Pulmonary Vascular Hemodynamics Before and After Mitral Valve Procedures

Pulmonary Hypertension Clinical Trial

Official title:

Pulmonary Vascular Hemodynamics Before and After Mitral Valve Procedures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04947384
• Other study ID #: IRB-300006686
• Status: Recruiting
• Start date: December 21, 2021
• Est. completion date: January 20, 2025

Study information

• Verified date: February 2024
• Source: University of Alabama at Birmingham
• Contact: Kera Marshall
• Phone: 205-934-4042
• Email: keramarshall[@]uabmc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: January 20, 2025
• Est. primary completion date: August 20, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

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.

Locations

Country	Name	City	State
United States	The University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarker analysis	observation of tissue anomalies in target patients	From baseline through one year