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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
View:

• Age ≥ 18 years

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

Locations
Other Locations
Denmark
Rigshospitalet
RECRUITING
Copenhagen O
Contact Information
Primary
Katrine A Myhr, MD
katrinemyhr@outlook.dk
+4571120280
Backup
Redi Pecini, MD, PhD
redi.pecini@regionh.dk
Time Frame
Start Date: 2021-04-01
Estimated Completion Date: 2024-04-01
Participants
Target number of participants: 60
Treatments
Severe aortic valve stenosis
Patients with severe AS planned to undergo AVR, either as surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR).
Sponsors
Collaborators: Danish Cardiovascular Academy (DCA), Eva og Henry Frænkels Mindefond, Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation
Leads: Rigshospitalet, Denmark

This content was sourced from clinicaltrials.gov