Pulmonary Vascular Hemodynamics Before and After Mitral Valve Procedures

NCT04947384 | Withdrawn

• 2 other identifiers: IRB-300006686UAB
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• Biomarker analysis

  observation of tissue anomalies in target patients

  From baseline through one year

Study Arms (3)

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

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

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

Interventions

To discern micro-RNA specific for right and left heart induced PH DIAGNOSTIC_TEST

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 moderate mitral valve disease, undergoing interventions; Patients with precapillary pulmonary hypertension scheduled for right heart catheterization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• \>= 18 years/old

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

The University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ahmed Zaky, MD

  The University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: July 1, 2021
• Study Start: December 21, 2021
• Primary Completion: December 20, 2025
• Study Completion: January 20, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

US (1)