Myocardial Dyssynchrony and Sympathetic activity by cardiac gated-SPECT in patients with heart failure treated with cardiac resynchronyzation - ND

• Conditions: Heart failure; MedDRA version: 9.1Level: SOCClassification code 10007541; MedDRA version: 9.1Level: HLTClassification code 10007635

• Registration Number: EUCTR2008-006666-28-IT
• Lead Sponsor: AZIENDA OSPEDALIERA PISANA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-01
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Age >18 yrs and <80 yrs Male or female sex Fertile women declaring the use of birth control method All ethnies Heart failure patients with NYHA class &#8805; II symptoms EF<35% at echocardiography or MRI QRS duration >120 msec and/or echocardiographic evidence of mechanical dyssynchrony Optimal heart failure treatement Indication to CRT
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Praevious right ventricle electrical stimulation Praevious biventricular stimulation (recent explantation of device) Previous allergic reaction to any of the radiofarmaceuticals or excipients used in the study Chronic renal impairement requiring dialisis Recent myocardial infarction (< 1 month) or cerebrovascular event Pregnancy and lactation Severe thyroid dysorden

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: - To study cardiac sympathetic activity before and after CRT. - To study basal myocardial perfusion and systolic dyssynchrony derived parameters with nuclear cardiac imaging before and after CRT.;Secondary Objective: - To correlate data of myocardial perfusion, dyssynchrony and sympathetic activity, obtained before and after 4-6 months of CRT, with clinical and functional follow-up. - To correlate scintigraphic with echocardiographic parameters of dyssynchrony.;Primary end point(s): Basal myocardial perfusion, systolic dyssynchrony and sympathetic activity after 4-6 months of CRT, evaluated with nuclear imaging.