The effectiveness of cardiac work in patients with narrowed aortic valve - a prognostic marker and a target for intervention?

Conditions: Aortic stenosis
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2013-001147-31-DK

Lead Sponsor: Aarhus University Hospital, Department of Cardiology

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- Aortic valve area <1,2 cm2 and/or transaortic maximal velocity (VmaxAO) of 3,0-5,0 m/s
- Sinus rhythm >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

- Systolic BP <100 mmHg after 5 minutes of rest
- Left ventricular posterior wall thickness >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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): - Myocardial oxygen consumption<br>- Myocardial perfusion at rest <br>- LV myocardial function – evaluated by global longitudinal strain, EF and diastolic function<br>- LVmass<br>- Aortic valve area and transaortic valve velocities<br>- 6 minute walking distance <br>- N-terminal prohormone of brain natriuretic peptide <br>- Quality of life - estimated by Minnesota living with heart failure questionnaire<br>- LV wall stress;Timepoint(s) of evaluation of this end point: Baseline and at end of study (22 weeks)