Dobutamine Stress Echocardiography in Cardiac Resynchronization Therapy (CRT) Patients Selection
LODO-CRT
Efficacy Of Low-Dose Dobutamine Stress-Echocardiography To Predict Cardiac Resynchronization Therapy Response
1 other identifier
observational
270
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2006
Typical duration for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 22, 2009
CompletedFirst Posted
Study publicly available on registry
January 23, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedJanuary 23, 2009
January 1, 2009
2.8 years
January 22, 2009
January 22, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Patient indicated to CRT according to current guidelines
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Anthea Clinic
Bari, Italy
Sant'Anna Hospital
Catanzaro, Italy
Istituto Clinico Humanitas
Milan, 20100, Italy
Ospedale Santa Maria di Loreto Mare
Naples, 80142, Italy
Santa Maria della Misericordia
Rovigo, Italy
Related 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.
PMID: 18926147BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carmine Muto, MD
Ospedale Santa Maria di Loreto Mare Naples
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 22, 2009
First Posted
January 23, 2009
Study Start
July 1, 2006
Primary Completion
April 1, 2009
Study Completion
September 1, 2009
Last Updated
January 23, 2009
Record last verified: 2009-01