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

Aortic Valve Stenosis Clinical Trial

— FIBROTIC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05404100
• Other study ID #: H-20029458
• Status: Recruiting
• Start date: April 1, 2021
• Est. completion date: April 1, 2024

Study information

• Verified date: November 2023
• Source: Rigshospitalet, Denmark
• Contact: Katrine A Myhr, MD
• Phone: +4571120280
• Email: katrinemyhr[@]outlook.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Replacement
• Aortic Valve Stenosis
• Cardiac Magnetic Resonance
• Constriction, Pathologic
• Fibrosis
• Myocardial Fibrosis

Intervention

Procedure:
• Aortic valve replacement
SAVR or TAVR

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen O

Sponsors (4)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Danish Cardiovascular Academy (DCA), Eva og Henry Frænkels Mindefond, Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in T1 values from baseline to follow-up		Through study completion, an average of 1 year
Secondary	New York Heart Association (NYHA) Classification		Through study completion, an average of 1 year
Secondary	Type of AVR	SAVR or TAVR	Through study completion, an average of 1 year
Secondary	Native valve	Bicuspid or tricuspid aortic valve	Through study completion, an average of 1 year
Secondary	Left ventricular volumes	By cardiac magnetic resonance	Through study completion, an average of 1 year
Secondary	Left ventricular mass	By cardiac magnetic resonance	Through study completion, an average of 1 year
Secondary	Left ventricular strain	By cardiac magnetic resonance and echocardiography	Through study completion, an average of 1 year
Secondary	Late gadolinium enhancement	By cardiac magnetic resonance	Through study completion, an average of 1 year
Secondary	Extracellular volume	By cardiac magnetic resonance	Through study completion, an average of 1 year
Secondary	Left ventricular ejection fraction	By cardiac magnetic resonance and echocardiography	Through study completion, an average of 1 year
Secondary	Left atrial size	By cardiac magnetic resonance and echocardiography	Through study completion, an average of 1 year
Secondary	e' velocity	By echocardiography	Through study completion, an average of 1 year
Secondary	E/e' ratio	By echocardiography	Through study completion, an average of 1 year
Secondary	Tricuspid regurgitation velocity	By echocardiography	Through study completion, an average of 1 year
Secondary	Concentration of NT-Pro-BNP		Through study completion, an average of 1 year
Secondary	Concentration of Troponin T		Through study completion, an average of 1 year