Heart FailureVHD-PV-loopNCT07112391
Pressure-Volume Loop Assessment in Valvular Heart Disease
An observational study of Heart Failure and Structural Heart Disease, run by Nantes University Hospital at 1 site in France.
Trial summary
The VHD PV loop study intends to assess invasive right ventricular to pulmonary artery (RV-PA) coupling in patients with valvular heart disease (VHD). Invasive RV-PA coupling is measured by using conductance catheters, the gold standard assessment for ventricular physiology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Structural Heart Disease, Interventional Cardiology
- What is being tested?
- Observational Invasive Hemodynamic Assessment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 4 Sep 2025to 4 Sep 2027
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include patients referred to Nantes University Hospital for the treatment of significant VHD.
Who may be able to join
- Adult patients (≥ 18 years old);
- Patients with severe structural heart disease (meeting at least one of the following three criteria):
- Heart failure with moderate-to-severe or severe secondary mitral regurgitation
- At least severe tricuspid regurgitation
- Significant pulmonary valve stenosis and/or regurgitation
Who cannot join
- Patients under legal guardianship or protection (e.g., guardianship, trusteeship, or any other legal protection measure);
- Pregnant or breastfeeding women;
- Vulnerable individuals (e.g., persons deprived of liberty, adults under legal protection);
- Contraindication to right heart catheterization, including:
- Known proximal venous occlusion of the superior or inferior vena cava territory
- Presence of a mobile mass in the right heart chambers
- Significant tricuspid stenosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU of NANTES
Nantes, Loire Atlantique, 44000
ROBIN LE RUZ, cardiologist, MD, 02 53 48 28 35, robin.leruz@chu-nantes.fr
About this study
Official title: Invasive Hemodynamic Study of Structural Heart Diseases: A Monocentric, Non-Randomized Approach
The VHD PV loop study intends to assess invasive right ventricular to pulmonary artery (RV-PA) coupling in patients with valvular heart disease (VHD). Invasive RV-PA coupling is measured by using conductance catheters, the gold standard assessment for ventricular physiology. Several non-invasive parameters have been reported as surrogates for this complex physiological entity, but none of them has been tested against the gold-standard in this population. Based on this, our main objective is to assess the correlation of imaging derived RV-PA coupling in comparison to the invasive measurement.
Read the detailed description
This study aims to improve the assessment of right ventricular (RV) function in patients with valvular heart disease (VHD), by validating non-invasive imaging parameters of right ventricular to pulmonary artery (RV-PA) coupling against invasive measurements using conductance catheters-the gold standard for evaluating RV hemodynamics.
Currently available non-invasive tools do not always provide reliable evaluation of RV-PA coupling. This study seeks to identify accurate imaging surrogates to support clinical decision-making, particularly in conditions such as secondary mitral regurgitation, tricuspid regurgitation, and right-sided structural heart disease.
By correlating non-invasive indices-such as tricuspid annular plane systolic excursion to pulmonary artery systolic pressure ratio (TAPSE/PASP) and RV strain-with invasive data, the study may enhance diagnostic strategies, improve patient care, and support future prognostic and therapeutic investigations. Data may also contribute to post hoc analyses in existing registries and help refine our understanding of RV adaptation in structural heart disease.
- Being tested
- Observational Invasive Hemodynamic Assessment
- Keywords
- Chronic heart failure, Structural heart disease, Interventional cardiology, Multimodality imaging
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational Invasive Hemodynamic AssessmentOther
Also called Cardiac Catheterization, Hemodynamic Procedure
Collection and analysis of invasive hemodynamic data obtained through routine cardiac catheterization performed as part of standard care. No intervention is mandated by the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Severe valvular heart disease | Patients with severe Valvular Heart Disease (VHD) will undergo a RV volumetric assessment (MRI, CT, 3D-echocardiography) followed within 72h by an invasive assessment of RV-PA coupling using conductance catheters, either as a preoperative evaluation or at the time of transcatheter valvular intervention. Echocardiographic images will be acquired during right heart catheterization (RHC) in order to be compared to the gold-standard. Receives: Other: Observational Invasive Hemodynamic Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation with non-invasive echocardiographic parameters
Assessment of diagnostic performances of TAPSE/PAPS, RVFWLS/PAPS and FAC/PAPS ratios compared to Ees/Ea ratio.
Measured: During right heart catheterization (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start4 Sep 2025
- Primary completion4 Sep 2027 (estimated)
- Study completion4 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fédération Française de Cardiologie
- Responsible party
- Sponsor
- Investigators
- Robin LE RUZ, MD, PhD, Principal investigator, Hospital of Nantes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07112391
- Sponsor's protocol ID
- RC25_0116
- Acronym
- VHD-PV-loop
- Status last verified
- Sep 2025
- First submitted
- 25 Jul 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Invasive Hemodynamic Study of Structural Heart Diseases: A Monocentric, Non-Randomized Approach
- ClinicalTrials.gov ID
- NCT07112391
- Acronym / sponsor ID
- VHD-PV-loop / RC25_0116
- Keywords
- Chronic heart failure, Structural heart disease, Interventional cardiology, Multimodality imaging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Fédération Française de Cardiologie
- Study start
- 4 Sep 2025 (actual)
- Primary completion
- 4 Sep 2027 (estimated)
- Study completion
- 4 Sep 2027 (estimated)
- First posted
- 8 Aug 2025 (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 VHD PV loop study intends to assess invasive right ventricular to pulmonary artery (RV-PA) coupling in patients with valvular heart disease (VHD). Invasive RV-PA coupling is measured by using conductance catheters, the gold standard assessment for ventricular physiology. Several non-invasive parameters have been reported as surrogates for this complex physiological entity, but none of them has been tested against the gold-standard in this population. Based on this, our main objective is to assess the correlation of imaging derived RV-PA coupling in comparison to the invasive measurement.
Detailed description
This study aims to improve the assessment of right ventricular (RV) function in patients with valvular heart disease (VHD), by validating non-invasive imaging parameters of right ventricular to pulmonary artery (RV-PA) coupling against invasive measurements using conductance catheters-the gold standard for evaluating RV hemodynamics.
Currently available non-invasive tools do not always provide reliable evaluation of RV-PA coupling. This study seeks to identify accurate imaging surrogates to support clinical decision-making, particularly in conditions such as secondary mitral regurgitation, tricuspid regurgitation, and right-sided structural heart disease.
By correlating non-invasive indices-such as tricuspid annular plane systolic excursion to pulmonary artery systolic pressure ratio (TAPSE/PASP) and RV strain-with invasive data, the study may enhance diagnostic strategies, improve patient care, and support future prognostic and therapeutic investigations. Data may also contribute to post hoc analyses in existing registries and help refine our understanding of RV adaptation in structural heart disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe valvular heart disease | – | Other: Observational Invasive Hemodynamic AssessmentPatients with severe Valvular Heart Disease (VHD) will undergo a RV volumetric assessment (MRI, CT, 3D-echocardiography) followed within 72h by an invasive assessment of RV-PA coupling using conductance catheters, either as a preoperative evaluation or at the time of transcatheter valvular intervention. Echocardiographic images will be acquired during right heart catheterization (RHC) in order to be compared to the gold-standard. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include patients referred to Nantes University Hospital for the treatment of significant VHD.
Key inclusion criteria (5 listed)
- Adult patients (≥ 18 years old);
- Patients with severe structural heart disease (meeting at least one of the following three criteria):
Key exclusion criteria (7 listed)
- Patients under legal guardianship or protection (e.g., guardianship, trusteeship, or any other legal protection measure);
- Pregnant or breastfeeding women;
- Vulnerable individuals (e.g., persons deprived of liberty, adults under legal protection);
- Contraindication to right heart catheterization, including:
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 |
|---|---|---|
| Observational Invasive Hemodynamic AssessmentAlso: Cardiac Catheterization, Hemodynamic ProcedureCollection and analysis of invasive hemodynamic data obtained through routine cardiac catheterization performed as part of standard care. No intervention is mandated by the study protocol. | Other | Severe valvular heart disease |
Primary outcome
Correlation with non-invasive echocardiographic parameters
Time frame: During right heart catheterization (Day 1)
Assessment of diagnostic performances of TAPSE/PAPS, RVFWLS/PAPS and FAC/PAPS ratios compared to Ees/Ea ratio.
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 16 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
Robin LE RUZ, MD, PhD principal investigator
Hospital of Nantes
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 Heart Failure and Structural Heart Disease, run by Nantes University Hospital at 1 site in France.
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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 16 Sep 2025. 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 France. 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?
Contact Robin LE RUZ, MD, PhD (02. 53.48.28.36, robin.leruz@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation with non-invasive echocardiographic parameters (time frame: During right heart catheterization (Day 1)). 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 16 Sep 2025.