Clinical trial NCT05404100: Effects of Aortic Valve Replacement on Myocardial T1 Values in Severe Aortic Valve Stenosis
Official title: Effects of Aortic Valve Replacement on Myocardial T1 Values in Severe Aortic Valve Stenosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Valve Stenosis
Aortic Valve Replacement
Myocardial Fibrosis
Cardiac Magnetic Resonance
T1 Mapping
Keywords: Aortic Valve Stenosis
Aortic Valve Replacement
Myocardial Fibrosis
Cardiac Magnetic Resonance
T1 mapping
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Danish Cardiovascular Academy (DCA)
name: Eva og Henry Frænkels Mindefond
name: Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation
First posted: 2022-06-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients are recruited from Righospitalet, Denmark, when referred to AVR.

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


Eligibility criteria: 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

Primary outcomes:
measure: Change in T1 values from baseline to follow-up
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: New York Heart Association (NYHA) Classification
timeFrame: Through study completion, an average of 1 year
measure: Type of AVR
timeFrame: Through study completion, an average of 1 year
measure: Native valve
timeFrame: Through study completion, an average of 1 year
measure: Left ventricular volumes
timeFrame: Through study completion, an average of 1 year
measure: Left ventricular mass
timeFrame: Through study completion, an average of 1 year
measure: Left ventricular strain
timeFrame: Through study completion, an average of 1 year
measure: Late gadolinium enhancement
timeFrame: Through study completion, an average of 1 year
measure: Extracellular volume
timeFrame: Through study completion, an average of 1 year
measure: Left ventricular ejection fraction
timeFrame: Through study completion, an average of 1 year
measure: Left atrial size
timeFrame: Through study completion, an average of 1 year
measure: e' velocity
timeFrame: Through study completion, an average of 1 year
measure: E/e' ratio
timeFrame: Through study completion, an average of 1 year
measure: Tricuspid regurgitation velocity
timeFrame: Through study completion, an average of 1 year
measure: Concentration of NT-Pro-BNP
timeFrame: Through study completion, an average of 1 year
measure: Concentration of Troponin T
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Copenhagen O
country: Denmark
facility: Rigshospitalet
Study officials:
References: