Dobutamine Stress Echocardiography in Cardiac Resynchronization Therapy (CRT) Patients Selection (LODO-CRT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Ospedale Santa Maria di Loreto Mare.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Ospedale Santa Maria di Loreto Mare
ClinicalTrials.gov Identifier:
NCT00828360
First received: January 22, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted

January 22, 2009
January 22, 2009
July 2006
April 2009   (final data collection date for primary outcome measure)
Number of patients showing left ventricular reverse remodelling. In particular, a 10% or greater reduction of the left ventricular end-systolic volume (LVESV) is the primary endpoint of the LODO-CRT study. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Clinical composite score, which combines changes in the NYHA class and global assessment with the information provided from the occurrence of major clinical events. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Dobutamine Stress Echocardiography in Cardiac Resynchronization Therapy (CRT) Patients Selection
Efficacy Of Low-Dose Dobutamine Stress-Echocardiography To Predict Cardiac Resynchronization Therapy Response

While cardiac resynchronization therapy (CRT) has a well demonstrated therapeutic effect in selected patients with advanced heart failure (HF) on optimized drug therapy, non-responder rate remains high. The low-dose dobutamine stress-echo (DSE) test to predict positive response to CRT (LODO-CRT) trial is designed to improve patient selection for CRT.

LODO-CRT is a multicenter prospective study enrolling HF patients with conventional indication to CRT (symptomatic stable NYHA class III-IV on optimized drug therapy, QRS≥120 msec, left ventricular (LV) dilatation, LVEF≤35%) is designed to assess the predictive value of LV contractile reserve (LVCR), determined through DSE, in predicting CRT response during follow-up. Assessment of CRT effects will follow two sequential phases: in phase 1 CRT response end-point is defined as left ventricular end-systolic volume (LVESV) reduction ≥ 10% at 6 months; in phase 2, both LVESV reduction and clinical status via a clinical composite score will be evaluated at 12 months follow-up. Predictive value of LVCR will be compared to other measures, such as LV dyssynchrony measures, through adjusted multivariable analysis. For the purpose of the study, target patient number is 270 patients (with 95% confidence, 80% power, α≤0.05).

LVCR assessment, using low-dose DES test, should effectively predict positive response to CRT both in terms of the reverse remodeling process as well as favorable long-term clinical outcome. Moreover, the predictive value of LVCR will be compared to that of conventional intra-LV dyssynchrony measures.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

Patient indicated to CRT according to current guidelines

Heart Failure
Not Provided
Not Provided
Muto C, Gasparini M, Iacopino S, Peraldo C, Curnis A, Sassone B, Diotallevi P, Davinelli M, Valsecchi S, Tuccillo B. Efficacy of LOw-dose DObutamine stress-echocardiography to predict cardiac resynchronization therapy response (LODO-CRT) multicenter prospective study: design and rationale. Am Heart J. 2008 Oct;156(4):656-61. Epub 2008 Aug 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
270
September 2009
April 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • severe HF despite optimized medical therapy
  • NYHA functional class III-IV
  • dilated cardiomyopathy of both ischemic and non-ischemic origin
  • left ventricular ejection fraction (LVEF) <=35%
  • QRS complex duration ≥120 ms
  • normal sinus rhythm.

Exclusion Criteria:

  • younger than 18 years old
  • unstable angina
  • acute myocardial infarction
  • coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within the past 3 months
  • already implanted with a conventional implantable pulse generator or with an implantable cardioverter defibrillator (ICD)
  • previously implanted with a CRT device
  • chronic permanent atrial arrhythmias
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00828360
LM-001
No
Dr. Carmine Muto, Ospedale Santa Maria di Loreto Mare Napoli
Ospedale Santa Maria di Loreto Mare
Not Provided
Principal Investigator: Carmine Muto, MD Ospedale Santa Maria di Loreto Mare Naples
Ospedale Santa Maria di Loreto Mare
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP