Postcapillary Blood Gas Analysis in Wedge Position (Wedge... | NCT04993612

Studies
Postcapillary Blood Gas Analysis in Wedge Position (Wedge-BGA)

NCT04993612

Sponsor

Ayham Daher

Status

Recruiting

Last Update Posted

Feb 6, 2026Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Pulmonary Hypertension

Interventions

Blood gas analysis

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 25, 2021Actual

Primary Completion Date

Jun 30, 2026Estimated

Completion Date

Jun 30, 2026Estimated

First Submitted Date

Jul 30, 2021

First Submission Date that Met QC Criteria

Jul 30, 2021

First Posted Date

Aug 6, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 3, 2026

Last Update Posted Date

Feb 6, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ayham Daher, Principal Investigator, RWTH Aachen UniversitySponsor-Investigator

Lead Sponsor

Ayham DaherOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood gas analysis	Diagnostic 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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Between group differences	Differences in the Wedge-BGA between groups	At the time of recruitment

Secondary Outcomes

Measure	Description	Time Frame
Follow-up	Risk stratification and mortality after 1 and 5 years	1 and 5 years

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

All patients receiving right heart catheterization for appropriate indications will be interviewed for their consent to participate in the study

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital RWTH Aachen	Recruiting	Aachen		52062	Germany

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006976	Hypertension, Pulmonary

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D006973	Hypertension
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001784	Blood Gas Analysis

Ancestor Terms

ID	Term
D001774	Blood Chemical Analysis
D019963	Clinical Chemistry Tests
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided