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

Heart Failure Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01440517
• Other study ID #: GE-078-101
• Status: Terminated
• Phase: Phase 2
• First received: September 22, 2011
• Last updated: January 2, 2014
• Start date: August 2011
• Est. completion date: March 2012

Study information

• Verified date: January 2014
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetes Mellitus
• Heart Failure

Intervention

Drug:
• Tc99m-Maraciclatide
Freeze-dried powder Kit for the preparation of Maraciclatide (99mTc) Injection

Locations

Country	Name	City	State
United States	GE Healthcare	Princeton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
GE Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
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 zero equals the date of contrast imaging and for up to 24 hours for safety monitoring post contrast administration.	No