Pulmonary Vascular Disease, Valvular Heart Disease
Conditions
Brief 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.
Interventions
DIAGNOSTIC_TESTEchocardiogram
An echocardiogram will be performed during the patient's routinely scheduled right heart catheterization.
Sponsors
Mayo Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tricuspid Regurgitation (TR) reduction | Baseline, 12 months | Tricuspid Regurgitation (TR) reduction will be defined as ≥1 grade reduction |
| Right Ventricular function improvement | Baseline, 12 months | Right Ventricular function improvement will be defined as ≥5% in Right Ventricular free wall longitudinal strain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Hospitalizations | 12 months | Number of Hospitalizations will be determined by the number of patients admitted to the hospital post procedure |
| Number of Deaths | 12 months | Number of Death will be determined by the number of patients that pass away post procedure due to any cause |
| Kansas City Cardiomyopathy Questionnaire (KCCQ) | Baseline, 6 months, and 12 months | 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. |
| Right atrial area change | Baseline | 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. |
| Tricuspid annular plane systolic excursion (TAPSE) | Baseline | Tricuspid annular plane systolic excursion will be used to measure right ventricular function and measured in mm (millimeters) |
Countries
United States
Contacts
CONTACTAnnabelle Fuenffinger
PRINCIPAL_INVESTIGATORBarry Borlaug, MD
Mayo Clinic
Outcome results
None listed