Statin Effect on Arrhythmogenic Cardiomyopathy Disease Progression

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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: 1. Does Atorvastatin 80 mg prevent worstening of the right ventricular functioning? 2. Does Atorvastatin 80 mg prevent the worsening of electric, morphological and biomarkers deterioration? 3. 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: 1. Take Atorvastatin 80 mg or a placebo every day for 18 months; 2. Visit the clinic at the enrollment and after 2, 4, 9 and 18 months for checkups and tests; 3. Make a phone call for safety check after 12, 15 and 19 months since the enrollment; 4. Fill out psychological questionnaires

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
Università Politecnica delle Marche
RECRUITING
Ancona
Centro Cardiologico Monzino IRCSS
RECRUITING
Milan
AORN - Ospedali dei Colli
RECRUITING
Napoli
Università degli Studi di Napoli Federico II
NOT_YET_RECRUITING
Napoli
Fondazione I.R.C.C.S. Policlinico San Matteo
RECRUITING
Pavia
Contact Information
Primary
Elena Sommariva
elena.sommariva@cardiologicomonzino.it
+39 0258002752
Backup
Claudio Tondo
claudio.tondo@cardiologicomonzino.it
+39 0258002275
Time Frame
Start Date: 2025-03-31
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 102
Treatments
Active_comparator: Atorvastatin
Atorvastatin arm will be composed by 51 patients affected by Arrhythmogenic Cardiomyopathy.
Placebo_comparator: Placebo
Placebo arm will be composed by 51 patients affected by Arrhythmogenic Cardiomyopathy.
Related Therapeutic Areas
Sponsors
Leads: Centro Cardiologico Monzino
Collaborators: Ospedali dei Colli, Federico II University, Università Politecnica delle Marche

This content was sourced from clinicaltrials.gov

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