WItten heaRt failurE in Aortic Stenosis study - Prospective diagnostic study to investigate the hemodynamic basis of an irreversible left ventricular failure in severe aortic stenosis
- Conditions
- I35.0I42.8Aortic (valve) stenosisOther cardiomyopathies
- Registration Number
- DRKS00009993
- Lead Sponsor
- Kardiogische Klinik, Marien-Hospital Witten, Ruhr-Universität Bochum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion criteria study group aortic stenosis and left ventricular failure
- Severe aortic stenosis ( valve area < 1 cm ²)
- Left ventricular dysfunction (left ventricular ejection fraction = 40%)
- Symptoms of heart failure (NYHA II -IV)
- Age = 18 years
- Life expectancy > 1 years
- Consent to participate in the study
Inclusion criteria control group aortic stenosis without left ventricular failure
- Severe aortic stenosis ( valve area < 1 cm ²)
- Received left ventricular ejection fraction ( = 50%)
- Symptoms of heart failure (NYHA II -IV)
- Age = 18 years
- Life expectancy > 1 years
- Consent to participate in the study
- Active endocarditis
- Previous heart surgery
- Concurrent serious stenosis or insufficiency of the mitral valve
- Concurrent serious insufficiency of the aortic valve
- Pregnancy, lactation
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of reversible and irreversible left ventricular failure in terms of the end-systolic pressure-volume relationship (ESPVR) - measured with conductance catheter - before aortic valve replacement
- Secondary Outcome Measures
Name Time Method Comparison of reversible and irreversible left ventricular failure:<br>- All-cause mortality (one-year)<br>- Cardiovascular mortality (one-year)<br>- Hospitalization for heart failure (within the first year after aortic valve replacement)<br>- Distance in the 6-minute walk test before and 3 months after aortic valve replacement<br>