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Prognostic Value of Myocardial Fibrosis in Severe Aortic Valve Stenosis

NCT03585933 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 110

Last updated 2022-10-18

No results posted yet for this study

Summary

Degenerative aortic valve stenosis (AS) is the most common valve heart disease in the developed Western countries. The hemodynamic progression of AS occurs over time and leads to LV hypertrophy (LVH) as a compensation mechanism of the heart. Morphological changes such as increasing muscle fibre thickness, collagen volume, and interstitial fibrosis occur in AS patients. These changes result in left ventricular (LV) diastolic and systolic dysfunction and, consequently, to with AS related symptoms. When symptoms associated with AS appear, patients' prognosis is poor if surgical aortic valve replacement (SAVR) or a trans-catheter aortic valve implantation (TAVI) is not performed.

Primary hypothesis of the research: fibrotic changes in the myocardium are related to immediate (in hospital) or long-term complications (MACE and all-cause mortality) in patients with severe AS.

The goal of the study is to determine the prognostic implications of focal as well as diffuse myocardial fibrosis in patients with severe aortic valve stenosis.

Conditions

  • Aortic Stenosis, Calcific

Interventions

DIAGNOSTIC_TEST

Cardiac magnetic resonance imaging

Echocardiography: assessment of aortic stenosis severity, evaluation of LV diastolic and systolic function; CMR: chambers quantification, LGE, T1 mapping; Intraoperative myocardial tissue biopsy for patients undergoing SAVR; DPD scintigraphy: assessment of cardiac transthyretin amyloidosis

Sponsors & Collaborators

  • Vilnius University

    lead OTHER

Principal Investigators

  • Peter Sogaard, Prof. · Aalborg University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-08
Primary Completion
2024-08-31
Completion
2024-08-31

Countries

  • Denmark
  • Lithuania

Study Locations

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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 NCT03585933 on ClinicalTrials.gov