Examining heart function before and after mitral valve procedures in patients with pulmonary hypertension
Pulmonary Vascular Hemodynamics Before and After Mitral Valve Procedures
This study is testing how heart function changes before and after mitral valve surgery in patients with pulmonary hypertension to see if it can help identify signs of ongoing issues after the procedure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT04947384 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the changes in pulmonary vascular and right ventricular remodeling in patients diagnosed with pulmonary hypertension (PH) undergoing mitral valve procedures. It will enroll three groups: patients with established WHO-2 PH, patients without PH, and patients with varying degrees of PH undergoing right heart catheterization. Blood samples and echocardiograms will be collected at three key time points: before the procedure, after the procedure, and at discharge. The goal is to identify markers that could help in the early detection and prediction of residual pulmonary hypertension post-surgery.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a WHO-2 diagnosis of pulmonary hypertension scheduled for mitral valve procedures.
Not a fit: Patients with severe heart conditions, such as low ejection fraction or severe tricuspid valve regurgitation, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection and management of residual pulmonary hypertension in patients undergoing mitral valve procedures.
How similar studies have performed: While this approach is novel in its specific focus on mitral valve procedures and pulmonary hypertension, similar studies have shown promise in understanding heart function and pulmonary vascular changes.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Birmingham, Alabama
- The University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Principal investigator: Ahmed Zaky, MD — The University of Alabama at Birmingham
- Study coordinator: Kera Marshall
- Email: keramarshall@uabmc.edu
- Phone: 205-934-4042
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.