Back to resultsEffect of Selexipag on Daily Life Physical Activity of Patients With Pulmonary Arterial Hypertension. (TRACE)
Primary Purpose
Pulmonary Arterial Hypertension
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Selexipag
Placebo
Sponsored by
About this trial
This is an interventional other trial for Pulmonary Arterial Hypertension focused on measuring daily life, physical activity, actigraphy, PAH-SYMPACT
Eligibility Criteria
Inclusion Criteria:
- Male or female between 18 and 75 years old inclusive.
- Women of childbearing potential must have a negative serum pregnancy test at planned visits and use an acceptable method of birth control from screening up to 30 days after study treatment discontinuation.
Symptomatic pulmonary arterial hypertension (PAH) belonging to one of the following subgroups only:
- Idiopathic
- Heritable
- Drug or toxin induced
- Associated with one of the following: connective tissue disease; HIV infection; corrected simple congenital heart disease.
With the following hemodynamic characteristics assessed by right heart catheterization (RHC) prior to randomization:
- Mean pulmonary artery pressure (mPAP) ≥ 25 mmHg
- Pulmonary vascular resistance (PVR) ≥ 240 dyn•sec/cm5 (or 3 Wood Units)
- Pulmonary artery wedge pressure (PCWP) or left ventricular end-diastolic pressure (LVEDP) ≤ 15 mmHg.
- Treatment with an endothelin receptor antagonist (ERA) for at least 90 days and on a stable dose for 30 days prior to randomization.
- If an ERA is given in combination with a phosphodiesterase-5 (PDE-5) inhibitor or soluble guanylate cyclase (sGC) stimulator, these treatments must be ongoing for at least 90 days and on a stable dose for 30 days prior to randomization.
- WHO functional class (FC) II or III at randomization
- 6-minute walk distance (6MWD) ≥ 100 m at screening.
- Ability to walk without a walking aid.
- Valid baseline data for daily life physical activity (DLPA) and PAH-SYMPACT®.
Exclusion Criteria:
- Patients on a PAH-specific monotherapy targeting the nitric oxide pathway (i.e. PDE-5 inhibitor or sGC stimulator).
- Patients treated with prostacyclin, prostacyclin analog or selexipag within 3 months prior to screening.
- Any hospitalization during the last 30 days prior to screening.
- Severe coronary heart disease or unstable angina.
- Documented severe hepatic impairment or severe renal insufficiency at screening.
- Participation in a cardio-pulmonary rehabilitation program based on exercise training within 8 weeks prior to screening
- Any factor or condition likely to affect full participation in the study or compliance with the protocol (such as adherence to protocol mandated procedures), as judged by the investigator.
Sites / Locations
- LA Biomedical Research Institute
- Northside Hospital
- Kentuckiana Pulmonary Research Center
- Tufts Medical Center, Pulmonary/Critical Care & Sleep
- University of Nebraska Medical Center, Pulmonary, Critical Care & Sleep Medicine Division
- NYU Winthrop Hospital
- UNC Pulmonary Speciality Clinic
- Duke University School of Medicine, Duke Pulmonary Vascular Disease center
- University of Cincinnati, Heart, Lung and Vascular Institute
- CCF- Akron General Medical Hospital
- Integris Baptist Medical Center
- University of Pennsylvania, Pulmonary Vascular Disease Program
- Vanderbilt University Medical Center, Care Medicine
- Methodist Clinical Trials
- University of Texas Health Science Center (San Antonio)
- Medizinische Universität Innsbruck (MUI), Abt. für Pneumologie, Haus 2
- Krankenhaus der Elisabethinen, Servicestelle Klinische Studien
- Hôpital Bicêtre, ervice de Pneumologie et Réanimation respiratoire
- CHRU de Lille - Hôpital Albert Calmette, Service de cardiologie
- Hospital Larrey CHU de Toulouse
- Universitätsklinikum Giessen
- Herzzentrum der Universität zu Köln, Klinik III für Innere Medizin
- Universitätsklinikum Leipzig AöR, Abteilung Pneumologie
- Katholisches Klinikum Lünen/Werne GmbH, Haus E
- Mater Misericordiae University Hospital
- Oslo University Hospital, dept of cardiology
- Centro Hospitalar e Universitário de Coimbra, Serviço de Cardiologia
- Hospital Geral de Santo António-DEFI
- Sahlgrenska University Hospital, Gothenburg
- Skåne University Hospital, VO Hjärt och Lungmedicin
- Kantonsspital St. Gallen, Klinik für Pneumologie und Schlafmedizin
- Universitaetsspital Zurich, Klinik für Pneumologie C HOER 11
- Papworth Hospital, Pulmonary Vascular Disease Unit
- Golden Jubilee National Hospital, Scottish Pulmonary Vascular Unit
- The Royal Free Hospital, Cardiology Department
- Royal Brompton Hospital, Hypertension
- Hammersmith Hospital
- Freeman Hospital, Cardiothoracic Department
- Royal Hallamshire Hospital, Pulmonary Vascular Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Selexipag
Placebo
Arm Description
Selexipag is up-titrated from Day 1 to Week 12 to the individualized highest tolerated dose (HTD), which can range from 200 mcg b.i.d. to 1600 mcg b.i.d., in 200 mcg steps starting with 200 mcg b.i.d. Then, the dose is increased in increments of 200 mcg b.i.d., usually at weekly intervals, depending on the dose tolerability. Up-titration is followed by a stable maintenance treatment period at the highest tolerated dose, from Week 13 to Week 24.
Regimen and titration scheme similar to those in the selexipag group
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
Change From Baseline to Week 24 in Total Sleep Time (TST)
TST (in minutes) was assessed by actigraphy.
Change From Baseline to Week 24 in Wake After Sleep Onset (WASO)
WASO (in minutes) was assessed by actigraphy.
Change From Baseline to Week 24 in Number of Awakenings
Number of awakenings was assessed by actigraphy.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03078907
Brief Title
Effect of Selexipag on Daily Life Physical Activity of Patients With Pulmonary Arterial Hypertension.
Acronym
TRACE
Official Title
A Multi-center, Double-blind, Placebo-controlled Phase 4 Study in Patients With Pulmonary Arterial Hypertension to Assess the Effect of Selexipag on Daily Life Physical Activity and Patient's Self-reported Symptoms and Their Impacts
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
November 8, 2017 (Actual)
Primary Completion Date
February 10, 2020 (Actual)
Study Completion Date
February 10, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Actelion
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
This study is designed as exploratory with the purpose to generate hypotheses on new endpoints
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension
Keywords
daily life, physical activity, actigraphy, PAH-SYMPACT
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Selexipag
Arm Type
Experimental
Arm Description
Selexipag is up-titrated from Day 1 to Week 12 to the individualized highest tolerated dose (HTD), which can range from 200 mcg b.i.d. to 1600 mcg b.i.d., in 200 mcg steps starting with 200 mcg b.i.d. Then, the dose is increased in increments of 200 mcg b.i.d., usually at weekly intervals, depending on the dose tolerability. Up-titration is followed by a stable maintenance treatment period at the highest tolerated dose, from Week 13 to Week 24.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Regimen and titration scheme similar to those in the selexipag group
Intervention Type
Drug
Intervention Name(s)
Selexipag
Other Intervention Name(s)
ACT-293987, Uptravi
Intervention Description
Film-coated tablets for oral use; one tablet (200 mcg) to eight tablets (1600 mcg) are administered depending on the individual tolerability.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching film coated tablets
Primary Outcome Measure Information:
Title
Change From Baseline to Week 24 in Actigraphy Assessed Daily Life Physical Activity (DLPA) for Variables Expressed in Minutes
Description
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)
Title
Change From Baseline to Week 24 in Actigraphy DLPA for Variables Expressed in Percentage (%)
Description
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)
Title
Change From Baseline to Week 24 in Actigraphy DLPA for Variables Expressed in Counts Per Minute (Counts/Minute)
Description
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.
Time Frame
Baseline and Week 24 (data analysis was done during 14-Days each for Baseline and for Week 24 and mean value reported)
Title
Change From Baseline to Week 24 in Actigraphy DLPA for Variables Expressed in Counts
Description
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)
Title
Change From Baseline to Week 24 in Actigraphy DLPA for Variable Expressed in Step Counts
Description
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)
Title
Change From Baseline to Week 24 in Actigraphy DLPA for Variables Expressed in Step Counts/Minute
Description
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)
Title
Change From Baseline to Week 24 in Total Sleep Time (TST)
Description
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)
Title
Change From Baseline to Week 24 in Wake After Sleep Onset (WASO)
Description
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)
Title
Change From Baseline to Week 24 in Number of Awakenings
Description
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)
Title
Change From Baseline to Week 24 in Sleep Efficiency (SE)
Description
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)
Secondary Outcome Measure Information:
Title
Change From Baseline to Week 24 in Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT) Score
Description
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
Title
Number of Participants With Change From Baseline to Week 24 in World Health Organization Functional Class (WHO FC)
Description
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
Title
Change From Baseline to Week 24 in 6-Minute Walk Distance (6MWD)
Description
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
Title
Change From Baseline to Week 24 in Borg Dyspnea Score
Description
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
Title
Change From Baseline to Week 24 in N-Terminal Pro B-type Natriuretic Peptide (NT-proBNP)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female between 18 and 75 years old inclusive.
Women of childbearing potential must have a negative serum pregnancy test at planned visits and use an acceptable method of birth control from screening up to 30 days after study treatment discontinuation.
Symptomatic pulmonary arterial hypertension (PAH) belonging to one of the following subgroups only:
Idiopathic
Heritable
Drug or toxin induced
Associated with one of the following: connective tissue disease; HIV infection; corrected simple congenital heart disease.
With the following hemodynamic characteristics assessed by right heart catheterization (RHC) prior to randomization:
Mean pulmonary artery pressure (mPAP) ≥ 25 mmHg
Pulmonary vascular resistance (PVR) ≥ 240 dyn•sec/cm5 (or 3 Wood Units)
Pulmonary artery wedge pressure (PCWP) or left ventricular end-diastolic pressure (LVEDP) ≤ 15 mmHg.
Treatment with an endothelin receptor antagonist (ERA) for at least 90 days and on a stable dose for 30 days prior to randomization.
If an ERA is given in combination with a phosphodiesterase-5 (PDE-5) inhibitor or soluble guanylate cyclase (sGC) stimulator, these treatments must be ongoing for at least 90 days and on a stable dose for 30 days prior to randomization.
WHO functional class (FC) II or III at randomization
6-minute walk distance (6MWD) ≥ 100 m at screening.
Ability to walk without a walking aid.
Valid baseline data for daily life physical activity (DLPA) and PAH-SYMPACT®.
Exclusion Criteria:
Patients on a PAH-specific monotherapy targeting the nitric oxide pathway (i.e. PDE-5 inhibitor or sGC stimulator).
Patients treated with prostacyclin, prostacyclin analog or selexipag within 3 months prior to screening.
Any hospitalization during the last 30 days prior to screening.
Severe coronary heart disease or unstable angina.
Documented severe hepatic impairment or severe renal insufficiency at screening.
Participation in a cardio-pulmonary rehabilitation program based on exercise training within 8 weeks prior to screening
Any factor or condition likely to affect full participation in the study or compliance with the protocol (such as adherence to protocol mandated procedures), as judged by the investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Pfister
Organizational Affiliation
Actelion
Official's Role
Study Director
Facility Information:
Facility Name
LA Biomedical Research Institute
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Northside Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Kentuckiana Pulmonary Research Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Tufts Medical Center, Pulmonary/Critical Care & Sleep
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
University of Nebraska Medical Center, Pulmonary, Critical Care & Sleep Medicine Division
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
NYU Winthrop Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
UNC Pulmonary Speciality Clinic
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Duke University School of Medicine, Duke Pulmonary Vascular Disease center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
University of Cincinnati, Heart, Lung and Vascular Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0564
Country
United States
Facility Name
CCF- Akron General Medical Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44307
Country
United States
Facility Name
Integris Baptist Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
University of Pennsylvania, Pulmonary Vascular Disease Program
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Vanderbilt University Medical Center, Care Medicine
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-2650
Country
United States
Facility Name
Methodist Clinical Trials
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Texas Health Science Center (San Antonio)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Medizinische Universität Innsbruck (MUI), Abt. für Pneumologie, Haus 2
City
Innsbruck
ZIP/Postal Code
06020
Country
Austria
Facility Name
Krankenhaus der Elisabethinen, Servicestelle Klinische Studien
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Hôpital Bicêtre, ervice de Pneumologie et Réanimation respiratoire
City
Le Kremlin-Bicêtre
ZIP/Postal Code
94270
Country
France
Facility Name
CHRU de Lille - Hôpital Albert Calmette, Service de cardiologie
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Hospital Larrey CHU de Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Universitätsklinikum Giessen
City
Giessen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Herzzentrum der Universität zu Köln, Klinik III für Innere Medizin
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Universitätsklinikum Leipzig AöR, Abteilung Pneumologie
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Katholisches Klinikum Lünen/Werne GmbH, Haus E
City
Lünen
ZIP/Postal Code
44534
Country
Germany
Facility Name
Mater Misericordiae University Hospital
City
Dublin
ZIP/Postal Code
D07 R2WY
Country
Ireland
Facility Name
Oslo University Hospital, dept of cardiology
City
Oslo
ZIP/Postal Code
0372
Country
Norway
Facility Name
Centro Hospitalar e Universitário de Coimbra, Serviço de Cardiologia
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Hospital Geral de Santo António-DEFI
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Sahlgrenska University Hospital, Gothenburg
City
Gothenburg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Skåne University Hospital, VO Hjärt och Lungmedicin
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Kantonsspital St. Gallen, Klinik für Pneumologie und Schlafmedizin
City
St. Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
Universitaetsspital Zurich, Klinik für Pneumologie C HOER 11
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Papworth Hospital, Pulmonary Vascular Disease Unit
City
Cambridge
ZIP/Postal Code
Cb23 3RE
Country
United Kingdom
Facility Name
Golden Jubilee National Hospital, Scottish Pulmonary Vascular Unit
City
Clydebank
ZIP/Postal Code
G81 4DY
Country
United Kingdom
Facility Name
The Royal Free Hospital, Cardiology Department
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Royal Brompton Hospital, Hypertension
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom
Facility Name
Hammersmith Hospital
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Facility Name
Freeman Hospital, Cardiothoracic Department
City
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Royal Hallamshire Hospital, Pulmonary Vascular Medicine
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
36089068
Citation
Howard LS, Rosenkranz S, Frantz RP, Hemnes AR, Pfister T, Hsu Schmitz SF, Skara H, Humbert M, Preston IR. Assessing Daily Life Physical Activity by Actigraphy in Pulmonary Arterial Hypertension: Insights From the Randomized Controlled Study With Selexipag (TRACE). Chest. 2023 Feb;163(2):407-418. doi: 10.1016/j.chest.2022.08.2231. Epub 2022 Sep 8.
Results Reference
derived
Learn more about this trial
Effect of Selexipag on Daily Life Physical Activity of Patients With Pulmonary Arterial Hypertension.
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