Pulmonary HypertensionNCT05935865
Monitoring of the Influence of Approved PH-therapies RV-PA Coupling
An observational study of Pulmonary Hypertension, run by University of Giessen at 1 site in Germany.
Trial summary
The goal of this observational study is to learn about the acute (days) changes in right ventricular functions caused by initiation of pharmacological therapies in patients with precapillary pulmonary hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 13 Feb 2023to 13 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes patients with pre-capillary pulmonary hypertension (Nice classification groups 1, 3, or 4) who are scheduled to undergo right heart catheterization for clinical reasons as part of invasive diagnostics for: 1. Establishing a diagnosis when there is a non-invasive suspicion of pulmonary hypertension. 2. Performing invasive hemodynamic assessment in patients already receiving vasoactive therapy, with the question of therapy escalation, particularly in cases of right cardiac decompensation.
Who may be able to join
- Initial diagnosis of PH (treatment-naive incident PH) of the Nice classifications 1 (PAH), 3 (PH related to lung diseases/hypoxia), and 4 (CTEPH), or known PH under ongoing vasoreactive therapy
- No contraindications for right heart catheterization, conductance catheterization, or CorLog implantation
- Written consent from the patient or their legal guardian
Who cannot join
- Absence of written consent
- Invasive exclusion of PH
- Age < 18 years
- Presence of contraindications for right heart catheterization, conductance catheterization, or CorLog implantation
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Internal Medicine, Justus Liebig University Giessen, Universities of Giessen and Marburg Lung Center (UGMLC), German Center for Lung Research (DZL)
Giessen, Hesse, 35392
Khodr Tello, MD, +49 (0)641 985 56022, khodr.tello@innere.med.uni-giessen.de
About this study
The goal of this observational study is to learn about the acute (days) changes in right ventricular functions caused by initiation of pharmacological therapies in patients with precapillary pulmonary hypertension. The main question it aims to answer is:
- Course of afterload and intrinsic contractility throughout the hospital stay Participants will be equipped with a device for continuous monitoring and recording of the right ventricular pressure signal.
Read the detailed description
Pulmonary hypertension (PH) arises as a result of a vascular pathology affecting the pulmonary vessels, leading to an increase in resistance within the pulmonary circulation. The ability of the right ventricle to adapt to the elevated pressures caused by increased afterload is crucial for the progression and symptoms of the disease. This adaptation of the right ventricle to its afterload is referred to as ventriculoarterial coupling or RV-PA coupling, described by the ratio of contractility to afterload. Invasive pressure-volume loops (PV loops) are the gold standard for assessing RV-PA coupling. The loss of RV-PA coupling is considered a crucial factor in the development of right heart failure, the leading cause of mortality in patients with pulmonary hypertension. Therefore, reliable assessment of right cardiac function is essential for physicians to make informed decisions regarding further invasive diagnostics or therapy adjustments. Approved medications for the treatment of pulmonary arterial hypertension primarily induce pulmonary vasodilation, leading to a reduction in right ventricular afterload. The effects on right ventricular contractility and function, as represented by RV-PA coupling, are currently poorly understood and may not be consistent. In this study, 100 patients with PH requiring an inpatient stay for right heart catheterization will be equipped with a mobile, wireless system for invasive measurement of right ventricular pressure - the CorLog system (emka MEDICAL, Aschaffenburg, Germany). By combining continuously recorded pressure profiles with 3D echocardiographic volumetry, we will be able to generate PV loops and assess RV-PA coupling at various time points. The continuous monitoring of right ventricular pressure profiles throughout the entire hospital stay will allow us to capture the effects of newly initiated or expanded pulmonary vascular therapy on RV-PA coupling not only immediately but over several days. Furthermore, the 3D echocardiographic datasets will be analyzed using specialized software (ReVISION®, Argus Cognitive, Inc, Lebanon, NH) to mechanistically quantify the right ventricular contraction pattern and capture the immediate impact of pulmonary vasoreactive therapy on it. Additionally, a data pool will be created to validate the calculation of ejection fraction and RV-PA coupling based solely on pressure signals.
- Conditions
- Pulmonary Hypertension
- Keywords
- Monitoring, RV-PA Coupling, Pulmonary Hypertension, Right Ventricle
- Medical subject headings
- Hypertension, Pulmonary
What is being measured
The primary outcome is the main question the study is designed to answer.
Afterload
Responce of afterload (calculated from PV loops [Ea]) afterload during hospitalization to the initiation or escalation of pulmonary vascular therapy
Measured: 3-7days
Contractility
Response of contractility (calculated from PV loops [Ees]) during hospitalization to the initiation or escalation of pulmonary vascular therapy
Measured: 3-7days
Coupling
Response of Coupling (calculated from PV loops [Ees/Ea]) during hospitalization to the initiation or escalation of pulmonary vascular therapy
Measured: 3-7days
Validation of Echo/CorLog PV-Loops
Validation of Echo/Corlog-generated PV loops based on conductance catheter-generated PV loops
Measured: On first day
Secondary outcomes (2)
Validation of pressure-only methods
Validation of methods for calculating ejection fraction and RV-PA coupling using ventricular pressure signals
Measured: 3-7days
Contraction patterns
Analysis of volumetric datasets of the right ventricle using ReVISION software. Isolated quantification of right ventricular systolic shortening along the ventricular axes in 3-dimensional space.
Measured: 3-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start13 Feb 2023
- Primary completion13 Feb 2025 (estimated)
- Study completion13 Feb 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05935865
- Sponsor's protocol ID
- 211/22
- Status last verified
- Jun 2023
- First submitted
- 28 Jun 2023
- Last updated
- 7 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of the Influence of Approved PH-therapies RV-PA Coupling
- ClinicalTrials.gov ID
- NCT05935865
- Acronym / sponsor ID
- 211/22
- Conditions
- Pulmonary Hypertension
- Keywords
- Monitoring, RV-PA Coupling, Pulmonary Hypertension, Right Ventricle
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- 13 Feb 2025 (estimated)
- Study completion
- 13 Feb 2026 (estimated)
- First posted
- 7 Jul 2023 (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.
The goal of this observational study is to learn about the acute (days) changes in right ventricular functions caused by initiation of pharmacological therapies in patients with precapillary pulmonary hypertension. The main question it aims to answer is:
- Course of afterload and intrinsic contractility throughout the hospital stay Participants will be equipped with a device for continuous monitoring and recording of the right ventricular pressure signal.
Detailed description
Pulmonary hypertension (PH) arises as a result of a vascular pathology affecting the pulmonary vessels, leading to an increase in resistance within the pulmonary circulation. The ability of the right ventricle to adapt to the elevated pressures caused by increased afterload is crucial for the progression and symptoms of the disease. This adaptation of the right ventricle to its afterload is referred to as ventriculoarterial coupling or RV-PA coupling, described by the ratio of contractility to afterload. Invasive pressure-volume loops (PV loops) are the gold standard for assessing RV-PA coupling. The loss of RV-PA coupling is considered a crucial factor in the development of right heart failure, the leading cause of mortality in patients with pulmonary hypertension. Therefore, reliable assessment of right cardiac function is essential for physicians to make informed decisions regarding further invasive diagnostics or therapy adjustments. Approved medications for the treatment of pulmonary arterial hypertension primarily induce pulmonary vasodilation, leading to a reduction in right ventricular afterload. The effects on right ventricular contractility and function, as represented by RV-PA coupling, are currently poorly understood and may not be consistent. In this study, 100 patients with PH requiring an inpatient stay for right heart catheterization will be equipped with a mobile, wireless system for invasive measurement of right ventricular pressure - the CorLog system (emka MEDICAL, Aschaffenburg, Germany). By combining continuously recorded pressure profiles with 3D echocardiographic volumetry, we will be able to generate PV loops and assess RV-PA coupling at various time points. The continuous monitoring of right ventricular pressure profiles throughout the entire hospital stay will allow us to capture the effects of newly initiated or expanded pulmonary vascular therapy on RV-PA coupling not only immediately but over several days. Furthermore, the 3D echocardiographic datasets will be analyzed using specialized software (ReVISION®, Argus Cognitive, Inc, Lebanon, NH) to mechanistically quantify the right ventricular contraction pattern and capture the immediate impact of pulmonary vasoreactive therapy on it. Additionally, a data pool will be created to validate the calculation of ejection fraction and RV-PA coupling based solely on pressure signals.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes patients with pre-capillary pulmonary hypertension (Nice classification groups 1, 3, or 4) who are scheduled to undergo right heart catheterization for clinical reasons as part of invasive diagnostics for: 1. Establishing a diagnosis when there is a non-invasive suspicion of pulmonary hypertension. 2. Performing invasive hemodynamic assessment in patients already receiving vasoactive therapy, with the question of therapy escalation, particularly in cases of right cardiac decompensation.
Key inclusion criteria (3 listed)
- Initial diagnosis of PH (treatment-naive incident PH) of the Nice classifications 1 (PAH), 3 (PH related to lung diseases/hypoxia), and 4 (CTEPH), or known PH under ongoing vasoreactive therapy
- No contraindications for right heart catheterization, conductance catheterization, or CorLog implantation
- Written consent from the patient or their legal guardian
Key exclusion criteria (5 listed)
- Absence of written consent
- Invasive exclusion of PH
- Age < 18 years
- Presence of contraindications for right heart catheterization, conductance catheterization, or CorLog implantation
- Pregnancy or breastfeeding
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
Afterload
Time frame: 3-7days
Responce of afterload (calculated from PV loops [Ea]) afterload during hospitalization to the initiation or escalation of pulmonary vascular therapy
Contractility
Time frame: 3-7days
Response of contractility (calculated from PV loops [Ees]) during hospitalization to the initiation or escalation of pulmonary vascular therapy
Coupling
Time frame: 3-7days
Response of Coupling (calculated from PV loops [Ees/Ea]) during hospitalization to the initiation or escalation of pulmonary vascular therapy
Validation of Echo/CorLog PV-Loops
Time frame: On first day
Validation of Echo/Corlog-generated PV loops based on conductance catheter-generated PV loops
2 secondary outcomes
Validation of pressure-only methods
Time frame: 3-7days
Contraction patterns
Time frame: 3-7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
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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. This study is not recruiting at the moment.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 7 Jul 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Khodr Tello, MD (+49 (0)641 985 56022, 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?
Afterload (time frame: 3-7days). The study lists 4 primary outcomes in all. 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 7 Jul 2023.