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

Recruiting

• Conditions: Aortic Valve Stenosis; Cardiac Magnetic Resonance; T1 Mapping; Aortic Valve Replacement; Myocardial Fibrosis
• Interventions: Procedure: Aortic valve replacement

• Registration Number: NCT05404100
• Lead Sponsor: Rigshospitalet, Denmark

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-01
• Study First Submitted: 2022-05-25
• Study First Submitted QC: 2022-05-30
• Study First Posted: 2022-06-03
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18
• Primary Completion: 2024-04-01
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Severe aortic valve stenosis	Aortic valve replacement	Patients with severe AS planned to undergo AVR, either as surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR).

Primary Outcome Measures

Name	Time	Method
Change in T1 values from baseline to follow-up	Through study completion, an average of 1 year

Secondary Outcome Measures

Name	Time	Method
Extracellular volume	Through study completion, an average of 1 year	By cardiac magnetic resonance
E/e' ratio	Through study completion, an average of 1 year	By echocardiography
Concentration of Troponin T	Through study completion, an average of 1 year
Concentration of NT-Pro-BNP	Through study completion, an average of 1 year
Left ventricular strain	Through study completion, an average of 1 year	By cardiac magnetic resonance and echocardiography
Left ventricular ejection fraction	Through study completion, an average of 1 year	By cardiac magnetic resonance and echocardiography
New York Heart Association (NYHA) Classification	Through study completion, an average of 1 year
Left ventricular mass	Through study completion, an average of 1 year	By cardiac magnetic resonance
Late gadolinium enhancement	Through study completion, an average of 1 year	By cardiac magnetic resonance
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 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

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen O, Denmark