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Search / Trial NCT00646243

Echo Assessment of Intraventricular Dyssynchrony

Launched by ITALIAN SOCIETY OF CARDIOLOGY · Mar 27, 2008

Trial Information

Current as of May 27, 2025

Unknown status

Keywords

Heart Failure Echocardiography Cardiac Resynchronization Therapy Left Ventricular Dyssynchrony

ClinConnect Summary

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 feasibility and reproducibility of such indexes in healthy subjects and in HF patients undergoing implantation of a biventricular pacemaker;
3. definition of the accuracy of such indexes for predicting response to CRT.

STUDY DESIGN. Multicenter, prospective, observational study that will be carried out in 6 Italian sites of acknowledged expertise in LV DYS evaluation and biventricular pacemaker impl...

Gender

ALL

Eligibility 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.

About Italian Society Of Cardiology

The Italian Society of Cardiology (Società Italiana di Cardiologia, SIC) is a leading professional organization dedicated to advancing cardiovascular health through research, education, and clinical practice in Italy. Committed to improving patient outcomes, the SIC sponsors clinical trials that aim to enhance the understanding and treatment of cardiovascular diseases. By fostering collaboration among healthcare professionals, researchers, and institutions, the Society plays a pivotal role in promoting innovative therapies and guidelines that align with the latest scientific advancements. Through its rigorous oversight and commitment to ethical standards, the SIC ensures that its clinical trials contribute valuable insights to the field of cardiology and improve the quality of care for patients nationwide.

Locations

Udine, , Italy

Patients applied

0 patients applied

Trial Officials

Luigi P. Badano, M.D.

Principal Investigator

Ospedale Universitario di Udine

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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