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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Ospedale Santa Maria di Loreto Mare.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Ospedale Santa Maria di Loreto Mare
ClinicalTrials.gov Identifier:
NCT00828360
First received: January 22, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  Purpose

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
Heart Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Efficacy Of Low-Dose Dobutamine Stress-Echocardiography To Predict Cardiac Resynchronization Therapy Response

Resource links provided by NLM:


Further study details as provided by Ospedale Santa Maria di Loreto Mare:

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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 270
Study Start Date: July 2006
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patient indicated to CRT according to current guidelines

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00828360

Locations
Italy
Anthea Clinic
Bari, Italy
Sant'Anna Hospital
Catanzaro, Italy
Istituto Clinico Humanitas
Milan, Italy, 20100
Ospedale Santa Maria di Loreto Mare
Naples, Italy, 80142
Santa Maria della Misericordia
Rovigo, Italy
Sponsors and Collaborators
Ospedale Santa Maria di Loreto Mare
Investigators
Principal Investigator: Carmine Muto, MD Ospedale Santa Maria di Loreto Mare Naples
  More Information

Publications:
Responsible Party: Dr. Carmine Muto, Ospedale Santa Maria di Loreto Mare Napoli
ClinicalTrials.gov Identifier: NCT00828360     History of Changes
Other Study ID Numbers: LM-001
Study First Received: January 22, 2009
Last Updated: January 22, 2009
Health Authority: Italy: Ministry of Health

Keywords provided by Ospedale Santa Maria di Loreto Mare:
Heart Failure
CRT
Dobutamine echocardiography

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Dobutamine
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on September 18, 2014