Rest/Stress Quantification Of Left Ventricular Dyssynchrony By 3D Gated Blood Pool D-SPECT

Not Applicable

• Conditions: Left Ventricular Dyssynchrony

• Registration Number: NCT01390532
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

Cardiac Resynchronization Therapy (CRT) is an established treatment for patients with advanced heart failure and left ventricular dyssynchrony (LVD). Too many patients do not clinically improve with CRT. New LVD markers other than QRS duration are needed.

Study objective : feasibility assessment of rest and real-time stress 3D Blood-Pool Gated SPECT (BPGS) with a new designed cardiac imaging camera (DSPECT, Spectrum Dynamics®, Ceasaria, Israel) to quantify LVD.

Detailed Description

Sequential 5 min Gated blood pool D-SPECT acquisition at rest and during last stage of dobutamine and atropin infusion (\>85% PHR).

Rest and stress left ventricular ejection fraction, phase standard deviation and entropy will be determined using a fully automatic commercial software (QBS, Cedars-Sinai, Los Angeles, CA).

Study Timeline

• Study Start: 2010-08
• Status Verified: 2011-07
• Study First Submitted: 2011-07-07
• Study First Submitted QC: 2011-07-08
• Last Update Submitted: 2011-07-08
• Study First Posted: 2011-07-11
• Last Update Posted: 2011-07-11
• Primary Completion: 2011-08
• Study Completion: 2011-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Chronic heart failure with LVEF < 35 %, QRS > 120 ms, NYHA III/IV, optimal medical therapy for more than one month.

• Patient with stable hemodynamic for more than one month,
• More than 18-year old man or woman,
• Patient having given his free, inform and signed consent,
• Patient place setting by the social security system,

Exclusion Criteria

• Psychiatric disorder
• Any contra-indication to Technetium,
• Any contra-indication to dobutamin or atropin
• Personal or family history of sudden death
• Previous severe ventricular arrhythmia
• Obstructive cardiomyopathy, severe aortic stenosis,
• Pulmonary hypertension,
• History of renal, lung, hepatic, cardiac transplantation,
• Pregnant or breast-feeding Woman,
• Patient who can not conform to the requirements of the protocol,
• Patient included in another medical study,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Left ventricular phase standard deviation.

Secondary Outcome Measures

Name	Time	Method
Left ventricular entropy
Left ventricle ejection fraction
Quality of life.
6-minutes walking test

Trial Locations

Locations (1)

CHU de CLERMONT-FERRAND; 🇫🇷 Clermont-Ferrand, France