Aortic valve stenosis MedDRA version: 20.0 Level: PT Classification code 10002918 Term: Aortic valve stenosis System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: losartan
Product Name: losartan
Product Code: C09CA01
Pharmaceutical Form: Tablet
INN or Proposed INN: LOSARTAN
CAS Number: 114798-26-4
Concentration unit: mg milligram(s)
Concentration ty
Sponsors
Odense Universitets Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with mild-moderate AS (peak aortic jet velocity =2.5 and 20 years = 85 years 3. LV ejection fraction =50% 4. Systolic blood pressure =1 00 mmHg 5. Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 140 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 140
Exclusion criteria
Exclusion criteria: 1. More than mild aortic or mitral regurgitation or mitral stenosis 2. Current use of renin-angiotensin system medication (ACE-I, ARB or direct renin inhibitor) in patients with arterial hypertension and diabetes mellitus or arterial hypertension and chronic kidney disease stage 4-5 (estimated glomerular filtration rate 5.5 mmol/L) 5. Hepatic failure, cirrhosis, hepatitis or history of hepatic impairment 6. Newly diagnosed (<2 months) or poorly controlled diabetes 7. Pre-existing obstructive coronary artery disease with CCS III-IV angina or recent myocardial infarction (<3 months) 8. Pregnant or lactating women. Fertile women without highly effective birth control method. Patients unable to read, understand or sign research consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 3.1 Primary objectives 1.In a consecutive population of patients with mild-moderate AS to compare a.the rate of progression of peak aortic velocity (m/s) assessed by echocardiography b.the rate of progression of aortic valve calcification (AU) assessed by non-contrast CT after 24 months treatment with losartan compared with placebo. ;Secondary Objective: 3.2 Secondary objectives 1.In a consecutive population of patients with mild-moderate AS to compare a.LV geometry and mass (relative wall-thickness, LV mass index) assessed by echocardiography and magnetic resonance imaging. b.Diastolic function assessed by echocardiography c.Systolic function (LV ejection fraction, global longitudinal strain) assessed by echocardiography c.Markers of LV filling pressures (E/e’, NT-proBNP) after 24 months treatment with losartan compared with placebo treatment. ;Primary end point(s): a.the rate of progression of peak aortic velocity (m/s) assessed by echocardiography b.the rate of progression of aortic valve calcification (AU) assessed by non-contrast CT ;Timepoint(s) of evaluation of this end point: after 24 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): a. LV geometry and mass (relative wall-thickness, LV mass index) assessed by echocardiography and magnetic resonance imaging. b. Diastolic function assessed by echocardiography c. Systolic function (LV ejection fraction, global longitudinal strain) assessed by echocardiography c. Markers of LV filling pressures (E/e’, NT-proBNP) ;Timepoint(s) of evaluation of this end point: after 24 month | — |
Countries
Canada, Denmark
Contacts
Public ContactJordi Dahl
Odense University Hospital
Outcome results
None listed