NCT06922994招募中2 期
Statin Effect on Arrhythmogenic Cardiomyopathy Disease Progression
Centro Cardiologico Monzino5 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2025年3月31日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 102
- 试验地点
- 5
- 主要终点
- Efficacy of Atorvastatin in avoiding functional right ventricular deterioration
研究概览
简要总结
The goal of this clinical trial is to learn if Atorvastatin 80 mg is effective to avoid functional right ventricular deterioration in patients affected by Arrhythmogenic Cardiomyopathy. It will also learn about the safety of Atorvastatin 80 mg in this type of patients. The main questions it aims to answer are:
- Does Atorvastatin 80 mg prevent worstening of the right ventricular functioning?
- Does Atorvastatin 80 mg prevent the worsening of electric, morphological and biomarkers deterioration?
- What medical problems do participants have when taking Atorvastatin 80 mg?
Researchers will compare Atorvastatin 80 mg to a placebo (a look-alike substance that contains no drug) to see if the drug works to treat Arrhythmogenic Cardiomyopathy.
Participants will:
- Take Atorvastatin 80 mg or a placebo every day for 18 months;
- Visit the clinic at the enrollment and after 2, 4, 9 and 18 months for checkups and tests;
- Make a phone call for safety check after 12, 15 and 19 months since the enrollment;
- Fill out psychological questionnaires
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must be at least 18 years of age, at the time of signing the informed consent
- •Participants affected by Arrhythmogenic Cardiomyopathy as defined by task force criteria
排除标准
- •Known hypersensitivity to atorvastatin or any of the excipients
- •Moderate or severe liver disease
- •Muscle disease
- •Left ventricular ejection fraction <35%
- •Congestive heart failure defined by the New York Heart Association (NYHA) as class III or IV.
- •Known cardiomyopathy of other origin: post ischemic, hypertrophic, idiopathic dilated, restrictive; known moderate-to-severe mitral or aortic valvulopathy; pulmonary hypertension; congenital cardiac abnormalities
- •Hypercholesterolemic patients that require the use of lipid lowering drugs.
- •Heart transplantation
- •Estimated life expectancy of less than 2 years
- •Any other medical condition that, in the judgment of the investigator, places the patient at risk or makes the patient unreliable or limits the patient's ability to complete the study
- •Potent CYP3A4 modifiers such as Erythromycin, Clarithromycin Azole antifungals, Protease inhibitors , Gemfibrozil, Ciclosporin, Danazol
- •Fusidic acid (drug for bacterial infections)
- •Hepatitis C antivirals as telaprevir, boceprevir, glecaprevir/pibrentasvir and ledipasvir/sofosbuvir combination
- •Any other lipid lowering drugs such as Statins, Cholesterol absorption inhibitors, Bile acid sequestrants , PCSK9 inhibitors, Adenosine triphosphate-citrate lyase inhibitors , Fibrates, Omega-3 fatty acid ethyl esters
- •Drugs primary indicated as antioxidants
- •Enrollment in another clinical trial or past clinical trial in which an investigational drug was administered within 30 days of Visit 1 or within the 5 half-lives of the investigational drug, whichever is longer.
- •Pregnant or lactating women
- •Women of childbearing age who are not using adequate contraception
- •Known dependency on alcohol - drug abuse.
- •Contraindications to cardiac magnetic resonance
研究组 & 干预措施
Atorvastatin
Active Comparator
Atorvastatin arm will be composed by 51 patients affected by Arrhythmogenic Cardiomyopathy.
干预措施: Atorvastatin 80 mg/day (Drug)
Placebo
Placebo Comparator
Placebo arm will be composed by 51 patients affected by Arrhythmogenic Cardiomyopathy.
干预措施: Placebo atorvastatin (Drug)
结局指标
主要结局
Efficacy of Atorvastatin in avoiding functional right ventricular deterioration
时间窗: From enrollment to the end of treatment at 18 months
Variation of right ventricular free wall longitudinal strain measured by echocardiography after 18 months respect to baseline (%)
次要结局
- Safety of Atorvastatin treatment(From enrollment to 1 month after the end of treatment (19 months))
- Efficacy of Atorvastatin in avoiding morphological deterioration (ventricular volumes)(From enrollment to the end of treatment (18 months))
- Efficacy of Atorvastatin in avoiding morphological deterioration (wall thickness )(From enrollment to the end of treatment (18 months))
- Efficacy of Atorvastatin in avoiding morphological deterioration (cardiac function )(From enrollment to the end of treatment (18 months))
- Efficacy of Atorvastatin in avoiding arrhythmic deterioration (premature ventricular contractions)(From enrollment to the end of treatment at 18 months)
- Efficacy of Atorvastatin in avoiding arrhythmic deterioration (nonsustained ventricular arrhythmias)(From enrollment to the end of treatment at 18 months)
- Efficacy of Atorvastatin in avoiding arrhythmic deterioration (sustained ventricular arrhythmias)(From enrollment to the end of treatment at 18 months)
- Efficacy of Atorvastatin in avoiding arrhythmic deterioration (ventricular fibrillation )(From enrollment to the end of treatment at 18 months)
- Efficacy of Atorvastatin in avoiding arrhythmic deterioration (ICD shocks)(From enrollment to the end of treatment at 18 months)
- Efficacy of Atorvastatin in avoiding electrocardiographic deterioration (QRS)(From enrollment to the end of treatment (18 months))
- Efficacy of Atorvastatin in avoiding electrocardiographic deterioration (QT)(From enrollment to the end of treatment (18 months))
- Efficacy of Atorvastatin in avoiding electrocardiographic deterioration (PR)(From enrollment to the end of treatment (18 months))
- Efficacy of Atorvastatin in avoiding electrocardiographic deterioration (amplitudes)(From enrollment to the end of treatment (18 months))
- Efficacy of Atorvastatin in avoiding electrocardiographic deterioration (T wave)(From enrollment to the end of treatment (18 months))
- Efficacy of Atorvastatin in avoiding electrocardiographic deterioration (ԑ wave)(From enrollment to the end of treatment (18 months))
- Efficacy of Atorvastatin in avoiding biomarkers deterioration (oxLDL)(From enrollment to the end of treatment (18 months))
- Efficacy of Atorvastatin in avoiding biomarkers deterioration (MDA)(From enrollment to the end of treatment (18 months))
- Efficacy of Atorvastatin in avoiding biomarkers deterioration (4HNE)(From enrollment to the end of treatment (18 months))
- Efficacy of Atorvastatin in avoiding biomarkers deterioration (estradiol)(From enrollment to the end of treatment (18 months))
- Efficacy of Atorvastatin in avoiding biomarkers deterioration (testosterone)(From enrollment to the end of treatment (18 months))
- Efficacy of Atorvastatin in avoiding biomarkers deterioration (BIN1)(From enrollment to the end of treatment (18 months))
- Efficacy of Atorvastatin in avoiding biomarkers deterioration (GAL3)(From enrollment to the end of treatment (18 months))
- Efficacy of Atorvastatin in avoiding biomarkers deterioration (HSP70)(From enrollment to the end of treatment (18 months))
- Efficacy of Atorvastatin in avoiding biomarkers deterioration (TGFb)(From enrollment to the end of treatment (18 months))
- Efficacy of Atorvastatin in avoiding biomarkers deterioration (ST2)(From enrollment to the end of treatment (18 months))
- Efficacy of Atorvastatin in avoiding biomarkers deterioration (BNP)(From enrollment to the end of treatment (18 months))
- Efficacy of Atorvastatin in avoiding biomarkers deterioration (NTproBNP)(From enrollment to the end of treatment (18 months))
- Efficacy of Atorvastatin in avoiding biomarkers deterioration (hs-cTnI)(From enrollment to the end of treatment (18 months))
- Efficacy of Atorvastatin in avoiding biomarkers deterioration (CRP)(From enrollment to the end of treatment (18 months))
- Efficacy of Atorvastatin in avoiding biomarkers deterioration (IL6)(From enrollment to the end of treatment (18 months))
- Efficacy of Atorvastatin in avoiding biomarkers deterioration (TNF alfa)(From enrollment to the end of treatment (18 months))
研究者
研究点 (5)
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