NL-OMON44945
Completed
Phase 3
AdreView* Myocardial Imaging for Risk Evaluation * A multicentre trial to guide ICD implantation in NYHA class II & III heart failure patients with 25% * LVEF * 35%. ADMIRE-ICD - ADMIRE-ICD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- heart failure
- Sponsor
- GE Healthcare AS
- Enrollment
- 42
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(1\) Patients \*18 years of age at the time dated informed consent is obtained.
- •(2\) Female patients must be pre\-menarchal, surgically sterile (had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (cessation of menses for more than 1 year), non\-lactating, or, if of childbearing potential, a serum or urine pregnancy test with the results known prior to AdreView\* (Iobenguane I123 Injection) administration) is negative.
- •(3\) Patients willing and able to comply with all study procedures and a signed and dated informed consent is obtained before any study\-procedure is carried out.
- •(4\) Heart failure NYHA class II or III for symptoms, patients with ischemic or non\-ischemic heart disease, eligible for ICD implantation as per each site\*s standard of practice.
- •(5\) Non\-ischemic dilated cardiomyopathy or ischemic heart disease of at least 3 months duration receiving guideline\-directed optimal medical therapy.
- •(6\) 25% \* LVEF \* 35%, performed within 3 months before or at time of enrolment, as measured by radionuclide ventriculography, or electrocardiogram \[ECG]\-gated SPECT myocardial perfusion imaging \[MPI], or magnetic resonance imaging \[MR], computed tomography \[CT], or 3D or 2D echocardiography \[Simpson\*s or multidisc method or equivalent only, M\-mode echocardiography is not accepted].
- •In case LVEF measurement is performed within 3 months before enrolment, measurement should be performed at least 40 days after a hospitalisation for HF or acute coronary syndrome (including myocardial infarction), and to be valid, method of measurement should be in accordance with the protocol and the imaging exam should be made available to the Sponsor in digital format.
- •In case several valid LVEF measurements are available, the closest to enrolment will be used for inclusion determination.
- •(7\) Clinically stable HF in the medical judgment of the investigator (i.e., no significant changes in medication, no worsening of symptoms, no unscheduled visits to the doctor\*s office) for the past 30 days and no hospitalisation for HF or acute coronary syndrome (including myocardial infarction) in the past 40 days.
- •(8\) Reasonable expectation of meaningful survival for at least 1 year.
Exclusion Criteria
- •(1\) Patients with existing ICD or patient having an indication of ICD implantation for secondary prevention of SCD.
- •(2\) Hospitalisation for HF or for acute coronary syndrome in the previous 40 days.
- •(3\) Patients where a cardiac resynchronisation therapy (CRT) is planned or indicated
- •(4\) Other indication for placement of device (sustained ventricular tachycardia, resuscitated sudden death, need for atrioventricular pacing).
- •(5\) NYHA class I or class IV symptoms at the time of study entry.
- •(6\) American College of Cardiology\-American Heart Association (ACC\-AHA) class III or class IV (unstable) angina.
- •(7\) Patient with chronic renal insufficiency defined as serum creatinine \* 3 mg/dl (or \* 265\.2 \*mol/L).
- •(8\) Known or suspected hypersensitivity/allergy to Iobenguane or to any of the excipients in AdreView\* (Iobenguane I123 Injection).
- •(9\) Patient who is pregnant or plans to become pregnant within 2 weeks after AdreView\* (Iobenguane I123 Injection) administration.
- •(10\) Patient who has used any medication in the 2 weeks before AdreView\* (Iobenguane I123 Injection) that could interfere with the test: e.g., but not limited to amitriptyline or derivatives, imipramine or derivatives, other antidepressants or drugs known or suspected to inhibit the norepinephrine transporter, antihypertensives that deplete norepinephrine stores or inhibit reuptake, sympathomimetic amines or cocaine.
Outcomes
Primary Outcomes
Not specified
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