Aortic Valve Replacement, Aortic Valve Stenosis, Cardiac Magnetic Resonance, Myocardial Fibrosis, T1 Mapping
Conditions
Keywords
Aortic Valve Stenosis, Aortic Valve Replacement, Myocardial Fibrosis, Cardiac Magnetic Resonance, T1 mapping
Brief summary
Background: Severe aortic valve stenosis (AS) is the commonest valve disease. Aortic valve replacement (AVR) is primarily indicated when symptoms occur and/or when there is a drop in left ventricular ejection fraction. However, irreversible myocardial damage, such as replacement fibrosis, leads to increased morbidity and mortality despite treatment. Improved patient selection and timely treatment is thus warranted. T1 mapping, a non-invasive method to quantify myocardial fibrosis by cardiac magnetic resonance (CMR), could be a marker to guide treatment. Aims: To investigate the change of myocardial fibrosis\* in AS patients following AVR and if these changes are associated with disease and/or procedural characteristics. Methods: This is an observational clinical trial. Approximately 60 patients with severe AS planned to undergo AVR (either surgical or transcatheter) at Rigshospitalet, Denmark will be included. Participants will undergo CMR before surgery and at a 1-year follow-up. Other assessments include clinical evaluation and blood sampling. The primary end-point is change in T1 values after AVR. Hypotheses and perspectives: The investigators hypothesize that (1) myocardial fibrosis\* will regress in patients undergoing AVR as a group, (2) the degree of myocardial fibrosis is positively correlated with the degree of symptoms, (3) the regression of myocardial fibrosis is greater in patients undergoing TAVR compared to SAVR, and (4) the regression of myocardial fibrosis is greater in patients with tricuspid aortic stenosis compared to bicuspid aortic stenosis. Ultimately, T1 mapping is a potential marker for improved patient selection for the timing of AVR. \* Estimated by T1 mapping
Interventions
PROCEDUREAortic valve replacement
SAVR or TAVR
Sponsors
Rigshospitalet, Denmark
Danish Cardiovascular Academy (DCA)
Eva og Henry Frænkels Mindefond
Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Age ≥ 18 years * Severe aortic valve stenosis (Vmax \> 4 m/s and/or mean gradient \>40 mmHg)
Exclusion criteria
* Reduced left ventricular ejection fraction (\<50%) * More than mild left-sided valvular insufficiency * Previous or planned primary coronary intervention (PCI) or coronary artery by-pass grafting (CABG) * Persistent atrial fibrillation * Contraindications for CMR (pregnancy, severe claustrophobia, magnetic metallic implants) * Pacemaker/ICD
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in T1 values from baseline to follow-up | Through study completion, an average of 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of NT-Pro-BNP | Through study completion, an average of 1 year | — |
| Concentration of Troponin T | Through study completion, an average of 1 year | — |
| New York Heart Association (NYHA) Classification | Through study completion, an average of 1 year | — |
| Type of AVR | Through study completion, an average of 1 year | SAVR or TAVR |
| Native valve | Through study completion, an average of 1 year | Bicuspid or tricuspid aortic valve |
| Left ventricular volumes | Through study completion, an average of 1 year | By cardiac magnetic resonance |
| Left ventricular mass | Through study completion, an average of 1 year | By cardiac magnetic resonance |
| Left ventricular strain | Through study completion, an average of 1 year | By cardiac magnetic resonance and echocardiography |
| Late gadolinium enhancement | Through study completion, an average of 1 year | By cardiac magnetic resonance |
| Extracellular volume | Through study completion, an average of 1 year | By cardiac magnetic resonance |
| Left ventricular ejection fraction | Through study completion, an average of 1 year | By cardiac magnetic resonance and echocardiography |
| Left atrial size | Through study completion, an average of 1 year | By cardiac magnetic resonance and echocardiography |
| e' velocity | Through study completion, an average of 1 year | By echocardiography |
| Tricuspid regurgitation velocity | Through study completion, an average of 1 year | By echocardiography |
| E/e' ratio | Through study completion, an average of 1 year | By echocardiography |
Countries
Denmark
Outcome results
None listed