Importance of ARB medication in preventing valvular heart disease

Phase 1

• Conditions: Aortic valve stenosis; MedDRA version: 20.0Level: PTClassification code 10002918Term: Aortic valve stenosisSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2018-004653-24-DK
• Lead Sponsor: Odense Universitets Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-04
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

1.Patients with mild-moderate AS (peak aortic jet velocity =2.5 and <4m/s)
2. Age >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

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 <30ml/min/1.73m2)
3. Known allergy or intolerance to ARBs, poorly controlled blood
pressure
4. Renal dysfunction (estimated glomerular filtration
rate <30ml/min/1.73m2), chronic hyperkalemia (P-potassium >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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified