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

NCT05404100 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 86

Last updated 2026-03-11

No results posted yet for this study

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

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

Interventions

PROCEDURE

Aortic valve replacement

SAVR or TAVR

Sponsors & Collaborators

  • Danish Cardiovascular Academy (DCA)

    collaborator UNKNOWN

  • Eva og Henry Frænkels Mindefond

    collaborator OTHER

  • Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation

    collaborator OTHER

  • Rigshospitalet, Denmark

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2025-09-08
Completion
2025-09-08

Countries

  • Denmark

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05404100 on ClinicalTrials.gov