Ischemic CardiomyopathyPhase 2STB-XTR-003NCT07443696
PET Myocardial Fatty-acid Metabolic Imaging With XTR003 Injection and 18F-FDG to Assess Myocardial Viability in Ischemic Cardiomyopathy
A Phase 2 study testing Fasting XTR003/¹⁸F-FDG PET myocardial metabolic imaging and Glucose-loaded ¹⁸F-FDG PET Myocardial Metabolic Imaging in people with Ischemic Cardiomyopathy and Heart Failure, run by Sinotau Pharmaceutical Group at 3 sites in China.
Trial summary
This is a prospective, multicenter, randomized, open-label, parallel-controlled Phase IIb study to investigate the diagnostic-prognostic utility of XTR003 Injection integrated with 18F-FDG as an exploratory clinical trial. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ischemic Cardiomyopathy, Heart Failure
- What is being tested?
- Fasting XTR003/¹⁸F-FDG PET myocardial metabolic imaging and Glucose-loaded ¹⁸F-FDG PET Myocardial Metabolic Imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesChina
- Study dates
- 18 Dec 2025to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 85 years, regardless of gender.
- Diagnosed with ischemic cardiomyopathy (ICM).
- significant coronary artery disease (CAD).
- Left ventricular systolic dysfunction, with LVEF ranging from >20% to ≤40%
- Assessed by a team of cardiac surgeons/operators as suitable for complete revascularization.
- Capable of effective communication with the investigators, able to understand and comply with the clinical study requirements, voluntarily participate in the study, and provide written informed consent after being fully informed.
Who cannot join
- Decompensated heart failure within 48 hours prior to enrollment.
- Recent ST-segment elevation myocardial infarction (STEMI) within less than 4 weeks.
- Left ventricular aneurysm.
- Judged by the investigator as unable to complete PET examination.
- Severe renal insufficiency.
- Severe hepatic insufficiency.
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- Subjects with fever or active infectious diseases who are assessed by the investigator as unsuitable for study participation.
- Pregnant or lactating women.
- Contraindications to magnetic resonance imaging (MRI), such as claustrophobia or intracorporeal metallic implants.
- Subjects with mental disorders or poor compliance.
- Significant occupational exposure to ionizing radiation (e.g., exceeding 50 mSv per year) or exposure to radioactive substances/ionizing radiation for therapeutic or research purposes within the past 10 years.
- Other circumstances deemed by the investigator as unsuitable for trial participation.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality
Xu Ke Yang, +86-010-64426153, EC@anzhenGCP.com
- Not yet recruiting
Beijing Chaoyang Hospital, Capital Medical University
Beijing
- Not yet recruiting
TEDA International Cardiovascular Hospital
Tianjin
About this study
Official title: A Randomized, Open-Label, Parallel-Controlled Phase IIb Clinical Trial of PET Myocardial Fatty-acid Metabolic Imaging With XTR003 Injection Integrated With 18F-FDG for the Assessment of Myocardial Viability in Patients With Ischemic Cardiomyopathy
This is a prospective, multicenter, randomized, open-label, parallel-controlled Phase IIb study to investigate the diagnostic-prognostic utility of XTR003 Injection integrated with 18F-FDG as an exploratory clinical trial. A total of 40-60 patients will be enrolled and randomized into two study groups as: fasting XTR003/18F-FDG group and glucose-loaded group at a 1:1 ratio. Each group will receive resting myocardial perfusion imaging (MPI) combined with metabolic PET imaging to evaluate myocardial metabolic activity and myocardial viability. Segmental perfusion abnormality, metabolic activity and myocardial viability will be analyzed according to the standard approaches in Nuclear Cardiology. Regional and global left ventricular function will be assessed with cardiac MRI and echocardiography prior to and post the completion of full revascularization within 6-month time point. A repeated resting MPI will also be performed to assess the improvement of perfusion abnormality.
All study subjects will undergo 6 months follow-up for major adverse cardiac events (MACE).
- Conditions
- Ischemic Cardiomyopathy, Heart Failure
- Being tested
- Fasting XTR003/¹⁸F-FDG PET myocardial metabolic imaging, Glucose-loaded ¹⁸F-FDG PET Myocardial Metabolic Imaging
- Keywords
- 18F-FDG, XTR003, position emission tomography, myocardial metabolic imaging, myocardial viability, ischemic cardiomyopathy
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasting XTR003/¹⁸F-FDG PET myocardial metabolic imagingDrug
Fasting XTR003 / ¹⁸F-FDG PET myocardial metabolic imaging
Glucose-loaded ¹⁸F-FDG PET Myocardial Metabolic ImagingDrug
Glucose loaded ¹⁸F-FDG PET Myocardial Metabolic Imaging
| Study group | Role | What they receive |
|---|---|---|
| Fasting XTR003/ ¹⁸F-FDG PET | Experimental | Fasting XTR003 and ¹⁸F-FDG PET combined with myocardial metabolic imaging Receives: Drug: Fasting XTR003/¹⁸F-FDG PET myocardial metabolic imaging |
| Glucose-modulated ¹⁸F-FDG PET | Active comparator | Glucose-modulated ¹⁸F-FDG PET Myocardial Metabolic Imaging Receives: Drug: Glucose-loaded ¹⁸F-FDG PET Myocardial Metabolic Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
the sensitivity and specificity of the experimental group and control group
Using the recoverable left-ventricular wall motion abnormality at 6 months post full revascularization as the reference standard to study the sensitivity and specificity of myocardial viability for predicting functional recovery in the experimental group and control group.
Measured: 6 months
Secondary outcomes (11)
Myocardial perfusion-metabolism imaging parameters (segmental level)
include the following three items:
- summed rest score
- summed FDG score
- summed rest score minus summed FDG score
Measured: 6 months
Changes in left ventricular function parameters measured by cardiac magnetic resonance before and after revascularization
Left ventricular ejection fraction (LVEF, %)
Measured: 6 months
Changes in left ventricular function parameters measured by cardiac magnetic resonance before and after revascularization
Left ventricular end-diastolic diameter (LVEDD)
Measured: 6 months
Changes in left ventricular function parameters measured by cardiac magnetic resonance before and after revascularization
Left ventricular end-systolic diameter (LVESD)
Measured: 6 months
Changes in left ventricular function parameters measured by cardiac magnetic resonance before and after revascularization
Left ventricular end-diastolic volume (LVEDV, mL)
Measured: 6 months
Changes in left ventricular function parameters measured by cardiac magnetic resonance before and after revascularization
Left ventricular end-systolic volume (LVESV, mL)
Measured: 6 months
Changes in New York Heart Association Functional Classification (NYHA)
Measured: 6 months
Duration Required for PET Myocardial Metabolic Imaging in the Two Groups (min)
Measured: day 1
PET Myocardial Metabolic Imaging Quality
Measured: day 1
Resting MPI of perfusion abnormality
Measured: 6 months
Major adverse cardiac events (MACE)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start18 Dec 2025
- Primary completionAug 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic CardiomyopathyStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized and Open-Label
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinotau Pharmaceutical Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07443696
- Sponsor's protocol ID
- STB-XTR003-202
- Acronym
- STB-XTR-003
- Status last verified
- Feb 2026
- First submitted
- 24 Dec 2025
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Parallel-Controlled Phase IIb Clinical Trial of PET Myocardial Fatty-acid Metabolic Imaging With XTR003 Injection Integrated With 18F-FDG for the Assessment of Myocardial Viability in Patients With Ischemic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT07443696
- Acronym / sponsor ID
- STB-XTR-003 / STB-XTR003-202
- Conditions
- Ischemic Cardiomyopathy, Heart Failure
- Keywords
- 18F-FDG, XTR003, position emission tomography, myocardial metabolic imaging, myocardial viability, ischemic cardiomyopathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sinotau Pharmaceutical GroupIndustry (pharma, biotech, devices)
- Study start
- 18 Dec 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, multicenter, randomized, open-label, parallel-controlled Phase IIb study to investigate the diagnostic-prognostic utility of XTR003 Injection integrated with 18F-FDG as an exploratory clinical trial. A total of 40-60 patients will be enrolled and randomized into two study groups as: fasting XTR003/18F-FDG group and glucose-loaded group at a 1:1 ratio. Each group will receive resting myocardial perfusion imaging (MPI) combined with metabolic PET imaging to evaluate myocardial metabolic activity and myocardial viability. Segmental perfusion abnormality, metabolic activity and myocardial viability will be analyzed according to the standard approaches in Nuclear Cardiology. Regional and global left ventricular function will be assessed with cardiac MRI and echocardiography prior to and post the completion of full revascularization within 6-month time point. A repeated resting MPI will also be performed to assess the improvement of perfusion abnormality.
All study subjects will undergo 6 months follow-up for major adverse cardiac events (MACE).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized and Open-Label
| Arm | Type | Receives |
|---|---|---|
| Fasting XTR003/ ¹⁸F-FDG PET | Experimental | Drug: Fasting XTR003/¹⁸F-FDG PET myocardial metabolic imagingFasting XTR003 and ¹⁸F-FDG PET combined with myocardial metabolic imaging |
| Glucose-modulated ¹⁸F-FDG PET | Active comparator | Drug: Glucose-loaded ¹⁸F-FDG PET Myocardial Metabolic ImagingGlucose-modulated ¹⁸F-FDG PET Myocardial Metabolic Imaging |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 to 85 years, regardless of gender.
- Diagnosed with ischemic cardiomyopathy (ICM).
- significant coronary artery disease (CAD).
- Left ventricular systolic dysfunction, with LVEF ranging from >20% to ≤40%
- Assessed by a team of cardiac surgeons/operators as suitable for complete revascularization.
Key exclusion criteria (12 listed)
- Decompensated heart failure within 48 hours prior to enrollment.
- Recent ST-segment elevation myocardial infarction (STEMI) within less than 4 weeks.
- Left ventricular aneurysm.
- Judged by the investigator as unable to complete PET examination.
- Severe renal insufficiency.
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 |
|---|---|---|
| Fasting XTR003/¹⁸F-FDG PET myocardial metabolic imagingFasting XTR003 / ¹⁸F-FDG PET myocardial metabolic imaging | Drug | Fasting XTR003/ ¹⁸F-FDG PET |
| Glucose-loaded ¹⁸F-FDG PET Myocardial Metabolic ImagingGlucose loaded ¹⁸F-FDG PET Myocardial Metabolic Imaging | Drug | Glucose-modulated ¹⁸F-FDG PET |
Primary outcome
the sensitivity and specificity of the experimental group and control group
Time frame: 6 months
Using the recoverable left-ventricular wall motion abnormality at 6 months post full revascularization as the reference standard to study the sensitivity and specificity of myocardial viability for predicting functional recovery in the experimental group and control group.
11 secondary outcomes
Myocardial perfusion-metabolism imaging parameters (segmental level)
Time frame: 6 months
Changes in left ventricular function parameters measured by cardiac magnetic resonance before and after revascularization
Time frame: 6 months
Changes in left ventricular function parameters measured by cardiac magnetic resonance before and after revascularization
Time frame: 6 months
Changes in left ventricular function parameters measured by cardiac magnetic resonance before and after revascularization
Time frame: 6 months
Changes in left ventricular function parameters measured by cardiac magnetic resonance before and after revascularization
Time frame: 6 months
Changes in left ventricular function parameters measured by cardiac magnetic resonance before and after revascularization
Time frame: 6 months
Changes in New York Heart Association Functional Classification (NYHA)
Time frame: 6 months
Duration Required for PET Myocardial Metabolic Imaging in the Two Groups (min)
Time frame: day 1
PET Myocardial Metabolic Imaging Quality
Time frame: day 1
Resting MPI of perfusion abnormality
Time frame: 6 months
Major adverse cardiac events (MACE)
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Individual participant dataSharing planned: No
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fasting XTR003/¹⁸F-FDG PET myocardial metabolic imaging and Glucose-loaded ¹⁸F-FDG PET Myocardial Metabolic Imaging in people with Ischemic Cardiomyopathy and Heart Failure, run by Sinotau Pharmaceutical Group at 3 sites in China.
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 6 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tao Liu (+86-18101131863, tao.liu1@sinotau.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the sensitivity and specificity of the experimental group and control group (time frame: 6 months). 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 2 Mar 2026.