Heart FailureLODO-CRTNCT00828360
Dobutamine Stress Echocardiography in Cardiac Resynchronization Therapy (CRT) Patients Selection
An observational study of Heart Failure, run by Ospedale Santa Maria di Loreto Mare at 5 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 270 participants
- Where
- 5 sitesItaly
- Study dates
- Jul 2006to Sep 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient indicated to CRT according to current guidelines
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Italy5 sites
Anthea Clinic
Bari
Sant'Anna Hospital
Catanzaro
Istituto Clinico Humanitas
Milan, 20100
Ospedale Santa Maria di Loreto Mare
Naples, 80142
Santa Maria della Misericordia
Rovigo
About this study
Official title: 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.
Read the 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.
- Conditions
- Heart Failure
- Keywords
- Heart Failure, CRT, Dobutamine echocardiography
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2009 (estimated)
- Study startJul 2006
- Primary completionApr 2009 (estimated)
- Study completionSep 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale Santa Maria di Loreto Mare
- Sponsor type
- University, hospital or other
- Investigators
- Carmine Muto, MD, Principal investigator, Ospedale Santa Maria di Loreto Mare Naples
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00828360
- Sponsor's protocol ID
- LM-001
- Acronym
- LODO-CRT
- Status last verified
- Jan 2009
- First submitted
- 22 Jan 2009
- Last updated
- 23 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18926147
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Of Low-Dose Dobutamine Stress-Echocardiography To Predict Cardiac Resynchronization Therapy Response
- ClinicalTrials.gov ID
- NCT00828360
- Acronym / sponsor ID
- LODO-CRT / LM-001
- Conditions
- Heart Failure
- Keywords
- Heart Failure, CRT, Dobutamine echocardiography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Ospedale Santa Maria di Loreto MareUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Apr 2009 (estimated)
- Study completion
- Sep 2009 (estimated)
- First posted
- 23 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient indicated to CRT according to current guidelines
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2009.
- Background: PubMed 18926147Muto 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmine Muto, MD principal investigator
Ospedale Santa Maria di Loreto Mare Naples
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Ospedale Santa Maria di Loreto Mare at 5 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00828360, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2009.