Pulmonary Vascular Hemodynamics Before and After Mitral Valve Procedures

Recruiting

• Conditions: Pulmonary Hypertension
• Interventions: Diagnostic Test: To discern micro-RNA specific for right and left heart induced PH

• Registration Number: NCT04947384
• Lead Sponsor: University of Alabama at Birmingham

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-05-18
• Study First Submitted QC: 2021-06-23
• Study First Posted: 2021-07-01
• Study Start: 2021-12-21
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-27
• Last Update Posted: 2024-08-28
• Primary Completion: 2025-08-20
• Study Completion: 2025-10-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• >= 18 years/old

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients undergoing mitral valve interventions without pulmonary hypertension	To discern micro-RNA specific for right and left heart induced PH	Patients with no PH undergoing open and interventional mitral valve procedures. This group will serve as a control.
Patients with moderate mitral valve disease, undergoing interventions	To discern micro-RNA specific for right and left heart induced PH	Patients with established WHO-2 diagnosis of PH undergoing open and interventional mitral valve procedures.
Patients with precapillary pulmonary hypertension scheduled for right heart catheterization	To discern micro-RNA specific for right and left heart induced PH	Patients with established diagnosis of WHO-1-4 groups of PH undergoing right heart catheterization. This group will serve as a control.

Primary Outcome Measures

Name	Time	Method
Biomarker analysis	From baseline through one year	observation of tissue anomalies in target patients

Trial Locations

Locations (1)

The University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States