NCT01085175

Trial to Determine Imaging Parameters of LMI1195 in Heart Failure Patients at Low and High Risk of Defibrillator Firing

A Multicenter, Phase II, Open Label Trial to Determine Optimal Imaging Parameters and Assess the Safety of LMI 1195 in Low Risk Patients and Heart Failure Patients With a History of Firing of an Implantable Cardioverter-Defibrillator

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Lantheus Medical Imaging · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical study is to determine the optimal imaging parameters and assess the safety of LMI1195 -101 in Heart Failure subjects at Low and High Risk of cardiac events.

Detailed description

* To determine the optimal imaging protocol for a single dose of LMI1195 during positron emission tomography (PET) for the intended study population. * To assess the safety and tolerability of LMI1195 in patients at low risk of ventricular arrhythmia ("low risk patients") and heart failure patients with a history of firing of an implantable cardioverter defibrillator (ICD) within 6 months prior to enrollment, a documented ejection fraction (EF) ≤ 35%, and a prior diagnosis of NYHA Class II-III heart failure ("heart failure patients") who are undergoing PET imaging.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DRUG	LMI 1195	Single bolus intravenous injection of LMI 1195

Timeline

• Start date: 2010-05-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2010-03-11
• Last updated: 2015-10-14

Locations

1 site across 1 country: United States