Diabetes MellitusPhase 2NCT01440517
Results of Tc99m-Maraciclatide Scintigraphy in Subjects With Diabetes Mellitus and Heart Failure With Preserved Left Ventricular Ejection Fraction
A Phase 2 study testing Tc99m-Maraciclatide in people with Diabetes Mellitus and Heart Failure, run by GE Healthcare at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Heart Failure
- What is being tested?
- Tc99m-Maraciclatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Mar 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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
- Being tested
- Tc99m-Maraciclatide
- 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
- Medical subject headings
- Diabetes Mellitus, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tc99m-MaraciclatideDrug
Also called Maraciclatide (99mTc) Injection
Freeze-dried powder Kit for the preparation of Maraciclatide (99mTc) Injection
| Study group | Role | What they receive |
|---|---|---|
| Tc99m-Maraciclatide | Experimental | Not described Receives: Drug: Tc99m-Maraciclatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of Active Myocardial Angiogenesis/Remodeling
Due to the lack of subject enrollment, efficacy data were not analyzed.
Measured: 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
Due to the lack of subject enrollment, efficacy data were not analyzed.
Measured: Time zero equals the date of contrast imaging and for up to 24 hours for safety monitoring post contrast administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2011 (estimated)
- Study startAug 2011
- Primary completionMar 2012
- Study completionMar 2012
Why it stopped: Lack of Subject Recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arnold Jacobson, MD, Study director, GE Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01440517
- Sponsor's protocol ID
- GE-078-101
- Status last verified
- Jan 2014
- First submitted
- 22 Sep 2011
- Last updated
- 4 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01440517
- Acronym / sponsor ID
- GE-078-101
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of Subject Recruitment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 26 Sep 2011 (estimated)
- Results
- Posted 4 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tc99m-Maraciclatide | Experimental | Drug: Tc99m-Maraciclatide |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tc99m-MaraciclatideAlso: Maraciclatide (99mTc) InjectionFreeze-dried powder Kit for the preparation of Maraciclatide (99mTc) Injection | Drug | Tc99m-Maraciclatide |
Primary outcome
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.
Due to the lack of subject enrollment, efficacy data were not analyzed.
1 secondary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnold Jacobson, MD study director
GE Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tc99m-Maraciclatide in people with Diabetes Mellitus and Heart Failure, run by GE Healthcare at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2014.