Trial Outcomes & Findings for Results of Tc99m-Maraciclatide Scintigraphy in Subjects With Diabetes Mellitus and Heart Failure With Preserved Left Ventricular Ejection Fraction (NCT NCT01440517)

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

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

Results posted on

2014-02-04

Participant Flow

Participant milestones

Participant milestones
Measure	Tc99m-Maraciclatide Injection The nominal activity of a single administration of Tc88m maraciclatide was 925 megabecquerels (MBq) (25 millicures).
Overall Study STARTED	5
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Tc99m-Maraciclatide Injection The nominal activity of a single administration of Tc88m maraciclatide was 925 megabecquerels (MBq) (25 millicures).
Overall Study Subject withdrawn prior to dosing	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tc99m-Maraciclatide Injection n=4 Participants The nominal activity of a single administration of Tc88m maraciclatide was 925 megabecquerels (MBq) (25 millicures).
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=99 Participants
Age, Categorical >=65 years	1 Participants n=99 Participants
Age, Continuous	63.5 years STANDARD_DEVIATION 4.2 • n=99 Participants
Sex: Female, Male Female	1 Participants n=99 Participants
Sex: Female, Male Male	3 Participants n=99 Participants
Region of Enrollment United States	4 participants n=99 Participants

PRIMARY outcome

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

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

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

Outcome measures

Outcome data not reported

SECONDARY outcome

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

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

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

Outcome measures

Outcome data not reported

Adverse Events

Tc99m-Maraciclatide Injection

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Tc99m-Maraciclatide Injection n=4 participants at risk The nominal activity of a single administration of Tc88m maraciclatide was 925 megabecquerels (MBq) (25 millicures).
Cardiac disorders Atrial Fibrillation	25.0% 1/4 • Number of events 1
Metabolism and nutrition disorders Diabetes Mellitus-Inadequate Control	25.0% 1/4 • Number of events 1

Additional Information

Arnold Jacobson, M.D.

GE Healthcare

Phone: 1-609-514-6325

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place