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Completed

NCT Number: NCT05404100

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

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

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Aortic Valve Replacement Cardiac Magnetic Resonance Cardiovascular Diseases Heart Diseases Heart Valve Diseases Myocardial Fibrosis T1 Mapping Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rigshospitalet

Copenhagen O, 2100, Denmark

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aortic valve replacement

Procedure

SAVR or TAVR

Primary outcomes

  1. Change in T1 values from baseline to follow-up

    Time frame: Through study completion, an average of 1 year

Secondary outcomes

  1. New York Heart Association (NYHA) Classification

    Time frame: Through study completion, an average of 1 year

  2. Type of AVR

    Time frame: Through study completion, an average of 1 year

    SAVR or TAVR

  3. Native valve

    Time frame: Through study completion, an average of 1 year

    Bicuspid or tricuspid aortic valve

  4. Left ventricular volumes

    Time frame: Through study completion, an average of 1 year

    By cardiac magnetic resonance

  5. Left ventricular mass

    Time frame: Through study completion, an average of 1 year

    By cardiac magnetic resonance

  6. Left ventricular strain

    Time frame: Through study completion, an average of 1 year

    By cardiac magnetic resonance and echocardiography

  7. Late gadolinium enhancement

    Time frame: Through study completion, an average of 1 year

    By cardiac magnetic resonance

  8. Extracellular volume

    Time frame: Through study completion, an average of 1 year

    By cardiac magnetic resonance

  9. Left ventricular ejection fraction

    Time frame: Through study completion, an average of 1 year

    By cardiac magnetic resonance and echocardiography

  10. Left atrial size

    Time frame: Through study completion, an average of 1 year

    By cardiac magnetic resonance and echocardiography

  11. e' velocity

    Time frame: Through study completion, an average of 1 year

    By echocardiography

  12. E/e' ratio

    Time frame: Through study completion, an average of 1 year

    By echocardiography

  13. Tricuspid regurgitation velocity

    Time frame: Through study completion, an average of 1 year

    By echocardiography

  14. Concentration of NT-Pro-BNP

    Time frame: Through study completion, an average of 1 year

  15. Concentration of Troponin T

    Time frame: Through study completion, an average of 1 year

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Danish Cardiovascular Academy (DCA)
  • Eva og Henry Frænkels Mindefond
  • Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation

Registry information

Acronym: FIBROTIC

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jun 3, 2022
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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