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 range

50 Years – 90 Years

Sex

ALL

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2016-01

View on ClinicalTrials.gov More Aortic Stenosis trials