Pulmonary HypertensionNCT04993612
Postcapillary Blood Gas Analysis in Wedge Position (Wedge-BGA)
An observational study of Pulmonary Hypertension, run by Ayham Daher at 1 site in Germany.
Trial summary
If pulmonary hypertension is suspected, a right heart catheterization is usually performed to confirm or rule out the diagnosis. As part of this examination, blood samples are taken from various locations as standard and blood gas analyses are performed. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Blood gas analysis
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 25 Jun 2021to 30 Jun 2026
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients receiving right heart catheterization for appropriate indications will be interviewed for their consent to participate in the study
Who may be able to join
- Patients who have a clearly defined indication for Right heart catheterization.
- Age > 18 years
- Informed consent for participation in the study will sign
Who cannot join
- Individuals who are not fully capable of giving consent and understanding the nature, significance, and scope of the study
- Pregnancy and lactation
- Wedge-BGA not possible
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
University Hospital RWTH Aachen
Aachen, 52062
Ayham Daher, M.D., +492418088763, adaher@ukaachen.de
About this study
Official title: Blood Gas Analysis Obtained in Pulmonary Capillary Wedge Position During Right Heart Catheterization
If pulmonary hypertension is suspected, a right heart catheterization is usually performed to confirm or rule out the diagnosis. As part of this examination, blood samples are taken from various locations as standard and blood gas analyses are performed. One of the most important measurements during the right heart catheterization is the measurement of the pulmonary arterial occlusion pressure by the so-called wedge maneuver. To measure this value, the catheter with inflated balloon must be advanced into the pulmonary vessels until the "wedge" position is reached, i.e. the balloon completely occludes a branch of the pulmonary artery. In this study, the investigators want to characterize patients with pulmonary hypertension of different causes in more detail. To do that, two blood samples (totaling approximately 4 mL of blood, one sample directly after occlusion and the other one two minutes later) will be drawn during the right heart catheterization from the above-mentioned "wedge" position", behind the inflated balloon, and blood gas analyses will be performed on these samples. In addition, various clinical parameters (comorbidities, etc.) will be recorded by means of clinical questionnaires. Follow-up data will be analyzed and correlations with the aforementioned blood gas analyses will be examined. The results of the study will be used to more precisely characterize the still vague concept of secondary pulmonary hypertension. This could help to develop new therapeutic strategies in some subgroups in the future.
- Conditions
- Pulmonary Hypertension
- Being tested
- Blood gas analysis
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood gas analysisDiagnostic test
Two blood samples will be drawn from the "wedge" position", behind the inflated balloon, during the right heart catheterization, and blood gas analyses will be performed. First sample will be drawn directly after inflating the ballon, and the second one 2 minutes later.
| Study group | Role | What they receive |
|---|---|---|
| No pulmonary Hypertension | Not described Receives: Diagnostic Test: Blood gas analysis | |
| pulmonary Hypertension Group 1 | Not described Receives: Diagnostic Test: Blood gas analysis | |
| pulmonary Hypertension Group 2 | Not described Receives: Diagnostic Test: Blood gas analysis | |
| pulmonary Hypertension Group 3 | Not described Receives: Diagnostic Test: Blood gas analysis | |
| pulmonary Hypertension Group 4 | Not described Receives: Diagnostic Test: Blood gas analysis | |
| pulmonary Hypertension Group 5 | Not described Receives: Diagnostic Test: Blood gas analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between group differences
Differences in the Wedge-BGA between groups
Measured: At the time of recruitment
Secondary outcomes (1)
Follow-up
Risk stratification and mortality after 1 and 5 years
Measured: 1 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start25 Jun 2021
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (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.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ayham Daher
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ayham Daher, RWTH Aachen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04993612
- Sponsor's protocol ID
- 21-063
- Status last verified
- Jan 2026
- First submitted
- 30 Jul 2021
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Gas Analysis Obtained in Pulmonary Capillary Wedge Position During Right Heart Catheterization
- ClinicalTrials.gov ID
- NCT04993612
- Acronym / sponsor ID
- 21-063
- Conditions
- Pulmonary Hypertension
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ayham DaherUniversity, hospital or other
- Study start
- 25 Jun 2021 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 6 Aug 2021 (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.
If pulmonary hypertension is suspected, a right heart catheterization is usually performed to confirm or rule out the diagnosis. As part of this examination, blood samples are taken from various locations as standard and blood gas analyses are performed. One of the most important measurements during the right heart catheterization is the measurement of the pulmonary arterial occlusion pressure by the so-called wedge maneuver. To measure this value, the catheter with inflated balloon must be advanced into the pulmonary vessels until the "wedge" position is reached, i.e. the balloon completely occludes a branch of the pulmonary artery. In this study, the investigators want to characterize patients with pulmonary hypertension of different causes in more detail. To do that, two blood samples (totaling approximately 4 mL of blood, one sample directly after occlusion and the other one two minutes later) will be drawn during the right heart catheterization from the above-mentioned "wedge" position", behind the inflated balloon, and blood gas analyses will be performed on these samples. In addition, various clinical parameters (comorbidities, etc.) will be recorded by means of clinical questionnaires. Follow-up data will be analyzed and correlations with the aforementioned blood gas analyses will be examined. The results of the study will be used to more precisely characterize the still vague concept of secondary pulmonary hypertension. This could help to develop new therapeutic strategies in some subgroups in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| No pulmonary Hypertension | – | Diagnostic Test: Blood gas analysis |
| pulmonary Hypertension Group 1 | – | Diagnostic Test: Blood gas analysis |
| pulmonary Hypertension Group 2 | – | Diagnostic Test: Blood gas analysis |
| pulmonary Hypertension Group 3 | – | Diagnostic Test: Blood gas analysis |
| pulmonary Hypertension Group 4 | – | Diagnostic Test: Blood gas analysis |
| pulmonary Hypertension Group 5 | – | Diagnostic Test: Blood gas analysis |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients receiving right heart catheterization for appropriate indications will be interviewed for their consent to participate in the study
Key inclusion criteria (3 listed)
- Patients who have a clearly defined indication for Right heart catheterization.
- Age > 18 years
- Informed consent for participation in the study will sign
Key exclusion criteria (3 listed)
- Individuals who are not fully capable of giving consent and understanding the nature, significance, and scope of the study
- Pregnancy and lactation
- Wedge-BGA not possible
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 |
|---|---|---|
| Blood gas analysisTwo blood samples will be drawn from the "wedge" position", behind the inflated balloon, during the right heart catheterization, and blood gas analyses will be performed. First sample will be drawn directly after inflating the ballon, and the second one 2 minutes later. | Diagnostic test | No pulmonary Hypertension, pulmonary Hypertension Group 1, pulmonary Hypertension Group 2, pulmonary Hypertension Group 3, pulmonary Hypertension Group 4, pulmonary Hypertension Group 5 |
Primary outcome
Between group differences
Time frame: At the time of recruitment
Differences in the Wedge-BGA between groups
1 secondary outcome
Follow-up
Time frame: 1 and 5 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 6 Feb 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Pulmonary Hypertension
RecruitingPhase 2
Study to Evaluate Sotatercept (MK-7962) in Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-008)
Pulmonary Arterial Hypertension
Active, not recruitingPhase 2
Effect of a Parenteral Emulsion With Omega3 on Neonates With PPHN and CDH
Pulmonary Hypertension of Newborn, Diaphragm Defect
Active, not recruitingObservational study
An Open-Label ProSpective MultiCENTer Study to Evaluate Safety and Tolerability of Dry Powder Inhaled Treprostinil in PH
Pulmonary Hypertension, Interstitial Lung Disease
Active, not recruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH
RecruitingPhase 2
Spironolactone for Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension
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.
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 Ayham Daher 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 3 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: looking for participants now, as of the sponsor's last update on 6 Feb 2026. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Between group differences (time frame: At the time of recruitment). 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 6 Feb 2026.