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Evaluation of the effect of statins, drugs in use to lower cholesterol, in reducing or delaying the progression of Arrhythmogenic Cardiomyopathy
EU CTIS ID: 2024-514643-28-00
What this study is testing
Efficacy of Atorvastatin in avoiding functional RV deterioration
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Diagnosis of ACM based on the 2010 Task Force criteria or Padua Criteria
- Age ≥ 18 years
- Signed the informed consent
You likely can't join if
- Known hypersensitivity to atorvastatin or any of the excipients
- Moderate or severe liver disease (persistent elevation of transaminases more than 3 times the upper limit of the normal laboratory reference range)
- 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 and/or aortic valvulopathy; pulmonary hypertension; congenital cardiac abnormalities
- Heart transplantation
See the full eligibility criteria
- Diagnosis of ACM based on the 2010 Task Force criteria or Padua Criteria
- Age ≥ 18 years
- Signed the informed consent
- Known hypersensitivity to atorvastatin or any of the excipients
- Moderate or severe liver disease (persistent elevation of transaminases more than 3 times the upper limit of the normal laboratory reference range)
- 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 and/or aortic valvulopathy; pulmonary hypertension; congenital cardiac abnormalities
- 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 (e.g. itraconazole, posaconazole, voriconazole) Protease inhibitors (e.g. ritonavir, telaprevir, boceprevir), 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 (Atorvastatin, Fluvastatin, Lovastatin, Pravastatin, Rosuvastatin, Simvastatin) Cholesterol absorption inhibitors (Ezetimibe), Bile acid sequestrants (Cholestyramine, Colestipol), PCSK9 inhibitors (Alirocumab, Evolucumab), Adenosine triphosphate-citrate lyase inhibitors (Bempedoic acid), Fibrates (Gemfibrozil, Fenofibrate, Bezafibrate), Omega-3 fatty acid ethyl esters
- Drugs with antioxidant effects (N-acetyl-cysteine)
- 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 that complies with local regulations on methods of contraception for clinical trial participants
- Known dependency on alcohol – drug abuse
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.