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

This study has been terminated.
(Lack of Subject Recruitment)
Sponsor:
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT01440517
First received: September 22, 2011
Last updated: January 2, 2014
Last verified: January 2014

September 22, 2011
January 2, 2014
August 2011
March 2012   (final data collection date for primary outcome measure)
Evidence of Active Myocardial Angiogenesis/Remodeling [ Time Frame: Time zero equals the date of contrast imaging and for up to 24 hours for safety monitoring post contrast administration. ] [ Designated as safety issue: No ]
Due to the lack of subject enrollment, efficacy data were not analyzed.
Evidence of active myocardial angiogenesis/remodeling [ Time Frame: Time zero equals the date of contrast imaging and for up to 24 hours for safety monitoring post contrast administration. ] [ Designated as safety issue: No ]
To determine if there is evidence of active myocardial angiogenesis/remodeling (as reflected by increased 99mTc-maraciclatide uptake) in subjects with DM and HFPEF (LVEF ≥45%).
Complete list of historical versions of study NCT01440517 on ClinicalTrials.gov Archive Site
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 Frame: Time zero equals the date of contrast imaging and for up to 24 hours for safety monitoring post contrast administration. ] [ Designated as safety issue: No ]
Due to the lack of subject enrollment, efficacy data were not analyzed.
Compare 99mTc-maraciclatide uptake [ Time Frame: Time zero equals the date of contrast imaging and for up to 24 hours for safety monitoring post contrast administration. ] [ Designated as safety issue: No ]
To compare 99mTc-maraciclatide uptake in diabetic subjects with HFPEF (LVEF ≥45%) to that of subjects with DM and asymptomatic diastolic dysfunction.
Not Provided
Not Provided
 
Results of Tc99m-Maraciclatide Scintigraphy in Subjects With Diabetes Mellitus and Heart Failure With Preserved Left Ventricular Ejection Fraction
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)

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Diabetes Mellitus
  • Heart Failure
Drug: Tc99m-Maraciclatide
Freeze-dried powder Kit for the preparation of Maraciclatide (99mTc) Injection
Other Name: Maraciclatide (99mTc) Injection
Experimental: Tc99m-Maraciclatide
Intervention: Drug: Tc99m-Maraciclatide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4
March 2012
March 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01440517
GE-078-101
No
GE Healthcare
GE Healthcare
Not Provided
Study Director: Arnold Jacobson, MD GE Healthcare
GE Healthcare
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP