Recruiting NCT07483203
A Study Of Clinical Implications Of Pulmonary Vascular Disease In Valvular Heart Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Echocardiogram.
- Who it may be relevant to
- Registry conditions: Pulmonary Vascular Disease, Valvular Heart Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical Implications of Pulmonary Vascular Disease in Valvular Heart Disease
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.
Interventions
- Diagnostic test Echocardiogram
An echocardiogram will be performed during the patient's routinely scheduled right heart catheterization.
Primary outcome measures
- Tricuspid Regurgitation (TR) reduction [Time frame: Baseline, 12 months]
- Right Ventricular function improvement [Time frame: Baseline, 12 months]
Secondary outcome measures (5)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT07483203 · 26-000174