Echo Assessment of Intraventricular Dyssynchrony (IMPROVE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by Italian Society of Cardiology.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Italian Society of Cardiology
ClinicalTrials.gov Identifier:
NCT00646243
First received: March 25, 2008
Last updated: March 27, 2008
Last verified: March 2008
  Purpose

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
Chronic Heart Failure
Ischemic Heart Disease
Dilated Cardiomyopathy

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

Resource links provided by NLM:


Further study details as provided by Italian Society of Cardiology:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 336
Study Start Date: March 2008
Estimated Study Completion Date: March 2009
Groups/Cohorts
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Consecutive consenting patients candidate to cardiac resynchronization therapy by clinical and electrocardiographic criteria.

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00646243

Contacts
Contact: Luigi P. Badano, M.D. +39 0432 554557 badano.luigi@aoud.sanita.fvg.it

Locations
Italy
Department of Cardiopulmonary Sciences - Ospedale Universitario Not yet recruiting
Udine, Italy, 33100
Contact: Luigi P. Badano, M.D.    +39 0432 554557    badano.luigi@aoud.sanita.fvg.it   
Principal Investigator: Luigi P Badano, M.D.         
Sub-Investigator: Federica Oliana, M.D.         
Sponsors and Collaborators
Italian Society of Cardiology
Investigators
Principal Investigator: Luigi P. Badano, M.D. Ospedale Universitario di Udine
  More Information

Publications:

Responsible Party: Luigi P. Badano, M.D., Ospedale Universitario di Udine
ClinicalTrials.gov Identifier: NCT00646243     History of Changes
Other Study ID Numbers: IMPROVE
Study First Received: March 25, 2008
Last Updated: March 27, 2008
Health Authority: Italy: Ethics Committee

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

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

ClinicalTrials.gov processed this record on August 26, 2014