Clinical trial NCT01440517: Results of Tc99m-Maraciclatide Scintigraphy in Subjects With Diabetes Mellitus and Heart Failure With Preserved Left Ventricular Ejection Fraction
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Diabetes Mellitus
Heart Failure
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
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2011-09-26
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Evidence of Active Myocardial Angiogenesis/Remodeling
timeFrame: Time zero equals the date of contrast imaging and for up to 24 hours for safety monitoring post contrast administration.
Secondary outcomes:
measure: 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
timeFrame: Time zero equals the date of contrast imaging and for up to 24 hours for safety monitoring post contrast administration.
Other outcomes:
Locations:
city: Princeton
country: United States
facility: GE Healthcare
state: New Jersey
Study officials:
affiliation: GE Healthcare
name: Arnold Jacobson, MD
role: STUDY_DIRECTOR
References: