Pulmonary HypertensionNCT07742046
Feasibility of Non-invasive Hemodynamic Assessment by 5D Flow in Congenital Heart Disease
A study testing Right-left heart catheterization in magnetic resonance imaging (MRI) in people with Pulmonary Hypertension and Right Ventricular Outflow Tract Dysfunction, run by Tobias Rutz at 1 site in Switzerland.
Trial summary
This study evaluates whether new flow parameters of the cardiac magnetic resonance imaging (MRI) allow evaluation of parameters for which usually invasive rigth-left heart catheterization are necessary. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Pulmonary Hypertension, Right Ventricular Outflow Tract Dysfunction, Fontan Circulation
- What is being tested?
- Right-left heart catheterization in magnetic resonance imaging (MRI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteSwitzerland
- Study dates
- 6 Jul 2026to 31 May 2029
- Phase
- Interventional
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Referral for work-up of known or suspected pulmonary hypertension (PH), RVOT pathology, or Fontan-type repair with a clinical indication for RL-HC.
- Ability to provide informed consent or have consent provided by a legal representative (and assent for minors aged 16-18).
- Male or female participants of all ethnicities and sociodemographic backgrounds
Who cannot join
- Participants unable to comply with study procedures due to language barriers, cognitive or psychological limitations, or lack of legal consent.
- Patients with contraindications to RL-HC or CMR.
- Patients not having a clinical indication to RL-HC.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of the Feasibility of Non-invasive Hemodynamic Assessment by 5D Flow in Congenital Heart Disease in Comparison to Right-left Heart Catheterization
This study evaluates whether new flow parameters of the cardiac magnetic resonance imaging (MRI) allow evaluation of parameters for which usually invasive rigth-left heart catheterization are necessary. Patients who require a right-left heart catheterization will undergo the same day a heart catheterization in the MRI. Parameters obtained by MRI will be compared to the gold-standard, the right-left heart catheterization.
Read the detailed description
Because of progress in early diagnosis, surgery, and medical treatment, almost all patients with congenital heart disease (CHD) survive nowadays into adulthood. However, most patients cannot be considered as cured as they are at high risk for complications like heart failure, valvopathies and pulmonary arterial hypertension (PAH). Treatment and diagnosis of these complications require often repetitive right-left heart catheterizations (RL-HC) for hemodynamic evaluations which are associated with a procedural risk, particularly in young patients in addition to a repeated radiation exposure. Advanced flow parameters obtained by the recently introduced Cardiac Magnetic Resonance (CMR) 4D flow technique promise non-invasive evaluation of hemodynamic parameters like pressure gradients and vascular resistance opening the door to partially replace RL-HC. However, 4D flow is limited by the need for ECG detection and cardiac movement during respiration. A new fully self-gated 5D CMR framework to cardiac and respiratory motion-resolved 3D flow imaging-5D flow aims to overcome these limitations. In addition, respiratory resolved flow determination is possible. As a result, 5D flow is a potentially powerful tool for the non-invasive assessment of hemodynamics like filling pressures and vascular resistance.
In the proposed study, patients will undergo a CMR-guided RL-HC in addition to a clinically indicated RL-HC.
As CMR is the gold standard for non-invasive flow determination, the combination of CMR-derived flow and RL-HC-derived pressures allows a precise evaluation of vascular resistance as it overcomes the limitations of the classic invasive methods for determination of cardiac output like the Fick or thermodilution techniques and the radiation exposure. This is particularly interesting in CHD patients in whom e.g. pulmonary resistance can differ in both lungs. For this reason, CMR guided heart catheterization (iCMR) is therefore increasingly incorporated in the routine use in different centers.
This study evaluates the feasibility of the determination of the relationship between noninvasive advanced 5D flow parameters and invasive catheter-derived vascular and ventricular hemodynamic parameters in PH/PAH and CHD patients. This will help to improve diagnosis and knowledge of the pathophysiological mechanisms in these complex patients.
All patients will undergo a clinical indicated standard RL-HC. In Fontan patients, a liver biopsy will be performed which is part of the routine follow-up for these patients. The participants are transferred to the interventional CMR suite. A RL-HC will be performed under CMR control. Invasive pressure measurements will be performed at predefined positions. After the RL-HC, the 5D flow will be obtained as well as a standard cardiac magnetic resonance imaging for determination of ventricular function and standard 2D and 4D flow.
- Being tested
- Right-left heart catheterization in magnetic resonance imaging (MRI)
- Keywords
- 5D flow, cardiac magnetic resonance imaging, congenital heart disease, iCMR
- Medical subject headings
- Hypertension, Pulmonary, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Right-left heart catheterization in magnetic resonance imaging (MRI)Diagnostic test
Right-left heart catheterization in MRI
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing iCMR | Experimental | Patients undergoing iCMR Receives: Diagnostic Test: Right-left heart catheterization in magnetic resonance imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vorticity (s-1)
Vorticity is defined as the curl of the velocity quantifying the rotation around an axis of individual fluid particles. The parameters will be determined by the cardiac magnetic resonance 5D flow technique.
Measured: Periprocedural
Helicity (m⁴/s²)
Helicity quantifies the helical flow or flow with a corkscrew-like motion in one direction and is proportional to the velocity and the vorticity, reflecting stability of laminar flow The parameter will be determined by the cardiac magnetic resonance 5D flow technique.
Measured: Periprocedural
Pressure maps (mmHg)
With the the help of the cardiac magnetic resonance 5D flow technique a pressure map over a valvular/vascular stenosis will be determined
Measured: Periprocedural
Kinetic energy (KE) (J) and its loss (EL, J/m3)
Kinetic energy represents the amount of energy in the blood flow due to its motion.
This parameters will be determined by the cardiac magnetic resonance imaging 5D flow technique.
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start6 Jul 2026
- Primary completion31 May 2029 (estimated)
- Study completion31 May 2029 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tobias Rutz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tobias Rutz, University of Lausanne Hospitals
- Investigators
- Tobias Rutz, MD, Principal investigator, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07742046
- Sponsor's protocol ID
- 2025-01908
- Other IDs
- 320030-231872, 2025
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data can be shared upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Feasibility of Non-invasive Hemodynamic Assessment by 5D Flow in Congenital Heart Disease in Comparison to Right-left Heart Catheterization
- ClinicalTrials.gov ID
- NCT07742046
- Acronym / sponsor ID
- 2025-01908
- Keywords
- 5D flow, cardiac magnetic resonance imaging, congenital heart disease, iCMR
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Tobias RutzUniversity, hospital or other
- Study start
- 6 Jul 2026 (actual)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 3 Aug 2026 (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.
This study evaluates whether new flow parameters of the cardiac magnetic resonance imaging (MRI) allow evaluation of parameters for which usually invasive rigth-left heart catheterization are necessary. Patients who require a right-left heart catheterization will undergo the same day a heart catheterization in the MRI. Parameters obtained by MRI will be compared to the gold-standard, the right-left heart catheterization.
Detailed description
Because of progress in early diagnosis, surgery, and medical treatment, almost all patients with congenital heart disease (CHD) survive nowadays into adulthood. However, most patients cannot be considered as cured as they are at high risk for complications like heart failure, valvopathies and pulmonary arterial hypertension (PAH). Treatment and diagnosis of these complications require often repetitive right-left heart catheterizations (RL-HC) for hemodynamic evaluations which are associated with a procedural risk, particularly in young patients in addition to a repeated radiation exposure. Advanced flow parameters obtained by the recently introduced Cardiac Magnetic Resonance (CMR) 4D flow technique promise non-invasive evaluation of hemodynamic parameters like pressure gradients and vascular resistance opening the door to partially replace RL-HC. However, 4D flow is limited by the need for ECG detection and cardiac movement during respiration. A new fully self-gated 5D CMR framework to cardiac and respiratory motion-resolved 3D flow imaging-5D flow aims to overcome these limitations. In addition, respiratory resolved flow determination is possible. As a result, 5D flow is a potentially powerful tool for the non-invasive assessment of hemodynamics like filling pressures and vascular resistance.
In the proposed study, patients will undergo a CMR-guided RL-HC in addition to a clinically indicated RL-HC.
As CMR is the gold standard for non-invasive flow determination, the combination of CMR-derived flow and RL-HC-derived pressures allows a precise evaluation of vascular resistance as it overcomes the limitations of the classic invasive methods for determination of cardiac output like the Fick or thermodilution techniques and the radiation exposure. This is particularly interesting in CHD patients in whom e.g. pulmonary resistance can differ in both lungs. For this reason, CMR guided heart catheterization (iCMR) is therefore increasingly incorporated in the routine use in different centers.
This study evaluates the feasibility of the determination of the relationship between noninvasive advanced 5D flow parameters and invasive catheter-derived vascular and ventricular hemodynamic parameters in PH/PAH and CHD patients. This will help to improve diagnosis and knowledge of the pathophysiological mechanisms in these complex patients.
All patients will undergo a clinical indicated standard RL-HC. In Fontan patients, a liver biopsy will be performed which is part of the routine follow-up for these patients. The participants are transferred to the interventional CMR suite. A RL-HC will be performed under CMR control. Invasive pressure measurements will be performed at predefined positions. After the RL-HC, the 5D flow will be obtained as well as a standard cardiac magnetic resonance imaging for determination of ventricular function and standard 2D and 4D flow.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing iCMR | Experimental | Diagnostic Test: Right-left heart catheterization in magnetic resonance imaging (MRI)Patients undergoing iCMR |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Referral for work-up of known or suspected pulmonary hypertension (PH), RVOT pathology, or Fontan-type repair with a clinical indication for RL-HC.
- Ability to provide informed consent or have consent provided by a legal representative (and assent for minors aged 16-18).
- Male or female participants of all ethnicities and sociodemographic backgrounds
Key exclusion criteria (3 listed)
- Participants unable to comply with study procedures due to language barriers, cognitive or psychological limitations, or lack of legal consent.
- Patients with contraindications to RL-HC or CMR.
- Patients not having a clinical indication to RL-HC.
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 |
|---|---|---|
| Right-left heart catheterization in magnetic resonance imaging (MRI)Right-left heart catheterization in MRI | Diagnostic test | Patients undergoing iCMR |
Primary outcome
Vorticity (s-1)
Time frame: Periprocedural
Vorticity is defined as the curl of the velocity quantifying the rotation around an axis of individual fluid particles. The parameters will be determined by the cardiac magnetic resonance 5D flow technique.
Helicity (m⁴/s²)
Time frame: Periprocedural
Helicity quantifies the helical flow or flow with a corkscrew-like motion in one direction and is proportional to the velocity and the vorticity, reflecting stability of laminar flow The parameter will be determined by the cardiac magnetic resonance 5D flow technique.
Pressure maps (mmHg)
Time frame: Periprocedural
With the the help of the cardiac magnetic resonance 5D flow technique a pressure map over a valvular/vascular stenosis will be determined
Kinetic energy (KE) (J) and its loss (EL, J/m3)
Time frame: Periprocedural
Kinetic energy represents the amount of energy in the blood flow due to its motion. This parameters will be determined by the cardiac magnetic resonance imaging 5D flow technique.
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 3 Aug 2026.
- Individual participant dataSharing planned: Yes. Data can be shared upon reasonable request
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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.
Tobias Rutz, MD principal investigator
University of Lausanne Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Right-left heart catheterization in magnetic resonance imaging (MRI) in people with Pulmonary Hypertension and Right Ventricular Outflow Tract Dysfunction, run by Tobias Rutz at 1 site in Switzerland.
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: enrolling by invitation, as of the sponsor's last update on 3 Aug 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 Switzerland. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vorticity (s-1) (time frame: Periprocedural). 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 3 Aug 2026.