Pulmonary Vascular Hemodynamics Before and After Mitral Valve Procedures

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.

Study Overview

• Status: Withdrawn
• Conditions: Pulmonary Hypertension
• Intervention / Treatment: Diagnostic test: To discern micro-RNA specific for right and left heart induced PH

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • The University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult patients undergoing mitral valve procedures at the University of Alabama at Birmingham main hospital

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with moderate mitral valve disease, undergoing interventions; Patients with established WHO-2 diagnosis of PH undergoing open and interventional mitral valve procedures.	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.
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomarker analysis	observation of tissue anomalies in target patients	From baseline through one year

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Ahmed Zaky, MD, The University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2021
• Primary Completion (Estimated): December 20, 2025
• Study Completion (Estimated): January 20, 2026

Study Registration Dates

• First Submitted: May 18, 2021
• First Submitted That Met QC Criteria: June 23, 2021
• First Posted (Actual): July 1, 2021

Study Record Updates

• Last Update Posted (Actual): January 27, 2026
• Last Update Submitted That Met QC Criteria: January 24, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: IRB-300006686; UAB (Other Identifier: UAB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No