Atorvastatin 80 mg/day
DrugAtorvastatin 80mg/day will be administered for 18 months to patients affected by Arrhythmogenic Cardiomyopathy
NCT Number: NCT06922994
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
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Fondazione I.R.C.C.S. Policlinico San Matteo, Pavia, PV, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Atorvastatin 80mg/day will be administered for 18 months to patients affected by Arrhythmogenic Cardiomyopathy
One tablet of placebo will be administered for 18 months to patients affected by Arrhythmogenic Cardiomyopathy
Time frame: 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 (%)
Time frame: From enrollment to 1 month after the end of treatment (19 months)
Monitoring of adverse events and patient's well-being.
Time frame: From enrollment to the end of treatment (18 months)
Deterioration from baseline of other morphological parameters measured both at echocardiography and cardiac magnetic resonance: ventricular volumes (ml)
Time frame: From enrollment to the end of treatment (18 months)
Deterioration from baseline of other morphological parameters measured both at echocardiography and cardiac magnetic resonance: wall thickness (mm)
Time frame: From enrollment to the end of treatment (18 months)
Deterioration from baseline of other morphological parameters measured both at echocardiography and cardiac magnetic resonance: cardiac function (%)
Time frame: From enrollment to the end of treatment at 18 months
Deterioration from baseline of arrhythmia burden: premature ventricular contractions (number in the 24h)
Time frame: From enrollment to the end of treatment at 18 months
Deterioration from baseline of arrhythmia burden: nonsustained ventricular arrhythmias (number)
Time frame: From enrollment to the end of treatment at 18 months
Deterioration from baseline of arrhythmia burden: sustained ventricular arrhythmias (number)
Time frame: From enrollment to the end of treatment at 18 months
Deterioration from baseline of arrhythmia burden: ventricular fibrillation (number)
Time frame: From enrollment to the end of treatment at 18 months
Deterioration from baseline of arrhythmia burden: appropriate ICD shocks (number)
Time frame: From enrollment to the end of treatment (18 months)
Deterioration from baseline of electrocardiographic parameters: QRS duration (ms)
Time frame: From enrollment to the end of treatment (18 months)
Deterioration from baseline of electrocardiographic parameters: QT duration (ms)
Time frame: From enrollment to the end of treatment (18 months)
Deterioration from baseline of electrocardiographic parameters: PR duration (ms)
Time frame: From enrollment to the end of treatment (18 months)
Deterioration from baseline of electrocardiographic parameters: amplitude of the potential (mV)
Time frame: From enrollment to the end of treatment (18 months)
Deterioration from baseline of electrocardiographic parameters: ), T wave inversion (number of presences in V1-V6)
Time frame: From enrollment to the end of treatment (18 months)
Deterioration from baseline of electrocardiographic parameters: ԑ wave in V1-V3 (presence)
Time frame: From enrollment to the end of treatment (18 months)
Deterioration from baseline of blood parameters: oxLDL (mU/ml)
Time frame: From enrollment to the end of treatment (18 months)
Deterioration from baseline of blood parameters: MDA (ng/ml)
Time frame: From enrollment to the end of treatment (18 months)
Deterioration from baseline of blood parameters: 4HNE (pg/ml)
Time frame: From enrollment to the end of treatment (18 months)
Deterioration from baseline of blood parameters: estradiol (pg/ml)
Time frame: From enrollment to the end of treatment (18 months)
Deterioration from baseline of blood parameters: testosterone (ng/ml)
Time frame: From enrollment to the end of treatment (18 months)
Deterioration from baseline of blood parameters: BIN1 (pg/ml)
Time frame: From enrollment to the end of treatment (18 months)
Deterioration from baseline of blood parameters: GAL3 (ng/ml)
Time frame: From enrollment to the end of treatment (18 months)
Deterioration from baseline of blood parameters: HSP70 (ng/mL)
Time frame: From enrollment to the end of treatment (18 months)
Deterioration from baseline of blood parameters: TGFb (pg/mL)
Time frame: From enrollment to the end of treatment (18 months)
Deterioration from baseline of blood parameters: ST2 (ng/ml)
Time frame: From enrollment to the end of treatment (18 months)
Deterioration from baseline of blood parameters: BNP (pg/mL)
Time frame: From enrollment to the end of treatment (18 months)
Deterioration from baseline of blood parameters: NTproBNP (pg/mL)
Time frame: From enrollment to the end of treatment (18 months)
Deterioration from baseline of blood parameters: hs-cTnI (ng/L)
Time frame: From enrollment to the end of treatment (18 months)
Deterioration from baseline of blood parameters: CRP (mg/L)
Time frame: From enrollment to the end of treatment (18 months)
Deterioration from baseline of blood parameters: IL6 (pg/ml)
Time frame: From enrollment to the end of treatment (18 months)
Deterioration from baseline of blood parameters: TNF alfa (pg/ml)
Contact information is provided by the study sponsor or research team.
Claudio Tondo
CONTACT
Elena Sommariva
CONTACT
Centro Cardiologico Monzino
Other
Statin Effect on Arrhythmogenic Cardiomyopathy Disease Progression
Acronym: SEARCH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06174220
Arrhythmias, Cardiac, Arrhythmogenic Cardiomyopathy
Calgary, Alberta, Canada
View Trial DetailsNCT06275893
ACM, ARVC
St Louis, Missouri, United States
View Trial DetailsNCT07354646
Aortic Stenosis, Subvalvular, Aortic Valve Disease
Beijing, Beijing Municipality, China
View Trial DetailsNCT06976606
Arrhythmogenic Cardiomyopathy, Arrhythmogenic Right Ventricular Dysplasia
Redwood City, California, United States
View Trial Details