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

NCT01440517 | Terminated Phase 2 Results

• 1 other identifier: GE-078-101
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• 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 zero equals the date of contrast imaging and for up to 24 hours for safety monitoring post contrast administration.

Study Arms (1)

Tc99m-Maraciclatide

EXPERIMENTAL

Drug: Tc99m-Maraciclatide

Interventions

Tc99m-Maraciclatide DRUG

Freeze-dried powder Kit for the preparation of Maraciclatide (99mTc) Injection

Also known as: Maraciclatide (99mTc) Injection

Tc99m-Maraciclatide

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• GE Healthcare: lead

Study Sites (1)

GE Healthcare

Princeton, New Jersey, 08540, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Heart Failure

Interventions

NC100692; Injections

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Arnold Jacobson, M.D.
• Organization: GE Healthcare

Arnold.Jacobson@ge.com

1-609-514-6325

Study Officials

• Arnold Jacobson, MD

  GE Healthcare

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2011
• First Posted: September 26, 2011
• Study Start: August 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: February 4, 2014
• Results First Posted: February 4, 2014

Record last verified: 2014-01

Locations

US (1)