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.
Conditions
Interventions
Trade Name: Captol
Product Name: Captopril
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Trandolapril
Product Nam
Sponsors
Rigshospitalet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Valvular aortic stenosis with a aortic valve area 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
Exclusion criteria: Sitting systolic pressure 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Treatment with ACE-inhibitors improves haemodynamic parameters in patients with severe aorta stenosis. Effect parameters are changes in cardiac output, cardiac index and wedge pressure. Values will be measured both at rest and during exercise.;Secondary Objective: Treatment with ACE-inhibitors increases working capacity in patients with severe aorta stenosis. Treatment with ACE-inhibitors improves systolic and diastolic function on left ventricle. Effect parameters are changes in left ventricle ejection fraction, the size of left atria, deceleration time of the E-wave and strain rate. Treatment with ACE-inhibitors in patients with severe aorta stenosis is safe. Effect parameters are drop in systolic blood pressure and symptoms on hypotension (syncope or hypotension). Increasing creatinine more than 20 %. Treatment with ACE-inhibitors decrease wall stress in left ventricle. Effect is measured changes in BNP. Results of the aforementioned investigations from symptomatic and asymptomatic patients are the same at rest but different at work. Therefore all values will be measured at rest and during exercise. ;Primary end point(s): Treatment with ACE-inhibitors improves haemodynamic parameters in patients with severe aortic stenosis. The effect parameter is changes cardiac index. Values will be measured both at rest and during exercise. | — |
Countries
Denmark
Outcome results
None listed