Oxidized LDL-dependent pathway as new pathogenic trigger in arrhythmogenic cardiomyopathy.
Elena Sommariva, Ilaria Stadiotti, Michela Casella...
https://pubmed.ncbi.nlm.nih.gov/34337880Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID06922994
Statin Effect on Arrhythmogenic Cardiomyopathy Disease Progression
Led by Centro Cardiologico Monzino · Updated on 2025-07-03
102
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Centro Cardiologico Monzino
Lead Sponsor
F
Federico II University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether Atorvastatin 80 mg can prevent worsening of right ventricular function and other heart-related changes in patients with Arrhythmogenic Cardiomyopathy. The study also aims to assess the safety of Atorvastatin 80 mg in this patient group by comparing it with a placebo. Important questions include if the drug prevents electrical, structural, and biomarker deterioration and what medical issues may occur during treatment. Participants will be randomly assigned to take either Atorvastatin 80 mg or a placebo daily for 18 months. The study includes 51 patients in each group affected by Arrhythmogenic Cardiomyopathy. During the study, participants will visit the clinic at enrollment and after 2, 4, 9, and 18 months for various tests and checkups. Safety follow-up phone calls will be conducted at 12, 15, and 19 months, and participants will complete psychological questionnaires. Throughout the study, researchers will monitor heart function, electrical activity, structural changes, arrhythmias, and biomarkers related to heart health from enrollment through 18 months of treatment. Safety will be assessed up to one month after treatment ends (19 months). This includes detailed heart imaging and blood tests to track disease progression and any effects of the drug. The total participation lasts about 19 months with ongoing safety monitoring and assessments.
CONDITIONS
Brief Title
Statin Effect on Arrhythmogenic Cardiomyopathy Disease Progression (SEARCH)
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- Known hypersensitivity to atorvastatin or any of the excipients
- Moderate or severe liver disease
- Muscle disease
- Left ventricular ejection fraction less than 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 places the patient at risk, makes the patient unreliable, or limits ability to complete the study
- Use of potent CYP3A4 modifiers such as Erythromycin, Clarithromycin, Azole antifungals, Protease inhibitors, Gemfibrozil, Ciclosporin, Danazol
- Use of Fusidic acid
- Use of Hepatitis C antivirals like telaprevir, boceprevir, glecaprevir/pibrentasvir, ledipasvir/sofosbuvir
- Use of other lipid lowering drugs such as Statins, Cholesterol absorption inhibitors, Bile acid sequestrants, PCSK9 inhibitors, ATP-citrate lyase inhibitors, Fibrates, Omega-3 fatty acid ethyl esters
- Use of drugs primarily indicated as antioxidants
- Enrollment in another clinical trial involving investigational drugs within 30 days or 5 half-lives
- Pregnant or lactating women
- Women of childbearing age not using adequate contraception
- Known dependency on alcohol or drug abuse
- Contraindications to cardiac magnetic resonance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 18 months
Participants receive either Atorvastatin 80 mg/day or placebo for Arrhythmogenic Cardiomyopathy to assess the effect on disease progression.
Visits scheduled throughout the 18 months of treatment
Follow-up
Duration - 1 month
Participants are monitored for safety and any adverse effects for 1 month after completing treatment.
1 follow-up visit (in-person)
Trial Site Locations
Total: 5 locations
1
Fondazione I.R.C.C.S. Policlinico San Matteo
Pavia, PV, Italy, 27100
Actively Recruiting
2
Università Politecnica delle Marche
Ancona, Italy, 60126
Actively Recruiting
3
Centro Cardiologico Monzino IRCSS
Milan, Italy, 20138
Actively Recruiting
4
AORN - Ospedali dei Colli
Naples, Italy, 80131
Actively Recruiting
5
Università degli Studi di Napoli Federico II
Naples, Italy, 80138
Not Yet Recruiting
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Research Team
E
Elena Sommariva
C
Claudio Tondo
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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