline and Week 24 (data collection was done during 14-Days each for Baseline and for Week 24)
Change From Baseline to Week 24 in Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT) Score
PAH-SYMPACT has 2 main parts: symptoms (cardiopulmonary and cardiovascular) and impact (physical impacts and cognitive/emotional). The symptom part is a questionnaire completed daily for 7 consecutive days and contains 11 items. The impact part has a 7-day recall period and is completed on 7th day of symptoms questionnaire data collection period. It contains 11 items pertaining to impact of PAH. The average Cardiopulmonary Symptoms and cardiovascular symptoms domain scores are determined based on daily scores of 6 and 5 items, respectively, reported on a 5-point Likert scale with score range from 0=best to 4=worst. The Physical impacts and Cognitive/emotional domain consists of 7 items reported on a 5-point Likert scale (from 0 to 4). The value 0 = "not at all"/"with no difficulty at all" and value 4 = "very much"/"extremely"/ "not able at all". Mean value on each of 7-day period was calculated for each specific domain score and corresponding mean change from baseline was reported.
Time frame: Baseline and Week 24
Number of Participants With Change From Baseline to Week 24 in World Health Organization Functional Class (WHO FC)
The WHO FC of pulmonary hypertension is a physical activity rating scale as follows: Class I (No limitation of physical activity); Class II (Slight limitation of physical activity); Class III (Marked limitation of physical activity); and Class IV (Inability to carry out any physical activity without symptoms). The change from baseline in WHO FC was classified into "Improved", "No change" and "Worsened" compared to baseline. Deterioration, No Change, and Improvement are based on shift of risk category (I, II, III, IV) from baseline in WHO Functional Class.
Time frame: Baseline and Week 24
Change From Baseline to Week 24 in 6-Minute Walk Distance (6MWD)
The 6MWD was the total distance walked during 6 minutes. Mean change from baseline (distance walked at Week 24 minus distance walked at baseline) was reported.
Time frame: Baseline and Week 24
Change From Baseline to Week 24 in Borg Dyspnea Score
The Borg dyspneas score was a self-rating scale to evaluate the severity of dyspnea (from 0 "no shortness of breath at all" to 10 "very, very severe / maximal") shortness of breath. It was completed immediately after the 6-minute walk test at Week 24 and at baseline. Mean change from baseline in scoring was reported.
Time frame: Baseline and Week 24
Change From Baseline to Week 24 in N-Terminal Pro B-type Natriuretic Peptide (NT-proBNP)
Change from baseline to Week 24 in NT-pro BNP levels was reported. The negative change from baseline means improvement.
Time frame: Baseline and Week 24