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

Heart Failure Clinical Trial

— LODO-CRT  

Official title:

Efficacy Of Low-Dose Dobutamine Stress-Echocardiography To Predict Cardiac Resynchronization Therapy Response

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00828360
• Other study ID #: LM-001
• Status: Active, not recruiting
• Phase: N/A
• First received: January 22, 2009
• Last updated: January 22, 2009
• Start date: July 2006
• Est. completion date: September 2009

Study information

• Verified date: January 2009
• Source: Ospedale Santa Maria di Loreto Mare
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 270
• Est. completion date: September 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
Italy	Anthea Clinic	Bari
Italy	Sant'Anna Hospital	Catanzaro
Italy	Istituto Clinico Humanitas	Milan
Italy	Ospedale Santa Maria di Loreto Mare	Naples
Italy	Santa Maria della Misericordia	Rovigo

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Santa Maria di Loreto Mare

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. doi: 10.1016/j.ahj.2008.06.011. Epub 2008 Aug 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		6 months	No
Secondary	Clinical composite score, which combines changes in the NYHA class and global assessment with the information provided from the occurrence of major clinical events.		12 months	No