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Completed

NCT Number: NCT03078907

Effect of Selexipag on Daily Life Physical Activity of Patients With Pulmonary Arterial Hypertension.

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.

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Key information

Conditions

Pulmonary Arterial Hypertension Behavior Hypertension, Pulmonary Lung Diseases Motor Activity Respiratory Tract Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medizinische Universität Innsbruck (MUI), Abt. für Pneumologie, Haus 2, Innsbruck, Austria

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About this study

This study is designed as exploratory with the purpose to generate hypotheses on new endpoints

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Selexipag

Drug

Film-coated tablets for oral use; one tablet (200 mcg) to eight tablets (1600 mcg) are administered depending on the individual tolerability.

Other names: ACT-293987, Uptravi

Placebo

Drug

Matching film coated tablets

Primary outcomes

  1. Change From Baseline to Week 24 in Actigraphy Assessed Daily Life Physical Activity (DLPA) for Variables Expressed in Minutes

    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 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.

  2. Change From Baseline to Week 24 in Actigraphy DLPA for Variables Expressed in Percentage (%)

    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 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.

  3. Change From Baseline to Week 24 in Actigraphy DLPA for Variables Expressed in Counts Per Minute (Counts/Minute)

    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 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.

  4. Change From Baseline to Week 24 in Actigraphy DLPA for Variables Expressed in Counts

    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 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.

  5. Change From Baseline to Week 24 in Actigraphy DLPA for Variable Expressed in Step Counts

    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 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.

  6. Change From Baseline to Week 24 in Actigraphy DLPA for Variables Expressed in Step Counts/Minute

    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 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.

  7. Change From Baseline to Week 24 in Total Sleep Time (TST)

    Time frame: Baseline and Week 24 (data analysis was done during 14-Days each for Baseline and for Week 24 and mean value reported)

    TST (in minutes) was assessed by actigraphy.

  8. Change From Baseline to Week 24 in Wake After Sleep Onset (WASO)

    Time frame: Baseline and Week 24 (data collection was done during 14-Days each for Baseline and for Week 24)

    WASO (in minutes) was assessed by actigraphy.

  9. Change From Baseline to Week 24 in Number of Awakenings

    Time frame: Baseline and Week 24 (data collection was done during 14-Days each for Baseline and for Week 24)

    Number of awakenings was assessed by actigraphy.

  10. Change From Baseline to Week 24 in Sleep Efficiency (SE)

    Time frame: Baseline and Week 24 (data collection was done during 14-Days each for Baseline and for Week 24)

    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 outcomes

  1. Change From Baseline to Week 24 in Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT) Score

    Time frame: Baseline and Week 24

    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.

  2. Number of Participants With Change From Baseline to Week 24 in World Health Organization Functional Class (WHO FC)

    Time frame: Baseline and Week 24

    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.

  3. Change From Baseline to Week 24 in 6-Minute Walk Distance (6MWD)

    Time frame: Baseline and Week 24

    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.

  4. Change From Baseline to Week 24 in Borg Dyspnea Score

    Time frame: Baseline and Week 24

    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.

  5. Change From Baseline to Week 24 in N-Terminal Pro B-type Natriuretic Peptide (NT-proBNP)

    Time frame: Baseline and Week 24

    Change from baseline to Week 24 in NT-pro BNP levels was reported. The negative change from baseline means improvement.

Sponsors and collaborators

Lead sponsor

Actelion

Industry

Registry information

Official study 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

Acronym: TRACE

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Mar 14, 2017
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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