A Phase 3 Multinational Randomized Placebo-controlled Study of ARRY-371797 in Patients with Symptomatic Dilated Cardiomyopathy Due to a Lamin A/C Gene Mutation
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: Chf
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Age: Between 18 years - 120 years
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Gender: Male or Female
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Other Inclusion Criteria:
Prescreening for Patients with Pre-identified Deleterious LMNA Mutations:- Subjects provide a signed and dated informed consent document
- Subjects are at least 18 years old
- Subjects with NYHA functional Class II, III or IV
- Subjects have an ICD or CRT-D
- Subjects with at least one eye meeting all eligible eye inclusion criteria and no exclusion criteria
- Subjects have symptomatic DCM with pre-identified deleterious LMNA mutation
- Subjects have no documented history of a clinical illness or condition other than LMNA mutations that is associated with HF or, in the judgment of the Investigator, would make the patient inappropriate for study participation.
- Subjects who are affiliated to a social security system, or is a beneficiary
- Subjects provide a signed and dated informed consent document
- Subjects are at least 18 years old
- Subjects with NYHA functional Class II, III or IV
- Subjects have an ICD or CRT-D
- Subjects who will have a history of reduced EF and at least one of the following:
- Atrioventricular conduction block of at least first degree
- Family history of early onset HF/arrhythmia consistent with a diagnosis of idiopathic DCM.
- History of paroxysmal or sustained atrial arrhythmia, including atrial fibrillation, atrial flutter or supraventricular tachycardia.
- Subjects have no documented history of a clinical illness or condition other than LMNA mutations that is associated with HF or, in the judgment of the Investigator, would make the patient inappropriate for study participation.
- Subjects who are affiliated to a social security system, or is a beneficiary
- Subjects provide a signed and dated informed consent document
- Subjects are at least 18 years old
- Subjects who symptomatic LMNA-related DCM as per the protocol
- Subjects have an ICD or CRT-D
- Subjects with objective functional impairment evidenced by a reduction in 6MWT as per the protocol
- Subjects with impaired function due to symptomatic DCM rather than any noncardiac comorbidity that can significantly impair function
- Subjects with stable medical and/or device therapy consistent with American Heart Association (AHA) / American College of Cardiology (ACC) or European Society of Cardiology (ESC) guidelines, without change in HF drug(s) dose in the past 1 month
- Subjects have acceptable hematology, hepatic and renal function laboratory values as per the protocol
- Female subjects of childbearing potential must have a negative serum betahumanchorionic gonadotropin (ß-HCG) test within 7 to 35 days prior to Day 1 and consent to ongoing urine pregnancy testing during the course of the study.
- Male subjects and female subjects of childbearing potential must agree to use a highly effective method of contraception as defined in the study protocol
- Subjects willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
- Subjects who are affiliated to a social security system, or is a beneficiary
You may not be eligible for this study if the following are true:
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- Subjects with presence of other form(s) of cardiomyopathy contributing to HF or clinically significant cardiac anatomic abnormality.
- Subjects with clinically significant coronary artery disease
- Subjects with presence of a ventricular assist device or history of prior heart transplantation
- Subjects with uncorrected, hemodynamically significant (i.e., moderate-severe) primary structural valvular disease not due to HF
- Subjects currently receiving or deemed at high risk of requiring chronic renal replacement therapy (e.g., hemodialysis or peritoneal dialysis) within 6 months
- Subjects who have treatment with any investigational agent(s) for HF at the open-label Baseline Visit
- Subjects with malignancy that is active or has been diagnosed within 3 years prior to screening
- Subjects with Non-cardiac condition that limits lifespan to < 1 year
- Subjects with medical, psychiatric, cognitive or other conditions that compromise the patient's ability to understand the patient information, comply with the study protocol or complete the study
- Subjects with any severe concurrent disease or condition
- Subjects who are pregnant or breastfeeding, or patients who plan to become pregnant during the duration of the trial
- Subjects with documented hypersensitivity/allergy or clinically significant intolerance to any component of drug product
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.