Identification of Parameters in rapId-proGression Subgroup Patients With Moderate Aortic Stenosis (NCT01575249) | Clinical Trial Compass
UnknownNot Applicable
Identification of Parameters in rapId-proGression Subgroup Patients With Moderate Aortic Stenosis
Romania200 participantsStarted 2012-07
Plain-language summary
The investigators aim to identify all clinical, biological, echo and imagistic parameters that predispose to increased progression rates in a prospective observational trial which will include ONLY patients with moderate AS, with the complete cardiological investigational tools provided in 2012. Once those parameters are found, medical and interventional treatment could be implemented to decrease the mortality rates.
Who can participate
Age range50 Years – 90 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* age 21 years;
* native aortic valve leaflet thickening with reduced systolic opening on two-dimensional echocardiography and an aortic jet velocity at rest between 2.8 and 3.1 m/s or a valve area calculated by the continuity equation of 1.7 to 1.5 cm2, evaluated at a heart rate between 60 and 90/ minute and at a systolic arterial pressure of 120-140mmHg at baseline;
* LVEF \> 55% (calculated by modified Simpson formula).
Exclusion Criteria:
* positive stress test (symptoms including dyspnoea, angina, syncope, ECG pathological changes, WMA);
* positive pulmonary disease (spirometry);
* heart failure;
* LVEF \< 55%;
* moderate/severe aortic or mitral regurgitation or mitral stenosis, subvalvular or supravalvular AS, dynamic subaortic obstruction;
* CAD (history of MI or coronary artery stenosis on coronary angiography);
* active endocarditis;
* rhythm other than sinus rhythm;
* severe uncontrolled risk factors for CAD:
* uncontrolled DM,
* uncontrolled hypertension (SBP \> 180mmHg),
* refuse to discontinue smoking,
* persistent hypercholesterolemia under treatment (total cholesterol \> 240mg/dl);
* glomerular filtration rate \< 30% or patient requiring dialysis;
* patient refusal; survival expectancy \< 2 years;
* inability to perform physical exercise;
* suboptimal echo window;
* different types of echo machines.
What they're measuring
1
occurrence of major adverse cardiac events (MACE) defined by the followings: death, aortic valve replacement (AVR) and myocardial infarction (MI).
Timeframe: 3 years
Trial details
NCT IDNCT01575249
SponsorCarol Davila University of Medicine and Pharmacy