Status:
UNKNOWN
Echo Assessment of Intraventricular Dyssynchrony
Lead Sponsor:
Italian Society of Cardiology
Conditions:
Chronic Heart Failure
Ischemic Heart Disease
Eligibility:
All Genders
18+ years
Brief Summary
Background. Clinical benefits of cardiac resynchronization therapy (CRT) have been clearly demonstrated in heart failure (HF) patients with severe left ventricular (LV) dysfunction and wide QRS at sur...
Detailed Description
The IMPROVE study has 3 main purposes: 1. definition of reference values of echocardiographic mechanical dyssynchrony (DYS) indexes in a population of healthy subjects; 2. definition of the feasibili...
Eligibility Criteria
Inclusion
- Age \> 18 years.
- Sinus rhythm.
- Chronic heart failure (\>6 weeks duration) refractory to maximized drug therapy.
- NYHA class III-IV.
- LV ejection fraction less than 35% by RT3DE.
- Indexed LV end-diastolic diameter \>3.2 cm/m2 by 2D echocardiography and/or indexed end-diastolic volume \>75 ml/m2 by 3D echocardiography.
Exclusion
- Hypertrophic, restrictive, obstructive cardiomyopathy.
- Primitive and hemodynamically significant valve disease (defined as valvular stenosis greater than mild, and 3+ or 4+/4+ valvular regurgitations).
- Constrictive pericarditis.
- Primitive pulmonary hypertension.
- Uncorrected congential heart disease.
- Patients candidate to heart surgery.
- Patients with acute myocardial infarction, severe unstable angina and stroke that occurred within 6 weeks prior the study enrollment.
- Patients with life expectation \<1 year due to disease unrelated to the heart failure.
- Pregnant women.
- Refusal to give the informed consent.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2009
Estimated Enrollment :
336 Patients enrolled
Trial Details
Trial ID
NCT00646243
Start Date
March 1 2008
End Date
March 1 2009
Last Update
March 28 2008
Active Locations (1)
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1
Department of Cardiopulmonary Sciences - Ospedale Universitario
Udine, Italy, 33100