NCT04993612

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
2mo left

Started Jun 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress97%
Jun 2021Jun 2026

Study Start

First participant enrolled

June 25, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 30, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 6, 2021

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

February 6, 2026

Status Verified

January 1, 2026

Enrollment Period

5 years

First QC Date

July 30, 2021

Last Update Submit

February 3, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Between group differences

    Differences in the Wedge-BGA between groups

    At the time of recruitment

Secondary Outcomes (1)

  • Follow-up

    1 and 5 years

Study Arms (6)

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

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.

No pulmonary Hypertensionpulmonary Hypertension Group 1pulmonary Hypertension Group 2pulmonary Hypertension Group 3pulmonary Hypertension Group 4pulmonary Hypertension Group 5

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Patients who have a clearly defined indication for Right heart catheterization.
  • Age \> 18 years
  • Informed consent for participation in the study will sign

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital RWTH Aachen

Aachen, 52062, Germany

RECRUITING

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Blood Gas Analysis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 30, 2021

First Posted

August 6, 2021

Study Start

June 25, 2021

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

February 6, 2026

Record last verified: 2026-01

Locations