LOSARTAN POTASSIUM for Aortic stenosis

Inclusion criteria

• {"criterion_text":"- Patients with mild-moderate aortic stenosis (peak aortic jet velocity ≥2.5 and <4m/s)."}
• {"criterion_text":"- Age ≥ 20 ≤ 85 years"}
• {"criterion_text":"- Left ventricular ejection fraction ≥50%"}
• {"criterion_text":"- Systolic blood pressure ≥100 mmHg"}
• {"criterion_text":"- Signed informed consent"}

Exclusion criteria

• {"criterion_text":"- More than mild aortic or mitral regurgitation, or mitral stenosis"}
• {"criterion_text":"- Current use of renin-angiotensin system medication or Aliskiren in patiens with arterial hypertension and diabetes mellitus or arterial hypertension and chronic kidney disease stage 4-5 (estimated glomerular filtration rate <30 ml/min/1.73m2)"}
• {"criterion_text":"- Known allergy or intolerance to Angiotensin-receptor-blockers, poorly controlled blood pressure"}
• {"criterion_text":"- Renal dysfunction (glomerular filtration rate <30ml/min/1.73 m2) or chronic hyperkalemia (P-potassium ≥5.5 mmol/l)"}
• {"criterion_text":"- Hepatic failure, cirrhosis, hepatitis or history of hepatic impairment"}
• {"criterion_text":"- Newly diagnosed (<2 months) or poorly controlled diabetes; HbA1c >86 mmol/mol (>10%)"}
• {"criterion_text":"- Pre-existing obstructive coronary artery disease with CCS III-IV angina or recent myocardial infarction (<3 months)"}
• {"criterion_text":"- Pregnant or lactating women. Fertile women without highly effective birth control method. Patients unable to read, understand or sign research consent"}

Primary endpoints

• {"endpoint_text":"- The rate of progression of peak aortic velocity (m/s) assessed by echocardiography","definition_or_measurement_approach":"Assessed by echocardiography; measurement of peak aortic jet velocity in m/s to determine progression rate."}
• {"endpoint_text":"- The rate of progression of aortic valve calcification (AU) assessed by non-contrast computed tomography after 24 months treatment with losartan compared with placebo.","definition_or_measurement_approach":"Assessed by non-contrast computed tomography (CT) with aortic valve calcification quantified in Agatston Units (AU) after 24 months of treatment, comparing losartan to placebo."}

Secondary endpoints

• {"endpoint_text":"- Left ventricular geometry and mass (relative wall-thickness, left ventricular mass index) assessed by echocardiography and magnetic resonance imaging after 24 months treatment with losartan compared with placebo treatment.","definition_or_measurement_approach":"Assessed by echocardiography and cardiac magnetic resonance imaging after 24 months; measures include relative wall thickness and LV mass index."}
• {"endpoint_text":"- Diastolic function assessed by echocardiography","definition_or_measurement_approach":"Assessed by echocardiography using standard diastolic function parameters."}
• {"endpoint_text":"- Markers of left ventricular filling pressures (E/e’, NT-proBNP)","definition_or_measurement_approach":"Measurement of echocardiographic E/e' ratio and blood biomarker NT-proBNP to estimate LV filling pressures."}

Denmark

Earliest CTIS Part Ii Submission Date

27-01-2025

Latest Decision Or Authorization Date

30-01-2025

Processing Time Days

3

Number Of Sites

1

Number Of Participants

139

Primary sponsor

Full Name

Odense University Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Odense University Hospital","duties_or_roles":"sponsorDuties codes: 1,7,8","organisation_type":"Hospital/Clinic/Other health care facility"}