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

Primary Purpose

Diabetes Mellitus, Heart Failure

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Tc99m-Maraciclatide

About this trial

This is an interventional diagnostic trial for Diabetes Mellitus focused on measuring 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

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

GE Healthcare

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tc99m-Maraciclatide

Arm Description

Outcomes

Primary Outcome Measures

Evidence of Active Myocardial Angiogenesis/Remodeling

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

Due to the lack of subject enrollment, efficacy data were not analyzed.

Full Information

NCT ID

NCT01440517

First Posted

September 22, 2011

Last Updated

January 2, 2014

Sponsor

GE Healthcare

1. Study Identification

Unique Protocol Identification Number

NCT01440517

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Terminated

Why Stopped

Lack of Subject Recruitment

Study Start Date

August 2011 (undefined)

Primary Completion Date

March 2012 (Actual)

Study Completion Date

March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GE Healthcare

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tc99m-Maraciclatide

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Tc99m-Maraciclatide

Other Intervention Name(s)

Maraciclatide (99mTc) Injection

Intervention Description

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

Primary Outcome Measure Information:

Title

Evidence of Active Myocardial Angiogenesis/Remodeling

Description

Due to the lack of subject enrollment, efficacy data were not analyzed.

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

Due to the lack of subject enrollment, efficacy data were not analyzed.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Arnold Jacobson, MD

Organizational Affiliation

GE Healthcare

Official's Role

Study Director

Facility Information:

Facility Name

GE Healthcare

City

Princeton

State/Province

New Jersey

ZIP/Postal Code

08540

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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