Evaluation of the effect of statins, drugs in use to lower cholesterol, in reducing or delaying the progression of Arrhythmogenic Cardiomyopathy

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centro Cardiologico Monzino S.p.A.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

25 Mar 2025 → ongoing

Decision date (initial)

2024-10-11

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Ministero della Salute (PNRR-MCNT2-2023-12376978)

External identifiers

EU CT number

2024-514643-28-00

WHO UTN

U1111-1309-7648

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

Efficacy of Atorvastatin in avoiding functional RV deterioration

Secondary objectives 2

1. Efficacy of Atorvastatin in avoiding electric, morphological and biomarkers deterioration
2. Safety of Atorvastatin treatment

Conditions and MedDRA coding

Arrhythmogenic Cardiomyopathy (ACM)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Diagnosis of ACM based on the 2010 Task Force criteria or Padua Criteria
2. Age ≥ 18 years
3. Signed the informed consent

Exclusion criteria 17

1. Known hypersensitivity to atorvastatin or any of the excipients
2. Fusidic acid (drug for bacterial infections)
3. Hepatitis C antivirals as telaprevir, boceprevir, glecaprevir/pibrentasvir and ledipasvir/sofosbuvir combination
4. 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
5. Drugs with antioxidant effects (N-acetyl-cysteine)
6. 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
7. Pregnant or lactating women
8. Women of childbearing age who are not using adequate contraception that complies with local regulations on methods of contraception for clinical trial participants
9. Known dependency on alcohol – drug abuse
10. Moderate or severe liver disease (persistent elevation of transaminases more than 3 times the upper limit of the normal laboratory reference range)
11. Left ventricular ejection fraction <35%
12. Congestive heart failure defined by the New York Heart Association (NYHA) as class III or IV
13. 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
14. Heart transplantation
15. Estimated life expectancy of less than 2 years
16. 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
17. Potent CYP3A4 modifiers such as Erythromycin, Clarithromycin Azole antifungals (e.g. itraconazole, posaconazole, voriconazole) Protease inhibitors (e.g. ritonavir, telaprevir, boceprevir), Gemfibrozil, Ciclosporin, Danazol

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Deterioration from baseline of RV free wall longitudinal strain measured by ECHO

Secondary endpoints 2

1. Deterioration from baseline of i) arrhythmia burden (PVC, non-sustained and sustained VA, VF, appropriate ICD shocks); ii) other morphological parameters (ventricular volumes, function, both at ECHO and CMR); iii) ECG parameters; iv) blood parameters
2. Monitoring of AE

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centro Cardiologico Monzino S.p.A.

Sponsor organisation

Centro Cardiologico Monzino S.p.A.

Address

Via Carlo Parea 4

City

Milan

Postcode

20138

Country

Italy

Scientific contact point

Organisation

Centro Cardiologico Monzino S.p.A.

Contact name

Sommariva Elena

Public contact point

Organisation

Centro Cardiologico Monzino S.p.A.

Contact name

Sommariva Elena

Third parties 3

Locations

1 EU/EEA country · 5 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications