FIBROTIC: Effects of Aortic Valve Replacement on Myocardial T1 Values in Severe Aortic Valve Stenosis

Sponsor

Rigshospitalet, Denmark (Other)

Overall Status

Recruiting

CT.gov ID

NCT05404100

Collaborator

Danish Cardiovascular Academy (DCA) (Other), Eva og Henry Frænkels Mindefond (Other), Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation (Other)

Enrollment

Location

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Stenosis Aortic Valve Replacement Myocardial Fibrosis Cardiac Magnetic Resonance T1 Mapping	Procedure: Aortic valve replacement

Study Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Effects of Aortic Valve Replacement on Myocardial T1 Values in Severe Aortic Valve Stenosis

Actual Study Start Date :

Apr 1, 2021

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Severe aortic valve stenosis Patients with severe AS planned to undergo AVR, either as surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR).	Procedure: Aortic valve replacement SAVR or TAVR

Arm

Intervention/Treatment

Severe aortic valve stenosis

Patients with severe AS planned to undergo AVR, either as surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR).

Procedure: Aortic valve replacement

SAVR or TAVR

Outcome Measures

Primary Outcome Measures

Change in T1 values from baseline to follow-up [Through study completion, an average of 1 year]

Secondary Outcome Measures

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
E/e' ratio [Through study completion, an average of 1 year]
By echocardiography
Tricuspid regurgitation velocity [Through study completion, an average of 1 year]
By echocardiography
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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