Heart FailureADRECARDNCT02515812
Comparative Study of Cardiac Adrenergic Function Explored by I-123-MIBG and CZT Camera (D-SPECT) Versus Anger Camera in Patients With Heart Failure
A study testing I-123-MIBG, CZT Camera (D-SPECT) and Anger Camera in people with Heart Failure, run by University Hospital, Caen at 1 site in France.
Trial summary
Cardiological examination constitute one of the major directions in nuclear medicine for detection of myocardial ischemia in patients suspected of coronary disease. In Caen, they constitute 20% of the activity of nuclear medicine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- I-123-MIBG, CZT Camera (D-SPECT) and Anger Camera
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2012to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age above 18 years (except major patients under guardianship)
- patient who signed the consent form
- written and spoken French
- Beneficiaries of the social security system
- Stable heart failure with LV dysfunction (<45%) of ischemic or nonischemic origin
Who cannot join
- Patients with a recent history (<21 days) acute coronary failure (myocardial infarction, unstable angina)
- Patients with severe extra-cardiac disease may interfere with treatment decisions (cancer, severe hepatic or renal impairment)
- Major patients under guardianship
- Pregnant or lactating women
- Women in age and condition of childbearing
- Patients unable to understand the purpose of the study
Trial locations and contacts
1 site in 1 country.
About this study
Cardiological examination constitute one of the major directions in nuclear medicine for detection of myocardial ischemia in patients suspected of coronary disease. In Caen, they constitute 20% of the activity of nuclear medicine. Systolic heart failure (HF) ischemic or nonischemic origin represents a new area of activity of the nuclear cardiology. This is HF stratification study based on cardiac adrenergic function after injection of a tracer: I-123-MIBG. The team Caen nuclear cardiology is one of two teams recognized internationally in the field of evaluating the cardiac sympathetic innervation in cardiomyopathies. Numerous publications from 1992 to the present day have reported encouraging results for the daily use of this tracer in the evaluation of patients with LV dysfunction IC. Recently, interest in using the MIBG has been shown as a prognostic marker of HF in a prospective study of 961 patients. Typically, the camera used was an Anger camera with collimating Nai standard called parallel holes.
The main objective is to validate the measurements of cardiac adrenergic function evaluated by cardiopulmonary mediastinal reports and sympathetic innervation scores VG after injection of I-123-MIBG in 80 patients with heart failure.
- Conditions
- Heart Failure
- Being tested
- I-123-MIBG, CZT Camera (D-SPECT), Anger Camera
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-123-MIBGDrug
CZT Camera (D-SPECT)Device
Anger CameraDevice
| Study group | Role | What they receive |
|---|---|---|
| Adrenergic Function Explorations with CZT camera | Experimental | I-123-MIBG and CZT Camera (D-SPECT) Receives: Drug: I-123-MIBG; Device: CZT Camera (D-SPECT) |
| Adrenergic Function Explorations with Anger camera | Active comparator | I-123-MIBG and Anger Camera Receives: Drug: I-123-MIBG; Device: Anger Camera |
What is being measured
The primary outcome is the main question the study is designed to answer.
SRSI (summed rest score innervation)
with CZT camera and Anger camera
Measured: 4 hours after I-123-MIBG perfusion
SRS (summed rest score)
with CZT camera and Anger camera
Measured: 4 hours after I-123-MIBG perfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2015 (estimated)
- Study startOct 2012
- Primary completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02515812
- Sponsor's protocol ID
- 10-075
- Acronym
- ADRECARD
- Status last verified
- Aug 2015
- First submitted
- 28 Jul 2015
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Bellevre D, Manrique A, Legallois D, Bross S, Baavour R, Roth N, Blaire T, Desmonts C, Bailliez A, Agostini D. First determination of the heart-to-mediastinum ratio using cardiac dual isotope ((1)(2)(3)I-MIBG/(9)(9)mTc-tetrofosmin) CZT imaging in patients with heart failure: the ADRECARD study. Eur J Nucl Med Mol Imaging. 2015 Nov;42(12):1912-9. doi: 10.1007/s00259-015-3141-3. Epub 2015 Jul 31.
PubMed 26227533
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Cardiac Adrenergic Function Explored by I-123-MIBG and CZT Camera (D-SPECT) Versus Anger Camera in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT02515812
- Acronym / sponsor ID
- ADRECARD / 10-075
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Mar 2014 (actual)
- First posted
- 5 Aug 2015 (estimated)
- 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.
Cardiological examination constitute one of the major directions in nuclear medicine for detection of myocardial ischemia in patients suspected of coronary disease. In Caen, they constitute 20% of the activity of nuclear medicine. Systolic heart failure (HF) ischemic or nonischemic origin represents a new area of activity of the nuclear cardiology. This is HF stratification study based on cardiac adrenergic function after injection of a tracer: I-123-MIBG. The team Caen nuclear cardiology is one of two teams recognized internationally in the field of evaluating the cardiac sympathetic innervation in cardiomyopathies. Numerous publications from 1992 to the present day have reported encouraging results for the daily use of this tracer in the evaluation of patients with LV dysfunction IC. Recently, interest in using the MIBG has been shown as a prognostic marker of HF in a prospective study of 961 patients. Typically, the camera used was an Anger camera with collimating Nai standard called parallel holes.
The main objective is to validate the measurements of cardiac adrenergic function evaluated by cardiopulmonary mediastinal reports and sympathetic innervation scores VG after injection of I-123-MIBG in 80 patients with heart failure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adrenergic Function Explorations with CZT camera | Experimental | Drug: I-123-MIBG, Device: CZT Camera (D-SPECT)I-123-MIBG and CZT Camera (D-SPECT) |
| Adrenergic Function Explorations with Anger camera | Active comparator | Drug: I-123-MIBG, Device: Anger CameraI-123-MIBG and Anger Camera |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age above 18 years (except major patients under guardianship)
- patient who signed the consent form
- written and spoken French
- Beneficiaries of the social security system
- Stable heart failure with LV dysfunction (<45%) of ischemic or nonischemic origin
Key exclusion criteria (6 listed)
- Patients with a recent history (<21 days) acute coronary failure (myocardial infarction, unstable angina)
- Patients with severe extra-cardiac disease may interfere with treatment decisions (cancer, severe hepatic or renal impairment)
- Major patients under guardianship
- Pregnant or lactating women
- Women in age and condition of childbearing
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 |
|---|---|---|
| I-123-MIBG | Drug | Adrenergic Function Explorations with Anger camera, Adrenergic Function Explorations with CZT camera |
| CZT Camera (D-SPECT) | Device | Adrenergic Function Explorations with CZT camera |
| Anger Camera | Device | Adrenergic Function Explorations with Anger camera |
Primary outcome
SRSI (summed rest score innervation)
Time frame: 4 hours after I-123-MIBG perfusion
with CZT camera and Anger camera
SRS (summed rest score)
Time frame: 4 hours after I-123-MIBG perfusion
with CZT camera and Anger camera
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Results publication: PubMed 26227533Bellevre D, Manrique A, Legallois D, Bross S, Baavour R, Roth N, Blaire T, Desmonts C, Bailliez A, Agostini D. First determination of the heart-to-mediastinum ratio using cardiac dual isotope ((1)(2)(3)I-MIBG/(9)(9)mTc-tetrofosmin) CZT imaging in patients with heart failure: the ADRECARD study. Eur J Nucl Med Mol Imaging. 2015 Nov;42(12):1912-9. doi: 10.1007/s00259-015-3141-3. Epub 2015 Jul 31.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I-123-MIBG, CZT Camera (D-SPECT) and Anger Camera in people with Heart Failure, run by University Hospital, Caen at 1 site in France.
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 6 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: finished, as of the sponsor's last update on 2 Apr 2026. 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 France. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
SRSI (summed rest score innervation) (time frame: 4 hours after I-123-MIBG perfusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02515812, which also lists 1 linked publication.
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 Apr 2026.