NCT04947384

Pulmonary Vascular Hemodynamics Before and After Mitral Valve Procedures

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Hypertension

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	To discern micro-RNA specific for right and left heart induced PH	While undergoing other procedures, the investigators will be collecting a total of three 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.

Timeline

• Start date: 2021-12-21
• Primary completion: 2025-12-20
• Completion: 2026-01-20
• First posted: 2021-07-01
• Last updated: 2026-01-27

Locations

1 site across 1 country: United States