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
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus
Heart Failure
Drug: Tc99m-Maraciclatide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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)

Resource links provided by NLM:


Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 4
Study Start Date: August 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tc99m-Maraciclatide Drug: Tc99m-Maraciclatide
Freeze-dried powder Kit for the preparation of Maraciclatide (99mTc) Injection
Other Name: Maraciclatide (99mTc) Injection

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01440517

Locations
United States, New Jersey
GE Healthcare
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
GE Healthcare
Investigators
Study Director: Arnold Jacobson, MD GE Healthcare
  More Information

No publications provided

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01440517     History of Changes
Other Study ID Numbers: GE-078-101
Study First Received: September 22, 2011
Results First Received: August 30, 2013
Last Updated: January 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by GE Healthcare:
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

Additional relevant MeSH terms:
Diabetes Mellitus
Heart Failure
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014