IC14 for Arrhythmogenic Cardiomyopathy
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: Implicit Bioscience
No Placebo Group
Trial Summary
What is the purpose of this trial?The goal of this clinical trial is to test IC14 (atibuclimab) in patients with arrhythmogenic cardiomyopathy (ACM) and who have an implantable cardoverter/defibrillator in place. ACM is also called arrhythmogenic right ventricular dysplasia (ARV) or arrhythmogenic right ventricular cardiomyopathy (ARVC). The main questions the study aims to answer are the effect of treatment on blood markers of inflammation, safety, and pharmacokinetics. There will also be measurements of myocardial imaging of C-C chemokine receptor type 2 (CCR2+) immune cells (optional), monitoring of cardiac arrhythmias using the patient's pre-existing intracardiac cardioverter/defibrillator (ICD) and a Holter monitor, electrocardiogram (ECG), echocardiogram (ECHO), and blood tests. Results will be compared to baseline; there is no inactive placebo treatment group.
Participants will be asked to undergo screening and baseline testing, then receive 4 intravenous infusions with blood measurements before and after the infusion (including 24, 48, and 72 hours and 7, 14, and 28 days). Participants will be offered specialized scanning of the heart muscle, and will be asked to provide recordings from their ICD, undergo Holter monitoring twice, and have electrocardiograms (ECG), echocardiograms (ECHO) and blood tests.
What safety data exists for IC14 treatment in arrhythmogenic cardiomyopathy?The provided research does not contain specific safety data for the treatment IC14 in arrhythmogenic cardiomyopathy. The studies focus on risk prediction, genetic factors, and the use of implantable cardioverter-defibrillators (ICDs) in managing arrhythmogenic cardiomyopathy, but do not mention IC14 or its safety data.157910
Is IC14 a promising treatment for Arrhythmogenic Cardiomyopathy?The information provided does not mention IC14 as a treatment for Arrhythmogenic Cardiomyopathy. The focus is on using implantable cardioverter defibrillators (ICDs) to manage the condition, which helps prevent sudden cardiac death by correcting dangerous heart rhythms.346712
What data supports the idea that IC14 for Arrhythmogenic Cardiomyopathy (also known as: IC14) is an effective treatment?The available research does not provide specific data on the effectiveness of IC14 for Arrhythmogenic Cardiomyopathy. Instead, it focuses on other treatments like implantable cardioverter-defibrillators (ICDs), which are shown to improve survival in patients with this condition. Without direct data on IC14, we can't compare its effectiveness to these alternative treatments.237811
Do I have to stop taking my current medications for the trial?The trial requires that you do not change your current ACM medications unless it's necessary for managing life-threatening conditions.
Eligibility Criteria
This trial is for patients with arrhythmogenic cardiomyopathy (ACM), a heart muscle disease that can cause irregular heartbeats. Participants must have an implantable cardioverter/defibrillator (ICD) already in place.Inclusion Criteria
I have had a serious irregular heartbeat or more than 500 early heartbeats in a day.
I am 18 years old or older.
I have a heart condition with a specific genetic marker.
I am a woman not able to have children, in menopause, or will use two birth control methods after treatment.
Exclusion Criteria
I am currently on a continuous antiarrhythmic medication infusion.
My liver and kidney functions are normal, and my liver enzymes are not three times above the normal limit.
I have not had major blood vessel surgery in the last 4 weeks.
I have not had major surgery in the last 6 weeks.
My doctor expects I have less than 1 year to live due to a non-heart related condition.
I am currently using or plan to use high-dose corticosteroids regularly.
I have had a heart attack before.
I have had an emergency procedure to correct my heart rhythm.
My heart failure is severe, limiting my ability to carry out physical activity.
I am on long-term immune system medications for arthritis.
I have no allergies to atibuclimab or similar drugs.
Participant Groups
The trial tests IC14 (atibuclimab), focusing on its effects on inflammation markers, safety, and how the body processes it. It includes blood tests, heart scans, and monitoring of heart rhythms using existing ICDs and additional devices.
1Treatment groups
Experimental Treatment
Group I: IC14 (atibuclimab)Experimental Treatment1 Intervention
IC14 (atibuclimab) 20 mg/kg intravenously every 3 weeks for 12 weeks (4 doses)
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Washington University School of MedicineSaint Louis, MO
Cleveland ClinicCleveland, OH
Loading ...
Who is running the clinical trial?
Implicit BioscienceLead Sponsor
References
Implantable cardioverter/defibrillator therapy in arrhythmogenic right ventricular cardiomyopathy: single-center experience of long-term follow-up and complications in 60 patients. [2019]Arrhythmogenic right ventricular cardiomyopathy (ARVC) is a major cause of ventricular tachycardia (VT) and cardiac arrest in young patients. We hypothesized that treatment with implantable cardioverter/defibrillators (ICDs) is safe and improves the long-term prognosis of ARVC patients at high risk of sudden death.
The impact of implantable cardioverter-defibrillator therapy on survival in autosomal-dominant arrhythmogenic right ventricular cardiomyopathy (ARVD5). [2023]We sought to determine the impact of implantable cardioverter-defibrillator (ICD) therapy in patients with familial arrhythmogenic right ventricular cardiomyopathy (ARVC).
[Clinical and ECG features of arrhythmogenic right ventricular cardiomyopathy: a retrospective analysis of 31 cases]. [2011]To retrospectively analyze the clinical and electrocardiographic features of patients with arrhythmogenic right ventricular cardiomyopathy (ARVC).
High Arrhythmic Burden but Low Mortality during Long-term Follow-up in Arrhythmogenic Right Ventricular Cardiomyopathy. [2016]Arrhythmogenic right ventricular cardiomyopathy (ARVC) is associated with a high incidence of ventricular tachyarrhythmia and sudden death. The mainstay of management is the implantable cardioverter defibrillator (ICD). A small number of patient cohorts have generated a large number of reports.
Arrhythmogenic cardiomyopathy. [2022]Arrhythmogenic cardiomyopathy (AC) is a heart muscle disease clinically characterized by life-threatening ventricular arrhythmias and pathologically by an acquired and progressive dystrophy of the ventricular myocardium with fibro-fatty replacement. Due to an estimated prevalence of 1:2000-1:5000, AC is listed among rare diseases. A familial background consistent with an autosomal-dominant trait of inheritance is present in most of AC patients; recessive variants have also been reported, either or not associated with palmoplantar keratoderma and woolly hair. AC-causing genes mostly encode major components of the cardiac desmosome and up to 50% of AC probands harbor mutations in one of them. Mutations in non-desmosomal genes have been also described in a minority of AC patients, predisposing to the same or an overlapping disease phenotype. Compound/digenic heterozygosity was identified in up to 25% of AC-causing desmosomal gene mutation carriers, in part explaining the phenotypic variability. Abnormal trafficking of intercellular proteins to the intercalated discs of cardiomyocytes and Wnt/beta catenin and Hippo signaling pathways have been implicated in disease pathogenesis.AC is a major cause of sudden death in the young and in athletes. The clinical picture may include a sub-clinical phase; an overt electrical disorder; and right ventricular or biventricular pump failure. Ventricular fibrillation can occur at any stage. Genotype-phenotype correlation studies led to identify biventricular and dominant left ventricular variants, thus supporting the use of the broader term AC.Since there is no "gold standard" to reach the diagnosis of AC, multiple categories of diagnostic information have been combined and the criteria recently updated, to improve diagnostic sensitivity while maintaining specificity. Among diagnostic tools, contrast enhanced cardiac magnetic resonance is playing a major role in detecting left dominant forms of AC, even preceding morpho-functional abnormalities. The main differential diagnoses are idiopathic right ventricular outflow tract tachycardia, myocarditis, sarcoidosis, dilated cardiomyopathy, right ventricular infarction, congenital heart diseases with right ventricular overload and athlete heart. A positive genetic test in the affected AC proband allows early identification of asymptomatic carriers by cascade genetic screening of family members. Risk stratification remains a major clinical challenge and antiarrhythmic drugs, catheter ablation and implantable cardioverter defibrillator are the currently available therapeutic tools. Sport disqualification is life-saving, since effort is a major trigger not only of electrical instability but also of disease onset and progression. We review the current knowledge of this rare cardiomyopathy, suggesting a flowchart for primary care clinicians and geneticists.
Comparison of different prediction models for the indication of implanted cardioverter defibrillator in patients with arrhythmogenic right ventricular cardiomyopathy. [2022]Arrhythmogenic right ventricular cardiomyopathy (ARVC) is associated with a high risk of sudden cardiac death. Three different prediction models for the indication of implanted cardioverter defibrillator (ICD) are now available: the 5 year ARVC risk score, the International Task Force Consensus (ITFC) criteria, and the Heart Rhythm Society (HRS) criteria. We compared these three prediction models in a validation cohort of patients with definite ARVC.
Implantable cardiac defibrillator events in patients with arrhythmogenic right ventricular cardiomyopathy. [2022]Arrhythmogenic right ventricular cardiomyopathy (ARVC) is associated with a risk of sudden cardiac death. Optimal risk stratification is still under debate. The main purpose of this long-term, single-centre observation was to analyse predictors of appropriate and inappropriate implantable cardioverter-defibrillator (ICD) interventions in the population of patients with ARVC with a high risk of life-threatening arrhythmias.
Prognostic value of late gadolinium enhancement in arrhythmogenic right ventricular cardiomyopathy: a meta-analysis. [2021]To assess systematically the prognostic value of cardiac magnetic resonance imaging (CMRI) in patients with arrhythmogenic right ventricular cardiomyopathy (ARVC).
Arrhythmic risk prediction in arrhythmogenic right ventricular cardiomyopathy: external validation of the arrhythmogenic right ventricular cardiomyopathy risk calculator. [2022]Arrhythmogenic right ventricular cardiomyopathy (ARVC) causes ventricular arrhythmias (VAs) and sudden cardiac death (SCD). In 2019, a risk prediction model that estimates the 5-year risk of incident VAs in ARVC was developed (ARVCrisk.com). This study aimed to externally validate this prediction model in a large international multicentre cohort and to compare its performance with the risk factor approach recommended for implantable cardioverter-defibrillator (ICD) use by published guidelines and expert consensus.
Inflammation on Endomyocardial Biopsy Predicts Risk of MACE in Undefined Left Ventricular Arrhythmogenic Cardiomyopathy. [2023]Predictors of major adverse cardiovascular events (MACE) in patients with undefined left ventricular arrhythmogenic cardiomyopathy (ULVACM) have not been described.
[Clinical profile and therapeutic strategies in patients with arrhythmogenic cardiomyopathy treated in a national reference institute]. [2023]To determine the epidemiological, clinical, electrocardiographic, imaging characteristics and main therapeutic strategies performed in patients with arrhythmogenic cardiomyopathy treated in a national reference cardiovascular institute.
Risk of Atrial Arrhythmias in Patients with Ventricular Tachycardia in Arrhythmogenic Right Ventricular Cardiomyopathy. [2023]In arrhythmogenic right ventricular cardiomyopathy (ARVC), risk of atrial arrhythmias (AA) persists after ventricular tachycardia (VT) ablation.