Pulmonary Vascular DiseaseNCT07483203
A Study Of Clinical Implications Of Pulmonary Vascular Disease In Valvular Heart Disease
An observational study of Pulmonary Vascular Disease and Valvular Heart Disease, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to characterize pulmonary hemodynamic profiles, with a focus on PVR subtypes, in patients with left-sided valvular heart disease undergoing aortic or mitral valve intervention, and to identify patterns predicting reversibility of TR and RV dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Vascular Disease, Valvular Heart Disease
- What is being tested?
- Echocardiogram
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2026to May 2028
- 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 consist of patients scheduled to undergo transcatheter aortic, mitral, or tricuspid valve interventions at Mayo Clinic Rochester.
Who may be able to join
- ≥18 years old; AND
- Scheduled for valve procedures
Who cannot join
- Congenital heart disease (except for bicuspid aortic valve), OR
- Carcinoid heart disease, OR
- Valvular mass, OR
- Endocarditis, OR
- Any other condition that, in the opinion of the investigator, would impair their ability to complete the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Dr. Borlaug's Research Team, (507) 255-2200
Barry Borlaug, MD, (507) 255-1051, Borlaug.Barry@mayo.edu
About this study
Official title: Clinical Implications of Pulmonary Vascular Disease in Valvular Heart Disease
The purpose of this study is to characterize pulmonary hemodynamic profiles, with a focus on PVR subtypes, in patients with left-sided valvular heart disease undergoing aortic or mitral valve intervention, and to identify patterns predicting reversibility of TR and RV dysfunction.
- Conditions
- Pulmonary Vascular Disease, Valvular Heart Disease
- Being tested
- Echocardiogram
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiogramDiagnostic test
An echocardiogram will be performed during the patient's routinely scheduled right heart catheterization.
| Study group | Role | What they receive |
|---|---|---|
| Aortic Intervention | Not described Receives: Diagnostic Test: Echocardiogram | |
| Mitral Intervention | Not described Receives: Diagnostic Test: Echocardiogram | |
| Tricuspid intervention | Not described Receives: Diagnostic Test: Echocardiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tricuspid Regurgitation (TR) reduction
Tricuspid Regurgitation (TR) reduction will be defined as ≥1 grade reduction
Measured: Baseline, 12 months
Right Ventricular function improvement
Right Ventricular function improvement will be defined as ≥5% in Right Ventricular free wall longitudinal strain
Measured: Baseline, 12 months
Secondary outcomes (5)
Number of Hospitalizations
Number of Hospitalizations will be determined by the number of patients admitted to the hospital post procedure
Measured: 12 months
Number of Deaths
Number of Death will be determined by the number of patients that pass away post procedure due to any cause
Measured: 12 months
Kansas City Cardiomyopathy Questionnaire (KCCQ)
KCCQ is a 12-item questionnaires that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. Scores were generated for each domain and scaled from 0 to 70, with 0 (worst) and 70 (the best possible status), where the higher score reflected better health status.
Measured: Baseline, 6 months, and 12 months
Right atrial area change
Right atrial area change is used to assess right vascular function. It will measure the area of change within the right ventricle between diastole and systole as a percentage.
Measured: Baseline
Tricuspid annular plane systolic excursion (TAPSE)
Tricuspid annular plane systolic excursion will be used to measure right ventricular function and measured in mm (millimeters)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start28 Apr 2026
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Vascular DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barry Borlaug, Mayo Clinic
- Investigators
- Barry Borlaug, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07483203
- Sponsor's protocol ID
- 26-000174
- Status last verified
- Jun 2026
- First submitted
- 16 Mar 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Implications of Pulmonary Vascular Disease in Valvular Heart Disease
- ClinicalTrials.gov ID
- NCT07483203
- Acronym / sponsor ID
- 26-000174
- Conditions
- Pulmonary Vascular Disease, Valvular Heart Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 28 Apr 2026 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 19 Mar 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.
The purpose of this study is to characterize pulmonary hemodynamic profiles, with a focus on PVR subtypes, in patients with left-sided valvular heart disease undergoing aortic or mitral valve intervention, and to identify patterns predicting reversibility of TR and RV dysfunction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aortic Intervention | – | Diagnostic Test: Echocardiogram |
| Mitral Intervention | – | Diagnostic Test: Echocardiogram |
| Tricuspid intervention | – | Diagnostic Test: Echocardiogram |
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 consist of patients scheduled to undergo transcatheter aortic, mitral, or tricuspid valve interventions at Mayo Clinic Rochester.
Key inclusion criteria (2 listed)
- ≥18 years old; AND
- Scheduled for valve procedures
Key exclusion criteria (5 listed)
- Congenital heart disease (except for bicuspid aortic valve), OR
- Carcinoid heart disease, OR
- Valvular mass, OR
- Endocarditis, OR
- Any other condition that, in the opinion of the investigator, would impair their ability to complete the study
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 |
|---|---|---|
| EchocardiogramAn echocardiogram will be performed during the patient's routinely scheduled right heart catheterization. | Diagnostic test | Aortic Intervention, Mitral Intervention, Tricuspid intervention |
Primary outcome
Tricuspid Regurgitation (TR) reduction
Time frame: Baseline, 12 months
Tricuspid Regurgitation (TR) reduction will be defined as ≥1 grade reduction
Right Ventricular function improvement
Time frame: Baseline, 12 months
Right Ventricular function improvement will be defined as ≥5% in Right Ventricular free wall longitudinal strain
5 secondary outcomes
Number of Hospitalizations
Time frame: 12 months
Number of Deaths
Time frame: 12 months
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: Baseline, 6 months, and 12 months
Right atrial area change
Time frame: Baseline
Tricuspid annular plane systolic excursion (TAPSE)
Time frame: Baseline
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 18 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Barry Borlaug, MD principal investigator
Mayo Clinic
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 Vascular Disease and Valvular Heart Disease, run by Mayo Clinic at 1 site in United States.
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 2 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: looking for participants now, as of the sponsor's last update on 18 Jun 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 United States. 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 Annabelle Fuenffinger (507-422-3801, fuenffinger.annabelle@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tricuspid Regurgitation (TR) reduction (time frame: Baseline, 12 months). The study lists 2 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 18 Jun 2026.