Left Ventricular Dyssynchrony Clinical Trial
Official title:
Left Ventricular Dyssynchrony: Rest/Stress 3D Blood-Pool Gated D-SPECT Quantification With a High-Speed Dedicated Cardiac Camera Before CRT
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | October 2011 |
Est. primary completion date | August 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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, |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
France | CHU de CLERMONT-FERRAND | Clermont-Ferrand |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Clermont-Ferrand | Centre Jean Perrin |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Left ventricular phase standard deviation. | Yes | ||
Secondary | Left ventricular entropy | Yes | ||
Secondary | Left ventricle ejection fraction | Yes | ||
Secondary | Quality of life. | Yes | ||
Secondary | 6-minutes walking test | Yes |
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