Aortic stenosis
Conditions
Interventions
Trade Name: Metoprololsuccinat "Hexal"
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Aarhus University Hospital, Department of Cardiology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Aortic valve area 60/min after 5 minutes rest - LVEF >55% - Male or female - Age 20-100 years old - Safe birth control management (intrauterine devices or hormonal contraceptives (contraceptive pills, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release)) - Negative urine-HCG for women of childbearing potential - Ability to understand the written patient information and to give 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 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: - Systolic BP 17 mm - Signs or history of myocardial infarction and/or severe ischemic heart disease - Severe asthma or chronic obstructive pulmonary disease - New York Heart Association (NYHA) classification > I due to AS - NYHA > II due to non-cardiac causes - 2? or 3? atrioventricular block - Ongoing beta-blocker therapy - Ongoing verapamil or diltiazem therapy - Ongoing monoamine oxidase inhibitors therapy - Sick sinus syndrome - Atrial fibrillation or fluttering - Lack of stable sinus rhythm - Pheochromocytoma - Severe peripheral vascular disease - Intolerance of metoprolol succinate or its excipients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate in a randomized, double-blinded placebo controlled design if beta-blocker treatment in patients with moderate to severe, asymptomatic AS has beneficial effects on LV myocardial oxidative metabolism, efficiency, contractile function and physical performance.;Secondary Objective: Not applicable;Primary end point(s): - Myocardial efficiency;Timepoint(s) of evaluation of this end point: Baseline and at end of study (22 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Myocardial oxygen consumption - Myocardial perfusion at rest - LV myocardial function – evaluated by global longitudinal strain, EF and diastolic function - LVmass - Aortic valve area and transaortic valve velocities - 6 minute walking distance - N-terminal prohormone of brain natriuretic peptide - Quality of life - estimated by Minnesota living with heart failure questionnaire - LV wall stress;Timepoint(s) of evaluation of this end point: Baseline and at end of study (22 weeks) | — |
Countries
Denmark
Contacts
Public ContactNils Henrik Hansson
Department of Cardiology, Aarhus University Hospital
Outcome results
None listed