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

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

Study Overview

• Status: Completed
• Conditions: Myocardial Fibrosis; Aortic Valve Stenosis; Cardiac Magnetic Resonance; Aortic Valve Replacement; T1 Mapping
• Intervention / Treatment: Procedure: Aortic valve replacement

• Study Type: Observational
• Enrollment (Actual): 86

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen O, Denmark, 2100
    • Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients are recruited from Righospitalet, Denmark, when referred to AVR.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Severe aortic valve stenosis; Patients with severe AS, either symptomatic patients planned to undergo AVR as surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR), or asymptomatic patients managed with clinical surveillance.	Procedure: Aortic valve replacement; SAVR or TAVR

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
New York Heart Association (NYHA) Classification		Through study completion, an average of 1 year
Type of AVR	SAVR or TAVR	Through study completion, an average of 1 year
Native valve	Bicuspid or tricuspid aortic valve	Through study completion, an average of 1 year
Left ventricular volumes	By cardiac magnetic resonance	Through study completion, an average of 1 year
Left ventricular mass	By cardiac magnetic resonance	Through study completion, an average of 1 year
Left ventricular strain	By cardiac magnetic resonance and echocardiography	Through study completion, an average of 1 year
Late gadolinium enhancement	By cardiac magnetic resonance	Through study completion, an average of 1 year
Extracellular volume	By cardiac magnetic resonance	Through study completion, an average of 1 year
Left ventricular ejection fraction	By cardiac magnetic resonance and echocardiography	Through study completion, an average of 1 year
Left atrial size	By cardiac magnetic resonance and echocardiography	Through study completion, an average of 1 year
e' velocity	By echocardiography	Through study completion, an average of 1 year
E/e' ratio	By echocardiography	Through study completion, an average of 1 year
Tricuspid regurgitation velocity	By echocardiography	Through study completion, an average of 1 year
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

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation; Danish Cardiovascular Academy (DCA); Eva og Henry Frænkels Mindefond

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): September 8, 2025
• Study Completion (Actual): September 8, 2025

Study Registration Dates

• First Submitted: May 25, 2022
• First Submitted That Met QC Criteria: May 30, 2022
• First Posted (Actual): June 3, 2022

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Aortic Valve Replacement; Aortic Valve Stenosis; Cardiac Magnetic Resonance; Myocardial Fibrosis; T1 mapping
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Surgical Procedures, Operative; Cardiovascular Surgical Procedures; Cardiac Surgical Procedures; Thoracic Surgical Procedures; Prosthesis Implantation; Heart Valve Prosthesis Implantation; Transcatheter Aortic Valve Replacement
• Other Study ID Numbers: H-20029458

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data can be provided upon request
• IPD Sharing Time Frame: From study end
• IPD Sharing Access Criteria: Researchers who provide a methodological sound proposal

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No