Pulmonary Arterial HypertensionTripleTRE-NISNCT06445673
A Prospective Non-interventional Observational Study to Observe Long-term Treatment and Outcomes in Pulmonary Arterial Hypertension (PAH) Patients
An observational study of Pulmonary Arterial Hypertension, run by AOP Orphan Pharmaceuticals AG at 18 sites in 9 countries.
Trial summary
The goal of this observational study is to learn about the long-term development and outcomes of different treatment patterns of patients who initially participated in the TripleTRE study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension
- How many people
- 110 participants
- Where
- 18 sitesin 9 countries
- Study dates
- 31 Jul 2024to Jun 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The study population will consist of patients who participated in the TripleTRE study and who have not been lost to follow-up and have given a written informed consent for their participation in the NIS.
Who may be able to join
- 1. Patients previously participating in the randomized TripleTRE trial who are able and willing to provide a signed informed consent for study participation in NIS
Who cannot join
- Lost to follow-up patients of TripleTRE study
- Patients who discontinued all medicinal PAH treatments (e.g. after successful lung transplantation)
- Patients who withdrew from the initial TripleTRE trial due to significant non-compliance with trial requirements (not adhering to therapy, not coming to hospital visits)
Trial locations and contacts
18 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
18 sites in 9 countries
Germany3 sites
DRK Kliniken Berlin Westend
Berlin
University Hospital Carl Gustav Carus of Technical University Dresden
Dresden
Universitätsmedizin Greifswald
Greifswald
Czechia2 sites
Fakultní Nemocnice Olomouc
Olomouc
Všeobecná fakultní nemocnice v Praze
Prague
France2 sites
Hôpital Bicêtre-- Assistance Publique Hopitaux de Paris
Paris
Hôpitaux Universitaires de Strasbourg
Strasbourg
Hungary2 sites
Gottsegen National Cardiovascular lnstitute
Budapest
Medical University of Szeged
Szeged
Poland2 sites
John Paul II Hospital Krakow
Krakow
Fryderyk Chopin Hospital in European Health Centre Otwock
Otwock
Romania2 sites
Emergency Institute for Cardiovascular Diseases Prof. Dr. C.C.Iliescu
Bucharest
Emergency Clinical County Hospital of Targu Mures
Târgu Mureş
Spain2 sites
Hospital Clinic of Barcelona
Barcelona
Hospital Ramon y Cajal
Madrid
About this study
Official title: A Prospective, Multicenter, International Non-interventional, Observational Cohort Study to Observe Long-term Treatment Patterns and Real-word Outcomes in PAH Group I Patients Previously Participating in TripleTRE - TripleTRE-NIS
The goal of this observational study is to learn about the long-term development and outcomes of different treatment patterns of patients who initially participated in the TripleTRE study.
The primary objective of this non-interventional follow-up study is to assess the long-term real-world clinical outcomes, including disease progression and survival rates, in patients who initially participated in and completed the randomized TripleTRE trial.
Planned observation duration per patient is a minimum of 3 years.
- Conditions
- Pulmonary Arterial Hypertension
- 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.
| Study group | Role | What they receive |
|---|---|---|
| TripleTRE NIS patients | all patients previously treated within the TripleTRE trial who are willing to participate in this NIS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to death or lung transplantation
Measured: up to year 3
Time to first clinical worsening
clinical worsening is defined as fulfilling on of the following criteria:
- PAH related death (including all deaths where PAH cannot be excluded as cause)
- Lung transplantation due to PAH
- PAH-related hospitalization
- Post baseline decrease in 6MWD by 15%
- Post baseline worsening of WHO FC
Measured: up to year 3
Total number of clinical worsenings
clinical worsening is defined as fulfilling on of the following criteria:
- PAH related death (including all deaths where PAH cannot be excluded as cause)
- Lung transplantation due to PAH
- PH-related hospitalization
- Post baseline decrease in 6MWD by 15%
- Post baseline worsening of WHO FC
Measured: up to year 3
Secondary outcomes (21)
Long-term change in 6MWD
6-Minute Walking Distance (6MWD) will be measured in meters
Measured: up to year 3
Long-term change in PAH treatment regimens
any change or addition of new PH medication including dosing in time
Measured: up to year 3
Long-term change in risk status
Risk status measured by simplified four-strata risk-assessment tool
Measured: up to year 3
Long-term change in WHO FC
World Health Organization Functional Class (WHO FC) is categorized from I (no symptoms) to IV (severe dyspnea and symptoms)
Measured: up to year 3
Long-term change in BDS
BDS - Borg Dyspnea Score, ranging from 0 (no exertion) to 10 (maximum)
Measured: up to year 3
Long-term change in NT-proBNP/BNP
NT-proBNP/BNP: N-terminal pro Brain Natriuretic Peptide
Measured: up to year 3
Long-term change in Pulmonary Vascular Resistance (PVR)
PVR to be measured in WU Parameter will be collected according to clinical routine
Measured: up to year 3
Long-term change in mean Pulmonary Arterial Pressure (mPAP)
mPAP to be measured in mmHg Parameter will be collected according to clinical routine
Measured: up to year 3
Long-term change in Right Atrial Pressure (RAP)
RAP to be measured in mmHg Parameter will be collected according to clinical routine
Measured: up to year 3
Long-term change in mean Right Atrial Pressure (mRAP)
mean Right Atrial Pressure (mRAP) to be measured in mmHg Parameter will be collected according to clinical routine
Measured: up to year 3
Long-term change in Cardiac Index (CI)
Cardiac index (CI) measured in liters per minute per square meter Parameter will be collected according to clinical routine
Measured: up to year 3
Long-term change in Cardiac Output (CO)
Cardiac output (CO) measured in liters per minute Parameter will be collected according to clinical routine
Measured: up to year 3
Long-term change in Pulmonary capillary wedge pressure (PCWP)
Pulmonary capillary wedge pressure (PCWP) measured in mmHg Parameter will be collected according to clinical routine
Measured: up to year 3
Long-term change in Stroke volume index (SVI)
Parameter will be collected according to clinical routine
Measured: up to year 3
Long-term change in RV-PA coupling
RV-PA coupling estimated by the ratio of tricuspid annular plane systolic excursion by pulmonary artery systolic pressure Parameter will be collected according to clinical routine
Measured: up to year 3
Long-term change in RV end-diastolic area (RVEDA)
RV end-diastolic area (RVEDA) measured in square centimeters Parameter will be collected according to clinical routine
Measured: up to year 3
Long-term change in RV end-systolic area (RVESA)
RV end-systolic area (RVESA) measured in square centimeters Parameter will be collected according to clinical routine
Measured: up to year 3
Long-term change in RV fractional area change (RVFAC)
RV fractional area change (RVFAC) calculated in % Parameter will be collected according to clinical routine
Measured: up to year 3
Long-term change in Right Atrium (RA) area
Right Atrium (RA) area in square centimeters Parameter will be collected according to clinical routine
Measured: up to year 3
Long-term change in Pericardial effusion
Pericardial effusion assessment will be done and rated as yes/no Parameter will be collected according to clinical routine
Measured: up to year 3
Long-term change in Right ventricular ejection fraction (RVEF)
Parameter will be collected according to clinical routine
Measured: up to year 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start31 Jul 2024
- Primary completionJun 2030 (estimated)
- Study completionJun 2030 (estimated)
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
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AOP Orphan Pharmaceuticals AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06445673
- Sponsor's protocol ID
- TREV1-10P.NIS
- Acronym
- TripleTRE-NIS
- Status last verified
- Oct 2026
- First submitted
- 29 May 2024
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, International Non-interventional, Observational Cohort Study to Observe Long-term Treatment Patterns and Real-word Outcomes in PAH Group I Patients Previously Participating in TripleTRE - TripleTRE-NIS
- ClinicalTrials.gov ID
- NCT06445673
- Acronym / sponsor ID
- TripleTRE-NIS / TREV1-10P.NIS
- Conditions
- Pulmonary Arterial Hypertension
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- AOP Orphan Pharmaceuticals AGIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 6 Jun 2024 (actual)
- 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 goal of this observational study is to learn about the long-term development and outcomes of different treatment patterns of patients who initially participated in the TripleTRE study.
The primary objective of this non-interventional follow-up study is to assess the long-term real-world clinical outcomes, including disease progression and survival rates, in patients who initially participated in and completed the randomized TripleTRE trial.
Planned observation duration per patient is a minimum of 3 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TripleTRE NIS patients | – | –all patients previously treated within the TripleTRE trial who are willing to participate in this NIS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of patients who participated in the TripleTRE study and who have not been lost to follow-up and have given a written informed consent for their participation in the NIS.
Key inclusion criteria (1 listed)
- 1. Patients previously participating in the randomized TripleTRE trial who are able and willing to provide a signed informed consent for study participation in NIS
Key exclusion criteria (3 listed)
- Lost to follow-up patients of TripleTRE study
- Patients who discontinued all medicinal PAH treatments (e.g. after successful lung transplantation)
- Patients who withdrew from the initial TripleTRE trial due to significant non-compliance with trial requirements (not adhering to therapy, not coming to hospital visits)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to death or lung transplantation
Time frame: up to year 3
Time to first clinical worsening
Time frame: up to year 3
clinical worsening is defined as fulfilling on of the following criteria: * PAH related death (including all deaths where PAH cannot be excluded as cause) * Lung transplantation due to PAH * PAH-related hospitalization * Post baseline decrease in 6MWD by 15% * Post baseline worsening of WHO FC
Total number of clinical worsenings
Time frame: up to year 3
clinical worsening is defined as fulfilling on of the following criteria: * PAH related death (including all deaths where PAH cannot be excluded as cause) * Lung transplantation due to PAH * PH-related hospitalization * Post baseline decrease in 6MWD by 15% * Post baseline worsening of WHO FC
21 secondary outcomes
Long-term change in 6MWD
Time frame: up to year 3
Long-term change in PAH treatment regimens
Time frame: up to year 3
Long-term change in risk status
Time frame: up to year 3
Long-term change in WHO FC
Time frame: up to year 3
Long-term change in BDS
Time frame: up to year 3
Long-term change in NT-proBNP/BNP
Time frame: up to year 3
Long-term change in Pulmonary Vascular Resistance (PVR)
Time frame: up to year 3
Long-term change in mean Pulmonary Arterial Pressure (mPAP)
Time frame: up to year 3
Long-term change in Right Atrial Pressure (RAP)
Time frame: up to year 3
Long-term change in mean Right Atrial Pressure (mRAP)
Time frame: up to year 3
Long-term change in Cardiac Index (CI)
Time frame: up to year 3
Long-term change in Cardiac Output (CO)
Time frame: up to year 3
Long-term change in Pulmonary capillary wedge pressure (PCWP)
Time frame: up to year 3
Long-term change in Stroke volume index (SVI)
Time frame: up to year 3
Long-term change in RV-PA coupling
Time frame: up to year 3
Long-term change in RV end-diastolic area (RVEDA)
Time frame: up to year 3
Long-term change in RV end-systolic area (RVESA)
Time frame: up to year 3
Long-term change in RV fractional area change (RVFAC)
Time frame: up to year 3
Long-term change in Right Atrium (RA) area
Time frame: up to year 3
Long-term change in Pericardial effusion
Time frame: up to year 3
Long-term change in Right ventricular ejection fraction (RVEF)
Time frame: up to year 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Arterial Hypertension, run by AOP Orphan Pharmaceuticals AG at 18 sites in 9 countries.
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 1 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Germany, Austria, Czechia, France, Hungary and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
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?
Time to death or lung transplantation (time frame: up to year 3). The study lists 3 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 29 Oct 2026.