Results of Tc99m-Maraciclatide Scintigraphy in Subjects With Diabetes Mellitus and Heart Failure With Preserved Left Ventricular Ejection Fraction

Study Overview
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Brief Summary
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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.

Official Title
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An Open-Label, Multicenter, Proof of Concept, Phase 2 Study Evaluating the Results of Tc99m-Maraciclatide Scintigraphy in Subjects With Diabetes Mellitus (DM) and Heart Failure With Preserved Left Ventricular Ejection Fraction (HFPEF)

Conditions
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Diabetes Mellitus, Heart Failure

Intervention / Treatment
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* Drug: Tc99m-Maraciclatide


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tc99m-Maraciclatide<br> | Drug: Tc99m-Maraciclatide<br>* Freeze-dried powder Kit for the preparation of Maraciclatide (99mTc) Injection<br>* Other names: Maraciclatide (99mTc) Injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of Active Myocardial Angiogenesis/Remodeling | Due to the lack of subject enrollment, efficacy data were not analyzed. | Time zero equals the date of contrast imaging and for up to 24 hours for safety monitoring post contrast administration. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 zero equals the date of contrast imaging and for up to 24 hours for safety monitoring post contrast administration. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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