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

Sponsor

Ospedale Santa Maria di Loreto Mare (Other)

Overall Status

Unknown status

CT.gov ID

NCT00828360

Collaborator

(none)

270

Enrollment

Locations

Duration (Months)

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

270 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jul 1, 2006

Anticipated Primary Completion Date :

Apr 1, 2009

Anticipated Study Completion Date :

Sep 1, 2009

Outcome Measures

Primary Outcome Measures

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]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Anthea Clinic	Bari	Italy
2	Sant'Anna Hospital	Catanzaro	Italy
3	Istituto Clinico Humanitas	Milan	Italy	20100
4	Ospedale Santa Maria di Loreto Mare	Naples	Italy	80142
5	Santa Maria della Misericordia	Rovigo	Italy