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Pulmonary Vascular Hemodynamics Before and After Mitral Valve Procedures

Pulmonary Vascular Hemodynamics Before and After Mitral Valve Procedures

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04947384
Enrollment
0
Registered
2021-07-01
Start date
2021-12-21
Completion date
2026-01-20
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Hypertension

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.

Interventions

DIAGNOSTIC_TESTTo 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.

Sponsors

University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Biomarker analysisFrom baseline through one yearobservation of tissue anomalies in target patients

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAhmed Zaky, MD

The University of Alabama at Birmingham

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026