Prognostic Value of Myocardial Fibrosis in Severe Aortic Valve Stenosis (FIB-AS)
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|ClinicalTrials.gov Identifier: NCT03585933|
Recruitment Status : Not yet recruiting
First Posted : July 13, 2018
Last Update Posted : July 20, 2018
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.
|Condition or disease||Intervention/treatment|
|Aortic Stenosis, Calcific||Diagnostic Test: Cardiac magnetic resonance imaging|
AS is the most common valvular heart condition in the Western world. In response to increased afterload imposed by AS adaptive left ventricular (LV) remodelling occurs which in a course of a disease transitions from LV hypertrophy to maladaptive changes in the myocardium leading to cardiac decompensation and symptoms development. This transition is predominantly driven by myocardial fibrosis and myocyte cell death. Increasing evidence have demonstrated that presence of myocardial fibrosis, detected by cardiovascular magnetic resonance (CMR), could serve as an early marker of LV decompensation and predict adverse outcomes in patients with aortic stenosis. Currently, the indications for valvular replacement are based on the stenosis severity evaluated by echocardiography and the presence of symptoms.
The objective of the project is to identify parameters of non-invasive imaging modalities (two-dimensional echocardiography with an extended myocardial deformation analysis, 1.5 T CMR with T1 parametric map and late gadolinium enhancement (LGE) predictive of cardiac decompensation and to evaluate the prognostic significance of myocardial fibrotic changes in patients with severe degenerative AS. In patients with suspicion of cardiac amyloidosis, 99mTc-3,3-diphosphono-1,2-propanodicarboxylic acid (DPD) scintigraphy will be performed.
Study design: a prospective, open, case-driven, multicentre study (Lithuania, Denmark).
Investigators will assess LV structural and functional alterations before and 12 months after aortic valve intervention. Cardiac imaging data will be aligned with histopathological data from myocardial tissue samples collected at the time of aortic valve replacement in SAVR group. In patients with suspicion of cardiac amyloidosis, DPD scintigraphy and further evaluation regarding amyloidosis will be performed.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Prognostic Value of Myocardial Fibrosis in Severe Aortic Valve Stenosis|
|Estimated Study Start Date :||September 2018|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||September 2021|
- 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 amyloidosisOther Names:
- Intra-operative myocardial biopsy
- DPD scintigraphy
- Cardiovascular mortality [ Time Frame: 2 years ]Cardiovascular death
- Major adverse cardiovascular events [ Time Frame: 2 years ]Acute myocardial infarction, stroke, heart failure requiring hospitalisation
- Short term mortality [ Time Frame: 30 days ]Intrahospital or 30 days mortality
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03585933
|Contact: Sigita Glaveckaite, PhDfirstname.lastname@example.org|
|Contact: Giedre Balciunaite, MDemail@example.com|
|Aalborg University Hospital||Not yet recruiting|
|Contact: Tomas Zaremba, PhD +37068095463 firstname.lastname@example.org|
|Vilnius University Hospital Santaros clinics||Not yet recruiting|
|Vilnius, Lithuania, 08416|
|Contact: Sigita Glaveckaite, PhD +37068240937 email@example.com|
|Contact: Giedre Balciunaite, MD +37069823346 firstname.lastname@example.org|
|Principal Investigator:||Peter Sogaard, Prof.||Aalborg University|