Pulmonary HypertensionNCT04145024
Giessen Pulmonary Hypertension Registry and Biobank
An observational study of Pulmonary Hypertension, run by University of Giessen at 1 site in Germany.
Trial summary
Giessen Pulmonary Hypertension Registry and Biobank Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Hypertension
- How many people
- 10,000 participants
- Where
- 1 siteGermany
- Study dates
- Jul 1993to 15 Jan 2036
- How long will I take part?
- 20 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: Study population includes patients referred to our tertial PH expert center in Giessen with suspected PH.
Who may be able to join
- Right heart catheterization for PH diagnosis in Giessen
Who cannot join
- informed consent missing
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Intermal Medicine - Universities of Giessen and Marburg Lung Center
Giessen, 35392
Khodr Tello, MD, 0641/985-51250, khodr.tello@innere.med.uni-giessen.de
About this study
Giessen Pulmonary Hypertension Registry and Biobank
Read the detailed description
Long-term transplant-free survival and its determinants will be investigated in patients with Pulmonary Hypertension (diagnosed by right heart catheterization) within a prospective registry at a single referral center in Giessen, Germany.
- 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 | Group 1 PH | |
| Pulmonary hypertension due to left heart disease | Group 2 PH | |
| Pulmonary hypertension due to lung disease | Group 3 PH | |
| Chronic thromboembolic pulmonary hypertension | Group 4 PH | |
| Miscellaneous | Group 5 PH | |
| Exclusion PH | Patient with invasively excluded PH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Transplant-free survival of PH patients
Measured: Up to 20 years after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study startJul 1993
- Primary completion15 Jul 2035 (estimated)
- Study completion15 Jan 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary 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
- 10,000 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Khodr Tello, MD, Principal investigator, University Clinics of Giessen and Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04145024
- Sponsor's protocol ID
- 2001
- Status last verified
- Dec 2024
- First submitted
- 28 Oct 2019
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gall H, Felix JF, Schneck FK, Milger K, Sommer N, Voswinckel R, Franco OH, Hofman A, Schermuly RT, Weissmann N, Grimminger F, Seeger W, Ghofrani HA. The Giessen Pulmonary Hypertension Registry: Survival in pulmonary hypertension subgroups. J Heart Lung Transplant. 2017 Sep;36(9):957-967. doi: 10.1016/j.healun.2017.02.016. Epub 2017 Feb 17.
PubMed 28302503
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Giessen Pulmonary Hypertension Registry and Biobank
- ClinicalTrials.gov ID
- NCT04145024
- Acronym / sponsor ID
- 2001
- Conditions
- Pulmonary Hypertension
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Study start
- Jul 1993 (actual)
- Primary completion
- 15 Jul 2035 (estimated)
- Study completion
- 15 Jan 2036 (estimated)
- First posted
- 30 Oct 2019 (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.
Giessen Pulmonary Hypertension Registry and Biobank
Detailed description
Long-term transplant-free survival and its determinants will be investigated in patients with Pulmonary Hypertension (diagnosed by right heart catheterization) within a prospective registry at a single referral center in Giessen, Germany.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Pulmonary arterial hypertension | – | –Group 1 PH |
| Pulmonary hypertension due to left heart disease | – | –Group 2 PH |
| Pulmonary hypertension due to lung disease | – | –Group 3 PH |
| Chronic thromboembolic pulmonary hypertension | – | –Group 4 PH |
| Miscellaneous | – | –Group 5 PH |
| Exclusion PH | – | –Patient with invasively excluded PH |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study population includes patients referred to our tertial PH expert center in Giessen with suspected PH.
Key inclusion criteria (1 listed)
- Right heart catheterization for PH diagnosis in Giessen
Key exclusion criteria (1 listed)
- informed consent missing
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
Survival
Time frame: Up to 20 years after enrollment
Transplant-free survival of PH patients
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 11 Dec 2024.
- Results publication: PubMed 28302503Gall H, Felix JF, Schneck FK, Milger K, Sommer N, Voswinckel R, Franco OH, Hofman A, Schermuly RT, Weissmann N, Grimminger F, Seeger W, Ghofrani HA. The Giessen Pulmonary Hypertension Registry: Survival in pulmonary hypertension subgroups. J Heart Lung Transplant. 2017 Sep;36(9):957-967. doi: 10.1016/j.healun.2017.02.016. Epub 2017 Feb 17.
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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.
Khodr Tello, MD principal investigator
University Clinics of Giessen and Marburg
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 Giessen at 1 site in Germany.
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 11 Dec 2024. 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 Germany. 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 Khodr Tello, MD (0641/985-51250 ext. 57030, khodr.tello@innere.med.uni-giessen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: Up to 20 years after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04145024, which also lists 1 linked publication.
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 11 Dec 2024.