Heart Failure
Conditions
Keywords
Heart Failure, PET Imaging, Implantable Cardioverter-Defibrillator, Dosimetry
Brief summary
The purpose of this clinical study is to estimate the safety and radiation dosimetry of a single dose of LMI1195 in healthy subjects and heart failure patients undergoing positron emission tomography (PET)
Interventions
DRUGLMI 1195-101
Single dose, bolus IV injection of LMI 1195
Sponsors
Lantheus Medical Imaging
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
Cohort 1 Inclusion: * Healthy, age 18-40 Cohort 1 Exclusion: * Significant or chronic medical illness * Pregnant females * Smoking within one month of enrollment * Use of any prescription drugs within 4 weeks prior to dosing Cohort 2 Inclusion: * 30-70 year old subjects with a diagnosis of NYHA Class II-III heart failure * Ejection fraction less than or equal to 35% * Rest SPECT imaging within 90 days prior to enrollment Cohort 2 Exclusion: * Significant or chronic medical illness * Pregnant females * Known history of arrhythmogenic disorder or rhythm disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of LMI 1195 in terms of treatment-related adverse events | 14 days | Number of study subjects exhibiting treatment-related adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiation Dosimetry of a single dose of LMI 1195 | 2 days | Radiation dose to organs defined by the MIRD model, in mGy/MBq |
Countries
United States
Outcome results
None listed