Echo Assessment of Intraventricular Dyssynchrony

NCT00646243 | Unknown

• 1 other identifier: IMPROVE
• Study Type: observational
• Target: 336
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Heart Failure; Ischemic Heart Disease; Dilated Cardiomyopathy

Keywords

Heart failure; echocardiography; cardiac resynchronization therapy; left ventricular dyssynchrony

Outcome Measures

Primary Outcomes (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);

  3 months after biventricular pace-maker implant

Secondary Outcomes (2)

• Feasibility and repeatibility of echocardiographic indexes of intraventricular dyssynchrony

  6 months

• definition of reference values of echocardiographic mechanical dyssynchrony indexes in a population of healthy subjects;

  12 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Italian Society of Cardiology: lead

Study Sites (1)

Department of Cardiopulmonary Sciences - Ospedale Universitario

Udine, 33100, Italy

Location

Related Publications (20)

• McAlister FA, Ezekowitz J, Hooton N, Vandermeer B, Spooner C, Dryden DM, Page RL, Hlatky MA, Rowe BH. Cardiac resynchronization therapy for patients with left ventricular systolic dysfunction: a systematic review. JAMA. 2007 Jun 13;297(22):2502-14. doi: 10.1001/jama.297.22.2502.

  PMID: 17565085 BACKGROUND

• Hawkins NM, Petrie MC, MacDonald MR, Hogg KJ, McMurray JJ. Selecting patients for cardiac resynchronization therapy: electrical or mechanical dyssynchrony? Eur Heart J. 2006 Jun;27(11):1270-81. doi: 10.1093/eurheartj/ehi826. Epub 2006 Mar 9.

  PMID: 16527827 BACKGROUND

• Mollema SA, Bleeker GB, van der Wall EE, Schalij MJ, Bax JJ. Usefulness of QRS duration to predict response to cardiac resynchronization therapy in patients with end-stage heart failure. Am J Cardiol. 2007 Dec 1;100(11):1665-70. doi: 10.1016/j.amjcard.2007.06.071. Epub 2007 Oct 24.

  PMID: 18036366 BACKGROUND

• Bax JJ, Abraham T, Barold SS, Breithardt OA, Fung JW, Garrigue S, Gorcsan J 3rd, Hayes DL, Kass DA, Knuuti J, Leclercq C, Linde C, Mark DB, Monaghan MJ, Nihoyannopoulos P, Schalij MJ, Stellbrink C, Yu CM. Cardiac resynchronization therapy: Part 1--issues before device implantation. J Am Coll Cardiol. 2005 Dec 20;46(12):2153-67. doi: 10.1016/j.jacc.2005.09.019.

  PMID: 16360042 BACKGROUND

• Badano LP, Baldassi M, Ghio S, Mele D, Rigo F, Trambaiolo P, Fioretti PM. [Selection of patients undergoing cardiac resynchronization therapy: role of echocardiography]. G Ital Cardiol (Rome). 2006 Nov;7(11):724-38. Italian.

  PMID: 17216914 BACKGROUND

• Yu CM, Abraham WT, Bax J, Chung E, Fedewa M, Ghio S, Leclercq C, Leon AR, Merlino J, Nihoyannopoulos P, Notabartolo D, Sun JP, Tavazzi L; PROSPECT Investigators. Predictors of response to cardiac resynchronization therapy (PROSPECT)--study design. Am Heart J. 2005 Apr;149(4):600-5. doi: 10.1016/j.ahj.2004.12.013.

  PMID: 15990740 BACKGROUND

• Cleland JG, Abdellah AT, Khaleva O, Coletta AP, Clark AL. Clinical trials update from the European Society of Cardiology Congress 2007: 3CPO, ALOFT, PROSPECT and statins for heart failure. Eur J Heart Fail. 2007 Oct;9(10):1070-3. doi: 10.1016/j.ejheart.2007.09.005. Epub 2007 Sep 24.

  PMID: 17890152 BACKGROUND

• Dohi K, Suffoletto MS, Schwartzman D, Ganz L, Pinsky MR, Gorcsan J 3rd. Utility of echocardiographic radial strain imaging to quantify left ventricular dyssynchrony and predict acute response to cardiac resynchronization therapy. Am J Cardiol. 2005 Jul 1;96(1):112-6. doi: 10.1016/j.amjcard.2005.03.032.

  PMID: 15979447 BACKGROUND

• Suffoletto MS, Dohi K, Cannesson M, Saba S, Gorcsan J 3rd. Novel speckle-tracking radial strain from routine black-and-white echocardiographic images to quantify dyssynchrony and predict response to cardiac resynchronization therapy. Circulation. 2006 Feb 21;113(7):960-8. doi: 10.1161/CIRCULATIONAHA.105.571455. Epub 2006 Feb 13.

  PMID: 16476850 BACKGROUND

• Porciani MC, Lilli A, Macioce R, Cappelli F, Demarchi G, Pappone A, Ricciardi G, Padeletti L. Utility of a new left ventricular asynchrony index as a predictor of reverse remodelling after cardiac resynchronization therapy. Eur Heart J. 2006 Aug;27(15):1818-23. doi: 10.1093/eurheartj/ehl133. Epub 2006 Jul 3.

  PMID: 16818457 BACKGROUND

• Mele D, Pasanisi G, Capasso F, De Simone A, Morales MA, Poggio D, Capucci A, Tabacchi G, Sallusti L, Ferrari R. Left intraventricular myocardial deformation dyssynchrony identifies responders to cardiac resynchronization therapy in patients with heart failure. Eur Heart J. 2006 May;27(9):1070-8. doi: 10.1093/eurheartj/ehi814. Epub 2006 Mar 30.

  PMID: 16574689 BACKGROUND

• Kapetanakis S, Kearney MT, Siva A, Gall N, Cooklin M, Monaghan MJ. Real-time three-dimensional echocardiography: a novel technique to quantify global left ventricular mechanical dyssynchrony. Circulation. 2005 Aug 16;112(7):992-1000. doi: 10.1161/CIRCULATIONAHA.104.474445. Epub 2005 Aug 8.

  PMID: 16087800 BACKGROUND

• Marsan NA, Bleeker GB, Ypenburg C, Ghio S, van de Veire NR, Holman ER, van der Wall EE, Tavazzi L, Schalij MJ, Bax JJ. Real-time three-dimensional echocardiography permits quantification of left ventricular mechanical dyssynchrony and predicts acute response to cardiac resynchronization therapy. J Cardiovasc Electrophysiol. 2008 Apr;19(4):392-9. doi: 10.1111/j.1540-8167.2007.01056.x. Epub 2007 Dec 20.

  PMID: 18179529 BACKGROUND

• Pitzalis MV, Iacoviello M, Romito R, Massari F, Rizzon B, Luzzi G, Guida P, Andriani A, Mastropasqua F, Rizzon P. Cardiac resynchronization therapy tailored by echocardiographic evaluation of ventricular asynchrony. J Am Coll Cardiol. 2002 Nov 6;40(9):1615-22. doi: 10.1016/s0735-1097(02)02337-9.

  PMID: 12427414 BACKGROUND

• Sassone B, Capecchi A, Boggian G, Gabrieli L, Sacca S, Vandelli R, Petracci E, Mele D. Value of baseline left lateral wall postsystolic displacement assessed by M-mode to predict reverse remodeling by cardiac resynchronization therapy. Am J Cardiol. 2007 Aug 1;100(3):470-5. doi: 10.1016/j.amjcard.2007.02.107. Epub 2007 Jun 15.

  PMID: 17659931 BACKGROUND

• Bax JJ, Bleeker GB, Marwick TH, Molhoek SG, Boersma E, Steendijk P, van der Wall EE, Schalij MJ. Left ventricular dyssynchrony predicts response and prognosis after cardiac resynchronization therapy. J Am Coll Cardiol. 2004 Nov 2;44(9):1834-40. doi: 10.1016/j.jacc.2004.08.016.

  PMID: 15519016 BACKGROUND

• Gorcsan J 3rd, Kanzaki H, Bazaz R, Dohi K, Schwartzman D. Usefulness of echocardiographic tissue synchronization imaging to predict acute response to cardiac resynchronization therapy. Am J Cardiol. 2004 May 1;93(9):1178-81. doi: 10.1016/j.amjcard.2004.01.054.

  PMID: 15110219 BACKGROUND

• Yu CM, Chau E, Sanderson JE, Fan K, Tang MO, Fung WH, Lin H, Kong SL, Lam YM, Hill MR, Lau CP. Tissue Doppler echocardiographic evidence of reverse remodeling and improved synchronicity by simultaneously delaying regional contraction after biventricular pacing therapy in heart failure. Circulation. 2002 Jan 29;105(4):438-45. doi: 10.1161/hc0402.102623.

  PMID: 11815425 BACKGROUND

• Yu CM, Zhang Q, Fung JW, Chan HC, Chan YS, Yip GW, Kong SL, Lin H, Zhang Y, Sanderson JE. A novel tool to assess systolic asynchrony and identify responders of cardiac resynchronization therapy by tissue synchronization imaging. J Am Coll Cardiol. 2005 Mar 1;45(5):677-84. doi: 10.1016/j.jacc.2004.12.003.

  PMID: 15734610 BACKGROUND

• Butter C, Wellnhofer E, Seifert M, Schlegl M, Hoersch W, Goehring A, Fleck E. Time course of left ventricular volumes in severe congestive heart failure patients treated by optimized AV sequential left ventricular pacing alone--a 3-dimensional echocardiographic study. Am Heart J. 2006 Jan;151(1):115-23. doi: 10.1016/j.ahj.2005.02.047.

  PMID: 16368302 BACKGROUND

MeSH Terms

Conditions

Myocardial Ischemia; Cardiomyopathy, Dilated; Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cardiomegaly; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Luigi P. Badano, M.D.

  Ospedale Universitario di Udine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luigi P. Badano, M.D.

CONTACT

+39 0432 554557; badano.luigi@aoud.sanita.fvg.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 25, 2008
• First Posted: March 28, 2008
• Study Start: March 1, 2008
• Study Completion: March 1, 2009
• Last Updated: March 28, 2008

Record last verified: 2008-03

Locations

IT (1)