Loading clinical trials...

Results of Tc99m-Maraciclatide Scintigraphy in Subjects With Diabetes Mellitus and Heart Failure With Preserved Left Ventricular Ejection Fraction | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

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)

NCT01440517•GE Healthcare

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 80 years

Sex

ALL

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.

Locations (1)

GE Healthcare

Princeton, New Jersey, United States

Key Dates

Start Date

August 1, 2011

Primary Completion Date

March 1, 2012

Completion Date

March 1, 2012

Last Updated

February 4, 2014

Enrollment

ACTUAL participants

Conditions

Diabetes MellitusHeart Failure

Interventions

Tc99m-Maraciclatide

DRUG

Genetic Studies of Insulin and Diabetes

NCT00001987

Diabetes MellitusSevere Insulin Resistance

View study

RECRUITINGNA

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 4, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Genetic Studies of Insulin and Diabetes

Feasibility of a Tailored Online Self-compassion Intervention

ReDS-guided Decongestion Strategy in Patients Hospitalized for Heart Failure

ML Score Prediction of Cardiotoxicity in Cancer Patients Receiving Anthracycline Chemotherapy or HER2-Targeted Therapies

Mesenchymal Stem Cell and Exosome Therapy for Diabetic Erectile Dysfunction

A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes