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

N/ANot Yet RecruitingNCT07483203

Mayo Clinic600 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

600

Conditions

Pulmonary Vascular Disease Valvular Heart Disease

Interventions

EchocardiogramDIAGNOSTIC_TEST

An echocardiogram will be performed during the patient's routinely scheduled right heart catheterization.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Tricuspid Regurgitation (TR) reduction

Tricuspid Regurgitation (TR) reduction will be defined as ≥1 grade reduction

Time frame: Baseline, 12 months

Right Ventricular function improvement

Right Ventricular function improvement will be defined as ≥5% in Right Ventricular free wall longitudinal strain

Time frame: Baseline, 12 months

Secondary Outcomes

Number of Hospitalizations

Number of Hospitalizations will be determined by the number of patients admitted to the hospital post procedure

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: Baseline

Tricuspid annular plane systolic excursion (TAPSE)

Central Contacts

Annabelle Fuenffinger

CONTACT

507-422-3801 fuenffinger.annabelle@mayo.edu

Data from ClinicalTrials.gov

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