Clinical trial NCT00828360: Dobutamine Stress Echocardiography in Cardiac Resynchronization Therapy (CRT) Patients Selection
Official title: Efficacy Of Low-Dose Dobutamine Stress-Echocardiography To Predict Cardiac Resynchronization Therapy Response
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Keywords: Heart Failure
CRT
Dobutamine echocardiography
Lead sponsor: Ospedale Santa Maria di Loreto Mare
Sponsor class: OTHER
First posted: 2009-01-23
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient indicated to CRT according to current guidelines

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.

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.

Eligibility criteria: 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

Primary outcomes:
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.
timeFrame: 6 months
Secondary outcomes:
measure: Clinical composite score, which combines changes in the NYHA class and global assessment with the information provided from the occurrence of major clinical events.
timeFrame: 12 months
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Anthea Clinic
city: Catanzaro
country: Italy
facility: Sant'Anna Hospital
city: Milan
country: Italy
facility: Istituto Clinico Humanitas
city: Naples
country: Italy
facility: Ospedale Santa Maria di Loreto Mare
city: Rovigo
country: Italy
facility: Santa Maria della Misericordia
Study officials:
affiliation: Ospedale Santa Maria di Loreto Mare Naples
name: Carmine Muto, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.