Heart FailurePhase 2LMI1195-201NCT01085175
Trial to Determine Imaging Parameters of LMI1195 in Heart Failure Patients at Low and High Risk of Defibrillator Firing
A Phase 2 study testing LMI 1195 in people with Heart Failure, run by Lantheus Medical Imaging at 1 site in United States.
Trial summary
The purpose of this clinical study is to determine the optimal imaging parameters and assess the safety of LMI1195 -101 in Heart Failure subjects at Low and High Risk of cardiac events. 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?
- LMI 1195
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Feb 2011
- Phase
- Phase 2
- 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
- Male or non-pregnant female ≥ 18 years of age
- a body weight that is <450 pounds
- Be able to lie flat for at least 2-hour intervals
- Have a normal left ventricular ejection fraction (i.e., ≥ 55% for cohort one or ≤35% for cohort two) by multiple gate acquisition scan (MUGA), echocardiogram or single photon emission computed tomography (SPECT) within 90 days prior, but no less than 3 days prior to enrollment.
- Have been scheduled to undergo or have undergone a SPECT or an approved PET perfusion imaging study performed within 90 days prior to, but no less than 3 days prior to enrollment. to and within the study timeline must be reviewed and deemed acceptable by the judgment of the investigator) (Additional More Specific Criteria can be accessed by contacting an LMI representative)
Who cannot join
- Have a history of diabetes, coronary artery disease, myocardial infarction heart arrhythmia (except sinus arrhythmia), heart failure, cardiomyopathy (e.g. restrictive, infiltrative or hypertrophic cardiomyopathy), constrictive pericarditis, myocarditis, complex congenital disease, surgically correctable valvular disease, and/or inoperable, obstructive valvular disease, pacemaker, syncope, transient ischemic attack (TIA) or cerebrovascular accident (CVA), Parkinson's disease, degenerative cerebral disease, or organ transplantation.significant comorbid conditions
- Have undergone major surgery within 4 weeks prior to enrollment or planned within 3 weeks after completion of the study.
- Unexplained syncope within 5 years.
- A life expectancy of < 1 year, from any cause.
- Are currently participating in another clinical trial of an investigational product.
- Have clinically significant laboratory abnormalities (e.g., liver enzymes, creatinine, etc.).
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- Have a history of smoking within 1 month of enrollment.
- History of drug or alcohol abuse
- Have a history of major psychiatric disorder, active alcohol/drug abuse, and/or history of non-compliance.
- Receipt of any radiopharmaceutical within a period equal to 10 half-lives of the isotope (e.g., for 99mTc, a period of 60 hours; for 111In, a period of 28 days) prior to enrollment or receipt of any radiopharmaceutical containing iodine within a period of 3 months prior to enrollment.
- Have received any of the following medications within 30 days prior to enrollment, because of confounding effects to the autonomic nervous system: albuterol (Alupent, Ventolin within 24 hours), Dobutamine (Dobutrex), Dopamine (Intropin), Epinephrine (Adrenalin), Isoproterenol, Phenylephrine (Neo-Synephrine), Metaraminol (Aramine), Norepinephrine (Levophed), furazolidone (Furoxone), tricyclic antidepressants (Adapin, Asendin, Aventyl, Elavil, Endep, Norpramin, Pamelor, Sinequan, Surmontil, Tofranil, Vivactil), guanethidine (Ismelin), methyldopa (Aldomet). Over the counter herbs that have been reported to interact with adrenergic amines are excluded: ephedra (ma huang), St. John's wort; alfalfa; hibiscus; ginseng; angelica (dong quai); and yohimbe.
- Are not suitable subjects for completion of any screening or trial procedures including PET, scans \& laboratory testing,
- Receipt of any radiopharmaceutical within a period of time that the agent has not decayed below background levels
- Have metal that cannot be removed from the body located in the thorax, Receiving Class I or III antiarrhythmic drug therapy, except for amiodarone.
- (Additional More Specific Criteria can be accessed by contacting an LMI representative)
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical College
New York, New York, 10032
About this study
Official title: A Multicenter, Phase II, Open Label Trial to Determine Optimal Imaging Parameters and Assess the Safety of LMI 1195 in Low Risk Patients and Heart Failure Patients With a History of Firing of an Implantable Cardioverter-Defibrillator
The purpose of this clinical study is to determine the optimal imaging parameters and assess the safety of LMI1195 -101 in Heart Failure subjects at Low and High Risk of cardiac events.
Read the detailed description
- To determine the optimal imaging protocol for a single dose of LMI1195 during positron emission tomography (PET) for the intended study population.
- To assess the safety and tolerability of LMI1195 in patients at low risk of ventricular arrhythmia ("low risk patients") and heart failure patients with a history of firing of an implantable cardioverter defibrillator (ICD) within 6 months prior to enrollment, a documented ejection fraction (EF) ≤ 35%, and a prior diagnosis of NYHA Class II-III heart failure ("heart failure patients") who are undergoing PET imaging.
- Conditions
- Heart Failure
- Being tested
- LMI 1195
- Keywords
- Heart Failure,, PET Imaging,, Implantable Cardioverter-Defibrillator,, Sudden Cardiac Death
- Medical subject headings
- Heart Failure, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LMI 1195Drug
Also called LMI 1195-101 Clinical Trial
Single bolus intravenous injection of LMI 1195
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Low risk Heart Failure patients Receives: Drug: LMI 1195 |
| Cohort 2 | Experimental | High risk Heart Failure patients with history of Implantable Cardioverter-Defibrillator firing Receives: Drug: LMI 1195 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose acquisition time product, target and non-target F18 count density
Measured: Approximately one year
Secondary outcomes (1)
Assess Image Quality Data Variability across age & sex stratification Determine Retention Index Values Determine Heart to Mediastinal Ratio Evaluate additional image derived markers that may have predictive value
Measured: Approximately one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2010 (estimated)
- Study startMay 2010
- Primary completionFeb 2011 (estimated)
- Study completionFeb 2011 (estimated)
Why it stopped: Sponsor is re-evaluating the clinical development path
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lantheus Medical Imaging
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Veronica Lee, M.D., Study director, Lantheus Medical Imaging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01085175
- Sponsor's protocol ID
- LMI 1195-201
- Acronym
- LMI1195-201
- Status last verified
- Feb 2011
- First submitted
- 12 Feb 2010
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Phase II, Open Label Trial to Determine Optimal Imaging Parameters and Assess the Safety of LMI 1195 in Low Risk Patients and Heart Failure Patients With a History of Firing of an Implantable Cardioverter-Defibrillator
- ClinicalTrials.gov ID
- NCT01085175
- Acronym / sponsor ID
- LMI1195-201 / LMI 1195-201
- Conditions
- Heart Failure
- Keywords
- Heart Failure,, PET Imaging,, Implantable Cardioverter-Defibrillator,, Sudden Cardiac Death
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor is re-evaluating the clinical development path
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Lantheus Medical ImagingIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Feb 2011 (estimated)
- Study completion
- Feb 2011 (estimated)
- First posted
- 11 Mar 2010 (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.
The purpose of this clinical study is to determine the optimal imaging parameters and assess the safety of LMI1195 -101 in Heart Failure subjects at Low and High Risk of cardiac events.
Detailed description
- To determine the optimal imaging protocol for a single dose of LMI1195 during positron emission tomography (PET) for the intended study population.
- To assess the safety and tolerability of LMI1195 in patients at low risk of ventricular arrhythmia ("low risk patients") and heart failure patients with a history of firing of an implantable cardioverter defibrillator (ICD) within 6 months prior to enrollment, a documented ejection fraction (EF) ≤ 35%, and a prior diagnosis of NYHA Class II-III heart failure ("heart failure patients") who are undergoing PET imaging.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: LMI 1195Low risk Heart Failure patients |
| Cohort 2 | Experimental | Drug: LMI 1195High risk Heart Failure patients with history of Implantable Cardioverter-Defibrillator firing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or non-pregnant female ≥ 18 years of age
- a body weight that is <450 pounds
- Be able to lie flat for at least 2-hour intervals
- Have a normal left ventricular ejection fraction (i.e., ≥ 55% for cohort one or ≤35% for cohort two) by multiple gate acquisition scan (MUGA), echocardiogram or single photon emission computed tomography (SPECT) within 90 days prior, but no less than 3 days prior to enrollment.
- Have been scheduled to undergo or have undergone a SPECT or an approved PET perfusion imaging study performed within 90 days prior to, but no less than 3 days prior to enrollment. to and within the study timeline must be reviewed and deemed acceptable by the judgment of the investigator) (Additional More Specific Criteria can be accessed by contacting an LMI representative)
Key exclusion criteria (15 listed)
- Have a history of diabetes, coronary artery disease, myocardial infarction heart arrhythmia (except sinus arrhythmia), heart failure, cardiomyopathy (e.g. restrictive, infiltrative or hypertrophic cardiomyopathy), constrictive pericarditis, myocarditis, complex congenital disease, surgically correctable valvular disease, and/or inoperable, obstructive valvular disease, pacemaker, syncope, transient ischemic attack (TIA) or cerebrovascular accident (CVA), Parkinson's disease, degenerative cerebral disease, or organ transplantation.significant comorbid conditions
- Have undergone major surgery within 4 weeks prior to enrollment or planned within 3 weeks after completion of the study.
- Unexplained syncope within 5 years.
- A life expectancy of < 1 year, from any cause.
- Are currently participating in another clinical trial of an investigational product.
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 |
|---|---|---|
| LMI 1195Also: LMI 1195-101 Clinical TrialSingle bolus intravenous injection of LMI 1195 | Drug | Cohort 1, Cohort 2 |
Primary outcome
Dose acquisition time product, target and non-target F18 count density
Time frame: Approximately one year
1 secondary outcome
Assess Image Quality Data Variability across age & sex stratification Determine Retention Index Values Determine Heart to Mediastinal Ratio Evaluate additional image derived markers that may have predictive value
Time frame: Approximately one year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
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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.
Veronica Lee, M.D. study director
Lantheus Medical Imaging
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 LMI 1195 in people with Heart Failure, run by Lantheus Medical Imaging 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 15 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: withdrawn, as of the sponsor's last update on 14 Oct 2015. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Dose acquisition time product, target and non-target F18 count density (time frame: Approximately one year). 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 14 Oct 2015.