Echo Assessment of Intraventricular Dyssynchrony (IMPROVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00646243
Recruitment Status : Unknown
Verified March 2008 by Italian Society of Cardiology.
Recruitment status was:  Not yet recruiting
First Posted : March 28, 2008
Last Update Posted : March 28, 2008
Information provided by:
Italian Society of Cardiology

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 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.

Condition or disease
Chronic Heart Failure Ischemic Heart Disease Dilated Cardiomyopathy

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 336 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Italian Multicenter PROject on Echo Assessment of Left VEntricular (IMPROVE) Dyssynchrony Study
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.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Feasibility and repeatibility of echocardiographic indexes of intraventricular dyssynchrony [ Time Frame: 6 months ]
  2. definition of reference values of echocardiographic mechanical dyssynchrony indexes in a population of healthy subjects; [ Time Frame: 12 months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Consecutive consenting patients candidate to cardiac resynchronization therapy by clinical and electrocardiographic criteria.

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00646243

Contact: Luigi P. Badano, M.D. +39 0432 554557

Department of Cardiopulmonary Sciences - Ospedale Universitario Not yet recruiting
Udine, Italy, 33100
Contact: Luigi P. Badano, M.D.    +39 0432 554557   
Principal Investigator: Luigi P Badano, M.D.         
Sub-Investigator: Federica Oliana, M.D.         
Sponsors and Collaborators
Italian Society of Cardiology
Principal Investigator: Luigi P. Badano, M.D. Ospedale Universitario di Udine


Responsible Party: Luigi P. Badano, M.D., Ospedale Universitario di Udine Identifier: NCT00646243     History of Changes
Other Study ID Numbers: IMPROVE
First Posted: March 28, 2008    Key Record Dates
Last Update Posted: March 28, 2008
Last Verified: March 2008

Keywords provided by Italian Society of Cardiology:
Heart failure
cardiac resynchronization therapy
left ventricular dyssynchrony

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Cardiomyopathy, Dilated
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arterial Occlusive Diseases