Evidence map›Paper›PMID 36089068›Full record

Trial reportChest2023

Assessing Daily Life Physical Activity by Actigraphy in Pulmonary Arterial Hypertension: Insights From the Randomized Controlled Study With Selexipag (TRACE).

Luke S Howard, Stephan Rosenkranz, Robert P Frantz, Anna R Hemnes, Thomas Pfister, Shu-Fang Hsu Schmitz, Hall Skåra, Marc Humbert, Ioana R Preston

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase IV
In one paragraph

Trial report in Chest, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03078907 (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), which is not on this map. Cited by 24 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 3 pooled it
4.0field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03078907 phase4completednot on this map

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

TypeinterventionalSponsorActelionRan2017 to 2020Enrolled108ConditionsPulmonary Arterial HypertensionArmsSelexipag, Placebo
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 3 syntheses or guidelines pooled it, 31 citations in OpenAlex.

  1. Pooled it
  2. Management of pulmonary arterial hypertension in systemic sclerosis: from classical treatments to new horizons.European respiratory review : an official journal of the European Respiratory Society · 2026
    Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Remote exercise assessment in pulmonary hypertension.Current opinion in pulmonary medicine · 2026
    Review
  7. Review
  8. Article
  9. Article
  10. Review
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Review
  17. Exploring the patient perspective in pulmonary hypertension.The European respiratory journal · 2024
    Article
  18. Treatment algorithm for pulmonary arterial hypertension.The European respiratory journal · 2024
    Review
  19. Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 7 institutions in 5 countries.

Luke S HowardHammersmith Hospital, Imperial College Healthcare NHS Trust, London, England. Electronic address: l.howard@imperial.ac.uk.
Stephan RosenkranzHeart Centera, University Hospital Cologne, and Cologne Cardiovascular Research Center (CCRC), Cologne, Germany.
Robert P FrantzMayo Clinic, Rochester, MN, USA.
Anna R HemnesVanderbilt University Medical Center, Nashville, TN, USA.
Thomas PfisterActelion Pharmaceuticals Ltd, Allschwil, Switzerland.
Shu-Fang Hsu SchmitzActelion Pharmaceuticals Ltd, Allschwil, Switzerland.
Hall SkåraEuropean Pulmonary Hypertension Association (PHA Europe), Vienna, Austria.
Marc HumbertUniversité Paris-Saclay, Faculty of Medicine, Le Kremlin-Bicêtre, France; Department of Respiratory and Intensive Care Medicine, Assistance Publique-Hôpitaux de Paris, Hôpital Bicêtre, Le Kremlin-Bicêtre, France; INSERM UMR_S 999, Hôpital Marie Lannelongue, Le Plessis-Robinson, France.
Ioana R PrestonTufts Medical Center, Boston, MA, USA.
Actelion (Switzerland) · CHAssistance Publique – Hôpitaux de Paris · FRHammersmith Hospital · GBMayo Clinic in Arizona · USTufts Medical Center · USUniversity Hospital Cologne · DEVanderbilt University Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundReduced daily life physical activity (DLPA) in pulmonary arterial hypertension (PAH) contributes to a poor quality of life. RESEARCH QUESTION: Can actigraphy be used to assess changes in DLPA in patients with PAH receiving selexipag or placebo? STUDY DESIGN AND

methodsEffect of Selexipag on Daily Life Physical Activity of Patients With Pulmonary Arterial Hypertension (TRACE) was a prospective, multicenter, randomized, placebo-controlled, double-blind, exploratory phase 4 study enrolling patients with PAH in World Health Organization functional class II/III, receiving stable endothelin receptor antagonist with/without phosphodiesterase type 5 inhibitor background therapy. Primary end points were change from baseline to Week 24 in actigraphy-assessed DLPA (recorded by using an accelerometer), including daily time spent in nonsedentary physical activity (NSPA), daily time spent in moderate to vigorous physical activity (MVPA), daily volume of activity, and daily number of steps.

resultsAt baseline, patients (N = 108) were prevalent, on stable background PAH therapy, and at low risk of disease progression. Patients showed high compliance with wear of the accelerometer throughout the study. From baseline to Week 24, mean daily time spent in NSPA increased by 1.1 min and decreased by 16.7 min in the selexipag and placebo groups (treatment difference [95% CI], 17.8 [-6.0, 41.6] min); mean time spent in MVPA increased by 0.3 min and was reduced by 2.0 min in the selexipag and placebo groups (treatment difference [95% CI], 2.3 [-10.8, 15.4] min); and mean number of daily steps decreased by 0.3 and 201.9 in the selexipag and placebo groups (treatment difference [95% CI], 201.6 [-243.0, 646.2]).

interpretationTRACE enrolled a prevalent population on background therapy and at low risk of disease progression. Changes in DLPA were small and highly variable, with no statistically significant differences between treatment groups. This patient-centric study was the first randomized trial in PAH to capture high-quality actigraphy data and to describe DLPA in terms of mean/median and variability, which may inform the design of future studies. CLINICAL

trial registrationClinicalTrials.gov; No.: NCT03078907; URL: www. CLINICALTRIALS: gov.

Indexed as

Hypertension, PulmonaryPulmonary Arterial HypertensionAcetamidesActigraphyAntihypertensive AgentsDisease ProgressionExerciseFamilial Primary Pulmonary HypertensionHumansProspective StudiesPyrazinesQuality of LifeAcetamidesAntihypertensive AgentsPyrazinesselexipagactigraphydaily life physical activitypulmonary arterial hypertensionquality of lifeselexipag

Identifiers

PMID36089068
PMCPMC9899640
OpenAlexW4294957982

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.