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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-006666-28-IT
Enrollment
Unknown
Registered
2009-04-01
Start date
2009-04-24
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure MedDRA version: 9.1 Level: SOC Classification code 10007541 MedDRA version: 9.1 Level: SOC Classification code 10007541 MedDRA version: 9.1 Level: HLT Classification code 10007635 MedDRA version: 9.1 Level: HLT Classification code 10007635

Interventions

Trade Name: 123I-MIBG Pharmaceutical Form: Solution for injection Concentration unit: MBq/ml megabecquerel(s)/millilitre Concentration type: equal Concentration number: 74- Trade Name: MYOVIEW Pharma

Sponsors

AZIENDA OSPEDALIERA PISANA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Age >18 yrs and 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

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

Design outcomes

Primary

MeasureTime frame
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.—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026