Pulmonary HypertensionNCT05610631
Pulmonary Hypertension Registry Switzerland
An observational study of Pulmonary Hypertension, run by University of Zurich at 1 site in Switzerland.
Trial summary
Registry Data from PH-patients in Switzerland, who have given consent to records for research purposes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Hypertension
- How many people
- 1,000 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2017to Dec 2027
- How long will I take part?
- 10 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pulmonary Hypertension (PH)
Who may be able to join
- Patients with PH
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Respiratory Clinic, University Hospital of Zurich
Zurich, 8091
Silvia Ulrich, Prof. Dr., ++41442554362, silvia.ulrich@usz.ch
Konrad Bloch, Prof. Dr., ++41442551111, konrad.bloch@usz.ch
About this study
Official title: Swiss PH Registry - Cohort of Swiss PH Patients
Registry Data from PH-patients in Switzerland, who have given consent to records for research purposes.
- Conditions
- Pulmonary Hypertension
- Medical subject headings
- Hypertension, Pulmonary
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 |
|---|---|---|
| Pulmonary arterial hypertension | Pulmonary arterial hypertension | |
| PH due to left heart diseases | PH due to left heart diseases | |
| PH due to lung disease and/or hypoxia | PH due to lung disease and/or hypoxia | |
| Chronic thromboembolic PH | Chronic thromboembolic PH | |
| Miscellaneous PH | Miscellaneous PH |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walking distance
6-minute walking distance
Measured: within the study duration e.g. up to 10 years
Secondary outcomes (4)
New York Heart Association functional class
New York Heart Association functional class
Measured: within the study duration e.g. up to 10 years
NTproBNP
NTproBNP
Measured: within the study duration e.g. up to 10 years
Survival
time to death analysis
Measured: within the study duration e.g. up to 10 years
Medication
escalation of clinical therapy
Measured: within the study duration e.g. up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start1 Jun 2017
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- 1,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Actelion
- Responsible party
- Sponsor
- Investigators
- Silvia Ulrich, Prof. Dr., Principal investigator, UniversityHospital Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05610631
- Sponsor's protocol ID
- Swiss PH Registry
- Status last verified
- Nov 2022
- First submitted
- 1 Nov 2022
- Last updated
- 9 Nov 2022
- 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 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Swiss PH Registry - Cohort of Swiss PH Patients
- ClinicalTrials.gov ID
- NCT05610631
- Acronym / sponsor ID
- Swiss PH Registry
- Conditions
- Pulmonary Hypertension
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Actelion
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 9 Nov 2022 (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.
Registry Data from PH-patients in Switzerland, who have given consent to records for research purposes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Pulmonary arterial hypertension | – | –Pulmonary arterial hypertension |
| PH due to left heart diseases | – | –PH due to left heart diseases |
| PH due to lung disease and/or hypoxia | – | –PH due to lung disease and/or hypoxia |
| Chronic thromboembolic PH | – | –Chronic thromboembolic PH |
| Miscellaneous PH | – | –Miscellaneous PH |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pulmonary Hypertension (PH)
Key inclusion criteria (1 listed)
- Patients with PH
Key exclusion criteria (1 listed)
- -
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
6-minute walking distance
Time frame: within the study duration e.g. up to 10 years
6-minute walking distance
4 secondary outcomes
New York Heart Association functional class
Time frame: within the study duration e.g. up to 10 years
NTproBNP
Time frame: within the study duration e.g. up to 10 years
Survival
Time frame: within the study duration e.g. up to 10 years
Medication
Time frame: within the study duration e.g. up to 10 years
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 9 Nov 2022.
- 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.
Silvia Ulrich, Prof. Dr. principal investigator
UniversityHospital Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension, run by University of Zurich at 1 site in Switzerland.
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 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: looking for participants now, as of the sponsor's last update on 9 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
Contact Silvia Ulrich, Prof. Dr. (+41442552220, silvia.ulrich@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-minute walking distance (time frame: within the study duration e.g. up to 10 years). 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 9 Nov 2022.