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Acute haemodynanic effects of Treatment with ACE inhibitores in patients with severe Aortic Stenosis

Phase 1
Conditions
Aortic valve stenosis is a reduction of the aortic valve orifice to a degree where emptying of the left ventricule is compromised. The two major causes for aortic valve stenosis is calcific valve disease and congenital heart disease. Calcific aortic valve disease is common, affecting 2-9 percent of the elderly. The prognosis is very poor for patients with severe aortic stenosis. The only effective treatment available is surgical intervention with insertion of a valvular prosthesis.
Registration Number
EUCTR2005-002580-85-DK
Lead Sponsor
Rigshospitalet
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
64
Inclusion Criteria

Valvular aortic stenosis with a aortic valve area <1,0 cm2
Age > 18 years
Willingness to give written informed consent
For patients with symptomatic aortic stenosis at least one of following
Stable angina pectoris
Syncope at exertion
Dizziness at exertion
Previous pulmonary oedema
Patients in New York Heart Association functional class II-IV

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Sitting systolic pressure < 100 mmHg
Creatinine > 200 mM at screening
Renal artery stenosis
Pregnancy or planned pregnancy
Participation in other studies
Any patient characteristic that may interfere with compliance to the study protocol
Treated with ACE-inhibitor or angiotensin receptor blocker within the last month
Known allergy to ACE-inhibitors

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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