The effect of medical treatment (metoprolol) on heart failure caused by aortic regurgitatio
- Conditions
- The aim of the present study is therefore to assess the effect of a 6 month treatment with beta-blocker on left ventricular remodeling and function in patients with asymptomatic moderate to severe aortic regurgitation.(ii)Patients in stable clinical situation(iii)Have LVEF >55%, (iv)Have an end diastolic diameter (on echo) of 50-60 mmMedDRA version: 14.1Level: LLTClassification code 10002904Term: Aortic regurgitationSystem Organ Class: 100000004849Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
- Registration Number
- EUCTR2007-000518-34-DK
- Lead Sponsor
- Rikshospitalet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 70
The criteria for enrollment in the study are asymptomatic aortic regurgitation of moderate to severe degree..
Inclusion criteria
(i)Age of 18-70 years
(ii)Stable clinical situation
(iii)Have LVEF >55%,
(iv)Have an end diastolic diameter (on echo) of 50-60 mm
(v)Have given written informed consent
(vi)No planned surgery
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 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15
(i)Evidence of unstable disease
(ii)Mixed aortic stenosis and regurgitation (valve gradients > 20 mm Hg).
(iii)evidence of additional valvular or congenital heart disease on echocardiographic or Doppler study
(iv)EF< 55%
(v)LVESD>55 mm
(vi)Heart rate < 50 bpm
(vii)Other illnesses or treatments which reduces the safety and/or efficacy of the treatment
(viii)Participating in other studies
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method