Comparing early aortic valve surgery to watchful waiting for severe asymptomatic aortic regurgitation
Early Aortic Valve Surgery Versus Watchful Waiting Strategy in Severe Asymptomatic Aortic Regurgitation
This study tests whether early surgery or just monitoring is better for people with severe aortic regurgitation who don't have symptoms, to see which option helps their heart health more.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 217 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Na Homolce Hospital Academic / other |
| Locations | 8 sites (Aalst and 7 other locations) |
| Trial ID | NCT05438862 on ClinicalTrials.gov |
What this trial studies
This study evaluates the timing of surgical intervention in patients with severe asymptomatic aortic regurgitation. It compares early surgical treatment to a conventional watchful waiting strategy based on cardiac magnetic resonance assessments. The goal is to determine the optimal approach to prevent heart failure and improve outcomes in this patient population. Participants will be monitored for changes in left ventricular function and overall health status.
Who should consider this trial
Good fit: Ideal candidates are asymptomatic patients with chronic severe aortic regurgitation and preserved left ventricular function.
Not a fit: Patients with significant concomitant valve disease, complex congenital heart disease, or those who are symptomatic may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for patients with severe asymptomatic aortic regurgitation, potentially preventing heart failure.
How similar studies have performed: Other studies have explored surgical interventions for aortic regurgitation, but this specific comparison of early surgery versus watchful waiting is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Chronic asymptomatic aortic regurgitation grade 3 (moderate to severe) and grade 4 (severe) * No indication for the surgical treatment at the time of enrolment * LV ejection fraction \>50% * Absence of more than mild-to-moderate concomitant valve disease or complex congenital heart disease Exclusion Criteria: * Age \<18 years * Clearance Creatinine \<30 mL/min * Contraindication for magnetic resonance (implanted active device, ferromagnetic implant incompatible with magnetic resonance scanner, cerebral aneurysm clip, metallic fragment in the eye or near sensitive tissue) * Pregnancy * Permanent atrial fibrillation.
Where this trial is running
Aalst and 7 other locations
- Cardiovascular Center OLV Clinic Aalst — Aalst, Belgium (Recruiting)
- International Clinical Research Center, St. Anne´s University Hospital Brno — Brno, Czechia (Active_not_recruiting)
- Center of Cardiovascular and Transplant Surgery — Brno, Czechia (Recruiting)
- University Hospital Hradec Králové — Hradec Králové, Czechia (Recruiting)
- 2nd Department of Internal Cardiovascular Medicine, First Faculty of Medicine, Charles University and General University Hospital in Prague — Prague, Czechia (Recruiting)
- Na Homolce Hospital — Prague, Czechia (Recruiting)
- Nemocnice AGEL Třinec-Podlesí — Třinec, Czechia (Recruiting)
- University Clinical Center of Serbia — Belgrade, Serbia (Recruiting)
Study contacts
- Principal investigator: Radka Kočková, MD, PhD — Na Homolce Hospital
- Study coordinator: Radka Kočková, MD,PhD
- Email: radka.kockova@centrum.cz
- Phone: +420606483586
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.