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:

  • Conditions:
    Chf
  • Age: Between 18 - 120 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    Prescreening for Patients with Pre-identified Deleterious LMNA Mutations:
    1. Subjects provide a signed and dated informed consent document
    2. Subjects are at least 18 years old
    3. Subjects with NYHA functional Class II, III or IV
    4. Subjects have an ICD or CRT-D
    5. Subjects with at least one eye meeting all eligible eye inclusion criteria and no exclusion criteria
    6. Subjects have symptomatic DCM with pre-identified deleterious LMNA mutation
    7. 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.
    8. Subjects who are affiliated to a social security system, or is a beneficiary
    Prescreening for Patients 5.2.1.2 with Unknown LMNA Mutation Status
    1. Subjects provide a signed and dated informed consent document
    2. Subjects are at least 18 years old
    3. Subjects with NYHA functional Class II, III or IV
    4. Subjects have an ICD or CRT-D
    5. 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.
    6. 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.
    7. Subjects who are affiliated to a social security system, or is a beneficiary
    Inclusion Criteria for NYHA Functional Class II and III Subjects
    1. Subjects provide a signed and dated informed consent document
    2. Subjects are at least 18 years old
    3. Subjects who symptomatic LMNA-related DCM as per the protocol
    4. Subjects have an ICD or CRT-D
    5. Subjects with objective functional impairment evidenced by a reduction in 6MWT as per the protocol
    6. Subjects with impaired function due to symptomatic DCM rather than any noncardiac comorbidity that can significantly impair function
    7. 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
    8. Subjects have acceptable hematology, hepatic and renal function laboratory values as per the protocol
    9. 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.
    10. Male subjects and female subjects of childbearing potential must agree to use a highly effective method of contraception as defined in the study protocol
    11. Subjects willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
    12. 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:

    1. Subjects with presence of other form(s) of cardiomyopathy contributing to HF or clinically significant cardiac anatomic abnormality.
    2. Subjects with clinically significant coronary artery disease
    3. Subjects with presence of a ventricular assist device or history of prior heart transplantation
    4. Subjects with uncorrected, hemodynamically significant (i.e., moderate-severe) primary structural valvular disease not due to HF
    5. Subjects currently receiving or deemed at high risk of requiring chronic renal replacement therapy (e.g., hemodialysis or peritoneal dialysis) within 6 months
    6. Subjects who have treatment with any investigational agent(s) for HF at the open-label Baseline Visit
    7. Subjects with malignancy that is active or has been diagnosed within 3 years prior to screening
    8. Subjects with Non-cardiac condition that limits lifespan to < 1 year
    9. 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
    10. Subjects with any severe concurrent disease or condition
    11. Subjects who are pregnant or breastfeeding, or patients who plan to become pregnant during the duration of the trial
    12. Subjects with documented hypersensitivity/allergy or clinically significant intolerance to any component of drug product



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