NCT04993612 Postcapillary Blood Gas Analysis in Wedge Position (Wedge-BGA)
| NCT ID | NCT04993612 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ayham Daher |
| Condition | Pulmonary Hypertension |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2021-06-25 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2021-06-25 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * Patients who have a clearly defined indication for Right heart catheterization. * Age \> 18 years * Informed consent for participation in the study will sign Exclusion Criteria: * 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
Frequently Asked Questions
Who can join the NCT04993612 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Pulmonary Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04993612 currently recruiting?
Yes, NCT04993612 is actively recruiting participants. Visit ClinicalTrials.gov or contact Ayham Daher to inquire about joining.
Where is the NCT04993612 trial being conducted?
This trial is being conducted at Aachen, Germany.
Who is sponsoring the NCT04993612 clinical trial?
NCT04993612 is sponsored by Ayham Daher. The trial plans to enroll 100 participants.