Echo Assessment of Intraventricular Dyssynchrony (IMPROVE)
Recruitment status was: Not yet recruiting
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 surface electrocardiogram. However, there is a growing evidence that QRS duration poorly predicts responses to CRT, and that ~30% of patients do not experience any benefit from CRT when pre-implant dyssynchrony is defined according to electrocardiographic criteria. A number of echocardiographic criteria have been proposed to assess mechanical LV dyssynchrony, but at present there is no consensus on their use to predict response to CRT.
Study Design. The Italian Multicenter PROject on echo assessment of left VEntricular (IMPROVE) dyssynchrony study is a prospective, multicenter, observational study aimed to assess feasibility and predictive power of mechanical dyssynchrony assessed by echocardiography in consecutive consenting patients candidate to CRT by clinical and electrocardiographic criteria. IMPROVE will enroll 120 healthy subjects and 216 HF patients in 6 sites in Italy. CRT response criteria will be based on improvement in NYHA class and LV reverse remodeling evaluated by 3D-echocardiography. Enrollment is expected to conclude early 2009.
Implications. CRT is today part of the therapeutic armamentarium for symptomatic HF patients refractory to medical therapy, with wide QRS complex and severe LV systolic dysfunction. The IMPROVE study has been designed to evaluate reference values of indexes of ultrasound mechanical dyssynchrony that have been proposed in the literature and compare their ability to predict response to CRT in HF patients.
Chronic Heart Failure
Ischemic Heart Disease
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Italian Multicenter PROject on Echo Assessment of Left VEntricular (IMPROVE) Dyssynchrony Study|
- Prediction of the combined end-point defined as NYHA class improvement by at least one grade and echocardiographic left ventricular end-systolic volume decrease by at least 10% with respect to baseline (variations are considered as relative values); [ Time Frame: 3 months after biventricular pace-maker implant ] [ Designated as safety issue: No ]
- Feasibility and repeatibility of echocardiographic indexes of intraventricular dyssynchrony [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- definition of reference values of echocardiographic mechanical dyssynchrony indexes in a population of healthy subjects; [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||March 2008|
|Estimated Study Completion Date:||March 2009|
1 Heart Failure
216 consecutive consenting patients with refractory heart failure candidate to cardiac resynchronization therapy by clinical and electrocardiographic criteria
2 Healthy subjects
120 healthy subject includes defined as absence of history and symptoms of any cardiovascular disease, normal physical examination and ECG.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00646243
|Department of Cardiopulmonary Sciences - Ospedale Universitario|
|Udine, Italy, 33100|
|Principal Investigator:||Luigi P. Badano, M.D.||Ospedale Universitario di Udine|