Pulmonary Arterial HypertensionLONGACTNCT02309463
Correlation of LONGterm Wrist ACTigraphy Recorded Physical Performance & 6-minute Walk Distance in Patients With Pulmonary Arterial Hypertension
An observational study of Pulmonary Arterial Hypertension, run by Actelion.
Trial summary
The objective of the study is to monitor physical activity longitudinally with a wrist activity tracker specifically in PAH patients newly initiating ERA therapy and to assess the correlation with the 6MWD at different time points. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Endothelin receptor antagonist therapy
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 31 Jan 2015to 28 Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with PAH, and not receiving ERA therapy in the 30 days prior to the enrolment visit, are eligible for inclusion in this study. Patients in need of ERA therapy will receive ERA treatment according to the physician's decision
Who may be able to join
- Male or female patients with right heart catheter (RHC)-confirmed PAH (WHO PH group I)
- Age ≥18 year
- Not receiving ERA therapy in the 30 days prior to the enrolment visit
- Signed patient informed consent form
Who cannot join
- Patient with conditions that prevent compliance with the protocol or to adhere to therapy and use of the device
About this study
Official title: A Prospective Multicenter Study to Assess the Correlation of LONGterm Wrist ACTigraphy Recorded Physical Performance and 6-minute Walk Distance in Patients With Pulmonary Arterial Hypertension Newly Initiating Endothelin Receptor Antagonist Therapy
The objective of the study is to monitor physical activity longitudinally with a wrist activity tracker specifically in PAH patients newly initiating ERA therapy and to assess the correlation with the 6MWD at different time points. Further objectives are to assess the correlation of physical activity measured with the tracker and other parameters for clinical evaluation and right ventricular function assessment (i.e. Biomarkers, WHO Functional class, hospitalization due to PAH, Echochardiography and Quality of Life) as well as sleep efficacy in PAH patients newly initiating ERA therapy.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Endothelin receptor antagonist therapy
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endothelin receptor antagonist therapyDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity score measured with an electronic activity tracker and absolute 6MWD assessed at different time points during ERA treatment
Measured: Baseline to Week 54
Change of physical activity measured with an electronic activity tracker and 6MWD in PAH patients newly initiating ERA therapy between visit 0 and end of observation
Measured: baseline to week 54
Secondary outcomes (5)
WHO Functional Class
Measured: Baseline to Week 54
NT-ProBNP/BNP
Measured: Baseline to Week 54
Echocardiography parameters
- Tricuspid pressure gradient
- TAPSE
- Pulmonary outflow tract acceleration time
- Right ventricular fractional area change
- Pericardial effusion
Measured: Baseline to Week 54
Number of hospitalization due to PAH (min. overnight)
Measured: Baseline to Week 54
Quality of Life
Minnesota Living with Heart Failure Questionnaire (MLHFQ)
Measured: Baseline to Week 54
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2014 (estimated)
- Study start31 Jan 2015
- Primary completion31 Jan 2016 (estimated)
- Study completion28 Feb 2017 (estimated)
Why it stopped: EC did not accept measurement of patient's activity for the primary end-point with a non-validated activity tracking device
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actelion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02309463
- Sponsor's protocol ID
- AC-055-506
- Acronym
- LONGACT
- Status last verified
- Jun 2025
- First submitted
- 22 Oct 2014
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Study to Assess the Correlation of LONGterm Wrist ACTigraphy Recorded Physical Performance and 6-minute Walk Distance in Patients With Pulmonary Arterial Hypertension Newly Initiating Endothelin Receptor Antagonist Therapy
- ClinicalTrials.gov ID
- NCT02309463
- Acronym / sponsor ID
- LONGACT / AC-055-506
- Conditions
- Pulmonary Arterial Hypertension
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: EC did not accept measurement of patient's activity for the primary end-point with a non-validated activity tracking device
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ActelionIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2015 (actual)
- Primary completion
- 31 Jan 2016 (estimated)
- Study completion
- 28 Feb 2017 (estimated)
- First posted
- 5 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to monitor physical activity longitudinally with a wrist activity tracker specifically in PAH patients newly initiating ERA therapy and to assess the correlation with the 6MWD at different time points. Further objectives are to assess the correlation of physical activity measured with the tracker and other parameters for clinical evaluation and right ventricular function assessment (i.e. Biomarkers, WHO Functional class, hospitalization due to PAH, Echochardiography and Quality of Life) as well as sleep efficacy in PAH patients newly initiating ERA therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with PAH, and not receiving ERA therapy in the 30 days prior to the enrolment visit, are eligible for inclusion in this study. Patients in need of ERA therapy will receive ERA treatment according to the physician's decision
Key inclusion criteria (4 listed)
- Male or female patients with right heart catheter (RHC)-confirmed PAH (WHO PH group I)
- Age ≥18 year
- Not receiving ERA therapy in the 30 days prior to the enrolment visit
- Signed patient informed consent form
Key exclusion criteria (1 listed)
- Patient with conditions that prevent compliance with the protocol or to adhere to therapy and use of the device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endothelin receptor antagonist therapy | Drug | – |
Primary outcome
Activity score measured with an electronic activity tracker and absolute 6MWD assessed at different time points during ERA treatment
Time frame: Baseline to Week 54
Change of physical activity measured with an electronic activity tracker and 6MWD in PAH patients newly initiating ERA therapy between visit 0 and end of observation
Time frame: baseline to week 54
5 secondary outcomes
WHO Functional Class
Time frame: Baseline to Week 54
NT-ProBNP/BNP
Time frame: Baseline to Week 54
Echocardiography parameters
Time frame: Baseline to Week 54
Number of hospitalization due to PAH (min. overnight)
Time frame: Baseline to Week 54
Quality of Life
Time frame: Baseline to Week 54
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Arterial Hypertension, run by Actelion.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activity score measured with an electronic activity tracker and absolute 6MWD assessed at different time points during ERA treatment (time frame: Baseline to Week 54). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2025.