Pulmonary Vascular Hemodynamics Before and After Mitral Valve Procedures

The University of Alabama at Birmingham

Status: Withdrawn

Conditions: Pulmonary Hypertension

Treatments: Diagnostic Test: To discern micro-RNA specific for right and left heart induced PH

Study type: Observational

Funder types: Other

Identifiers

NCT04947384

IRB-300006686

UAB (Other Grant/Funding Number)

Details and patient eligibility

About

The objective of this proposal is to study circulating and echocardiographic markers of pulmonary vascular and right ventricular remodeling in patients with a WHO-2 diagnosis of pulmonary hypertension after mitral valve procedures. The investigators are proposing the study will be impactful for the early detection and prediction and of residual pulmonary hypertension (PH) that would otherwise be undetected and fatal with no curative treatment.

Full description

The investigators will enroll 3 groups: Group 1: Patients with established WHO-2 diagnosis of PH undergoing open and interventional mitral valve procedures. Group 2: Patients with no PH undergoing open and interventional mitral valve procedures. Group 3: Patients with established diagnosis of WHO-1-4 groups of PH undergoing right heart catheterization. Groups 2 and 3 will serve as controls. All procedures will be performed at the main UAB Hospital cardiac surgical operating rooms and at the cardiac angiographic suites. The investigators will collect a total of 3 blood samples; the first sample will be obtained on arterial cannulation before the initiation of the intervention, the second sample will be collected upon the end of the procedure prior to leaving the procedure room, and the third sample will be collected on the day of discharge from the hospital. A comprehensive echocardiogram at the 3 corresponding time points of the blood samples obtained; before, and after the intervention and before discharge.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• >= 18 years/old

Exclusion criteria

• Patients with ejection fraction (EF) < 35%
• Patients with severe tricuspid valve regurgitation
• Transplant patients
• Patients scheduled for ventricular assist devices
• Patients with a diagnosis of heart failure with preserved ejection fraction
• Any aortic valvular disease

Trial design

0 participants in 3 patient groups

Patients with moderate mitral valve disease, undergoing interventions

Description:

Patients with established WHO-2 diagnosis of PH undergoing open and interventional mitral valve procedures.

Treatment:

Diagnostic Test: To discern micro-RNA specific for right and left heart induced PH

Patients undergoing mitral valve interventions without pulmonary hypertension

Description:

Patients with no PH undergoing open and interventional mitral valve procedures. This group will serve as a control.

Treatment:

Diagnostic Test: To discern micro-RNA specific for right and left heart induced PH

Patients with precapillary pulmonary hypertension scheduled for right heart catheterization

Description:

Patients with established diagnosis of WHO-1-4 groups of PH undergoing right heart catheterization. This group will serve as a control.

Treatment:

Diagnostic Test: To discern micro-RNA specific for right and left heart induced PH