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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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cardiovascular Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Heart Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on November 25, 2014