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A Study With NVC-001 in Patients With LMNA-related Dilated Cardiomyopathy (SUNBEAM-LMNA)

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllNuevocor Pte. Ltd.
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In plain words

What the trial is, and whether it could suit you

This study is designed to evaluate the safety and tolerability of NVC-001 in adults with LMNA-related dilated cardiomyopathy (LMNA-DCM). The study will also assess exploratory measures of efficacy.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Key Inclusion Criteria: 1. Adult โ‰ฅ18 years old, able to provide informed consent 2. Clinical diagnosis of LMNA-related dilated cardiomyopathy (DCM) with LV systolic dysfunction 3. Pathogenic or likely pathogenic LMNA mutation confirmed by a CLIA-certified/CAP-accredited laboratory 4. NYHA Functional Class I, II, or III 5. LVEF \>25% and โ‰ค45% by echocardiography 6. Implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillator )CRT-D) implanted \>3 months prior to consent Key Exclusion Criteria: 1. Any chronic medical condition that, in the Investigator's opinion, would compromise participant safety or compliance 2. Hospitalization as an inpatient for the following conditions within 3 months prior to signing the ICF: Heart failure, Persistent/refractory ventricular arrhythmia requiring external defibrillation, or multiple/recurrent cardioversion/defibrillation by ICD Indication for, or history of, LV assist device or cardiac transplantation due to end-stage cardiac dysfunction 3. Current or anticipated need for chronic IV inotropic therapy
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What it tests

  • NVC-001 - Low Dose
  • NVC-001 - Intermediate Dose
  • NVC-001 - High Dose
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Where

8 sites
University of Alabama in Birmingham
Birmingham, United States
Cedars-Sinai Medical Center
Los Angeles, United States
Brigham and Women's Hospital
Boston, United States
University of Michigan
Ann Arbor, United States
Mayo Clinic
Rochester, United States
The Christ Hospital
Cincinnati, United States
The Ohio State University
Columbus, United States
Houston Methodist Hospital
Houston, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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