Assessing microvascular function in patients receiving heart valve implants for severe aortic stenosis
Microvascular Function in Patients Undergoing Transcatheter Aortic Valve Implant (TAVI) for Severe Symptomatic Aortic Stenosis: Association With Myocardial Fibrosis
This study is testing how heart valve implants for severe aortic stenosis affect small blood vessel function in patients to see if it relates to heart problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | IRCCS San Raffaele Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT05326126 on ClinicalTrials.gov |
What this trial studies
This study investigates the microvascular function in patients undergoing Transcatheter Aortic Valve Implantation (TAVI) for severe symptomatic aortic stenosis, focusing on its association with myocardial fibrosis. The research aims to understand how chronic left ventricular afterload leads to myocardial changes that can result in heart failure and increased cardiac mortality. By examining these relationships, the study seeks to provide insights into the underlying mechanisms of cardiac decompensation in affected patients.
Who should consider this trial
Good fit: Ideal candidates are patients over 18 years old who are referred for TAVI due to severe symptomatic aortic stenosis.
Not a fit: Patients with significant chronic kidney disease, known coronary artery stenosis, or other serious comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve understanding of cardiac function and lead to better management strategies for patients with severe aortic stenosis.
How similar studies have performed: While the specific association of microvascular function and myocardial fibrosis in TAVI patients is less explored, related studies on myocardial perfusion and heart failure have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: • All patients referred to IRCCS Ospedale San Raffaele who are candidates to receive a TAVI implant for severe, symptomatic aortic stenosis under current appropriateness criteria and clinical practice guidelines will be considered eligible to take part in the study Exclusion Criteria: * Age \<18 years * Inability to express informed consent to take part in the present study. * Pregnancy or lactation * Pre-existing known disease determining a prognosis quo ad vitam shorter than the follow up of the present study * Significant chronic kidney disease (estimated glomerular filtration rate \<30 ml/min) * Known significant epicardial coronary artery stenosis * Known contraindication to adenosine administration: * Known allergic reactions * Second or third degree atrioventricular block before the procedure (in absence of a functional permanent pacemaker) * Long QT syndrome * Unstable angina * Severe hypotension * Acutely decompensated heart failure * Chronic obstructive pulmonary disease with bronchospasm * Concomitant use of dypiridamole
Where this trial is running
Milan
- IRCCS San Raffaele — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Matteo montorfano, MD — IRCCS San Raffaele
- Study coordinator: Marco Ancona, MD
- Email: ancona.marco@hsr.it
- Phone: +39/26437331
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.