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New treatment option for Arrhythmogenic Cardiomyopathy
Official title Statin Effect on Arrhythmogenic Cardiomyopathy Disease Progression (SEARCH)
ClinicalTrials.gov ID: NCT06922994
What this study is testing
What is Atorvastatin 80 mg/day?
Atorvastatin 80 mg/day is an investigational medicine, being studied as a potential treatment for arrhythmogenic cardiomyopathy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
See the full eligibility criteria
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Pavia, PV, Italy
- Ancona, Italy
- Milan, Italy
- Naples, Italy
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pavia, PV, Italy; Ancona, Italy; Milan, Italy; Naples, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.