Diabetes Mellitus, Heart Failure
Conditions
Keywords
CE-MRI - Contrast-enhanced magnetic resonance imaging, DM - Diabetes mellitus, EKG - Echocardiography, HFPEF - Heart failure preserved left ventricular ejection fraction, LVEF - Left Ventricular Ejection Fraction
Brief summary
The purpose of this study is to evaluate the results of 99mTc maraciclatide scintigraphy in diabetic subjects with HFPEF. A maximum of 20 subjects with Diabetes Mellitus (DM) and Heart Failure With Preserved Left Ventricular Ejection Fraction (HFPEF) will be enrolled and imaged with 99mTc maraciclatide. In addition, a maximum of 10 subjects with DM and diastolic dysfunction but no diagnosis of heart failure (HF) will be enrolled and imaged with 99mTc-maraciclatide.
Interventions
DRUGTc99m-Maraciclatide
Freeze-dried powder Kit for the preparation of Maraciclatide (99mTc) Injection
Sponsors
GE Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* The subject is between 18 and 80 years of age. * The subject was diagnosed with DM type 2 based upon accepted clinical criteria and currently takes at least one diabetes medication. * For HF subjects: The subject was diagnosed with HF with preserved EF within the previous 1 year, at which time LVEF was determined to be ≥45%. * For comparison subjects: The subject was determined to have diastolic dysfunction on EKG within the previous year and currently has no signs or symptoms of HF. * The subject has been clinically stable for at least 7 days prior to the study imaging procedures (e.g., not experiencing continuing chest pain, hemodynamic instability, worsening HF symptoms, or clinically significant arrhythmia).
Exclusion criteria
* The subject had an acute myocardial infarction within the past 30 days. * The subject had a cardiac revascularization (e.g., percutaneous transluminal coronary angiography \[PTCA\], percutaneous coronary intervention (PCI), or coronary artery bypass graft \[CABG\]) within the past 30 days. * The subject has severe renal dysfunction. * The subject is claustrophobic or has a movement disorder that prevents him/her from lying still in a supine position for up to 20 minutes at a time. * The subject has participated in a research study using ionizing radiation in the previous 12 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evidence of Active Myocardial Angiogenesis/Remodeling | Time zero equals the date of contrast imaging and for up to 24 hours for safety monitoring post contrast administration. | Due to the lack of subject enrollment, efficacy data were not analyzed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Uptake of 99mTc-maraciclatide Agent in Diabetic Subjects With Heart Failure With Preserved Left Ventricular Fraction and Subjects With Diabetes Mellitus and Asymptomatic Diastolic Dysfunction | Time zero equals the date of contrast imaging and for up to 24 hours for safety monitoring post contrast administration. | Due to the lack of subject enrollment, efficacy data were not analyzed. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tc99m-Maraciclatide Injection The nominal activity of a single administration of Tc88m maraciclatide was 925 megabecquerels (MBq) (25 millicures). | 4 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Subject withdrawn prior to dosing | 1 |
Baseline characteristics
| Characteristic | Tc99m-Maraciclatide Injection |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Age, Continuous | 63.5 years STANDARD_DEVIATION 4.2 |
| Region of Enrollment United States | 4 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
Primary
Evidence of Active Myocardial Angiogenesis/Remodeling
Due to the lack of subject enrollment, efficacy data were not analyzed.
Time frame: Time zero equals the date of contrast imaging and for up to 24 hours for safety monitoring post contrast administration.
Population: Due to the lack of subject enrollment, efficacy data were not analyzed.
Secondary
Uptake of 99mTc-maraciclatide Agent in Diabetic Subjects With Heart Failure With Preserved Left Ventricular Fraction and Subjects With Diabetes Mellitus and Asymptomatic Diastolic Dysfunction
Due to the lack of subject enrollment, efficacy data were not analyzed.
Time frame: Time zero equals the date of contrast imaging and for up to 24 hours for safety monitoring post contrast administration.
Population: Due to the lack of subject enrollment, efficacy data were not analyzed.