A Study Of Clinical Implications Of Pulmonary Vascular Disease In Valvular Heart Disease

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Valvular Heart Disease; Pulmonary Vascular Disease
• Intervention / Treatment: Diagnostic test: Echocardiogram

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Annabelle Fuenffinger; Phone Number: 507-422-3801; Email: Fuenffinger.Annabelle@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study population will consist of patients scheduled to undergo transcatheter aortic, mitral, or tricuspid valve interventions at Mayo Clinic Rochester.

Description

Inclusion Criteria:

• ≥18 years old; AND
• Scheduled for valve procedures

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Aortic Intervention	Diagnostic test: Echocardiogram; An echocardiogram will be performed during the patient's routinely scheduled right heart catheterization.
Mitral Intervention	Diagnostic test: Echocardiogram; An echocardiogram will be performed during the patient's routinely scheduled right heart catheterization.
Tricuspid intervention	Diagnostic test: Echocardiogram; An echocardiogram will be performed during the patient's routinely scheduled right heart catheterization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tricuspid Regurgitation (TR) reduction	Tricuspid Regurgitation (TR) reduction will be defined as ≥1 grade reduction	Baseline, 12 months
Right Ventricular function improvement	Right Ventricular function improvement will be defined as ≥5% in Right Ventricular free wall longitudinal strain	Baseline, 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Hospitalizations	Number of Hospitalizations will be determined by the number of patients admitted to the hospital post procedure	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	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.	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.	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)	Baseline

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Barry Borlaug, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: March 16, 2026
• First Submitted That Met QC Criteria: March 16, 2026
• First Posted (Actual): March 19, 2026

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Diagnostic Techniques, Cardiovascular; Heart Function Tests; Cardiac Imaging Techniques; Ultrasonography; Echocardiography
• Other Study ID Numbers: 26-000174

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No