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

NCT05404100 | Completed

• 1 other identifier: H-20029458
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

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

Conditions

Myocardial Fibrosis; Cardiac Magnetic Resonance; T1 Mapping; Aortic Valve Stenosis; Aortic Valve Replacement

Keywords

Aortic Valve Stenosis; Aortic Valve Replacement; Myocardial Fibrosis; Cardiac Magnetic Resonance; T1 mapping

Outcome Measures

Primary Outcomes (1)

• Change in T1 values from baseline to follow-up

  Through study completion, an average of 1 year

Secondary Outcomes (15)

• 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

• Native valve

  Through study completion, an average of 1 year

• Left ventricular volumes

  Through study completion, an average of 1 year

• Left ventricular mass

  Through study completion, an average of 1 year

Study Arms (1)

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

Interventions

Aortic valve replacement PROCEDURE

SAVR or TAVR

Severe aortic valve stenosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Age ≥ 18 years
• Severe aortic valve stenosis (Vmax \> 4 m/s and/or mean gradient \>40 mmHg)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Rigshospitalet

Copenhagen O, 2100, Denmark

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principtal Investigator

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: June 3, 2022
• Study Start: April 1, 2021
• Primary Completion: September 8, 2025
• Study Completion: September 8, 2025
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: From study end
• Access Criteria: Researchers who provide a methodological sound proposal

Locations

DK (1)