For Healthcare Professionals

Prognostic Value of Myocardial Fibrosis in Severe Aortic Valve Stenosis

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


  1. Severe aortic stenosis (aortic valve area <1.0cm2 or aortic valve area index <0.6 cm2/m2
  2. Age ≥18 years.
  3. Signed informed patient consent form.

EXCLUSION CRITERIA

Exclusion Criteria:


  1. Severe valvular disease other than AS.
  2. Significant coronary heart disease requiring revascularisation.
  3. History of myocardial infarction.
  4. Previous cardiac surgery.
  5. Severe renal impairment eGFR <30ml/min/1.73m2.
  6. Any absolute contraindication to CMR.
  7. Inherited or acquired cardiomyopathy.
  8. Other medical conditions that limits life expectancy or precludes SAVR or TAVI.
  9. Pregnant or nursing women
  10. Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study or to follow the protocol
  11. Patients in permanent atrial fibrillation.
  12. Significant chronic obstructive pulmonary disease (FEV1 <70% of predicted value)
  13. Patient with implanted devices (pacemaker, ICD)

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Aortic Stenosis, Calcific

Age (in years)

18+

Participants needed

110

Est. Completion Date

Aug 31, 2024

Treatment type

Observational


Sponsor

Vilnius University

ClinicalTrials.gov identifier

NCT03585933

Study number

1014

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