Pulmonary Vascular Hemodynamics Before and After Mitral Valve Procedures
Overview
- Phase
- N/A
- Intervention
- To discern micro-RNA specific for right and left heart induced PH
- Conditions
- Pulmonary Hypertension
- Sponsor
- University of Alabama at Birmingham
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Biomarker analysis
- Status
- Withdrawn
- Last Updated
- 3 months ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Ahmed Zaky
Principal Investigator
University of Alabama at Birmingham
Eligibility Criteria
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
Arms & Interventions
Patients with moderate mitral valve disease, undergoing interventions
Patients with established WHO-2 diagnosis of PH undergoing open and interventional mitral valve procedures.
Intervention: To discern micro-RNA specific for right and left heart induced PH
Patients undergoing mitral valve interventions without pulmonary hypertension
Patients with no PH undergoing open and interventional mitral valve procedures. This group will serve as a control.
Intervention: To discern micro-RNA specific for right and left heart induced PH
Patients with precapillary pulmonary hypertension scheduled for right heart catheterization
Patients with established diagnosis of WHO-1-4 groups of PH undergoing right heart catheterization. This group will serve as a control.
Intervention: To discern micro-RNA specific for right and left heart induced PH
Outcomes
Primary Outcomes
Biomarker analysis
Time Frame: From baseline through one year
observation of tissue anomalies in target patients