Health TrialsbyHealthPanel

Statin Effect on Arrhythmogenic Cardiomyopathy Disease Progression (SEARCH)

ConditionArrhythmogenic Cardiomyopathy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentro Cardiologico Monzino

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Known hypersensitivity to atorvastatin or any of the excipients

Moderate or severe liver disease

Muscle disease

Left ventricular ejection fraction <35%

Trial design

Design model

Parallel

Treatments tested in this trial

  • Atorvastatin 80 mg/day

    Drug

    Atorvastatin 80mg/day will be administered for 18 months to patients affected by Arrhythmogenic Cardiomyopathy

  • Placebo atorvastatin

    Drug

    One tablet of placebo will be administered for 18 months to patients affected by Arrhythmogenic Cardiomyopathy

Treatment groups

102 Participants
are divided into 2 treatment groups
Group A: AtorvastatinActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Efficacy of Atorvastatin in avoiding functional right ventricular deterioration

Variation of right ventricular free wall longitudinal strain measured by echocardiography after 18 months respect to baseline (%)

Time frame
From enrollment to the end of treatment at 18 months

Secondary outcomes

1

Safety of Atorvastatin treatment

Monitoring of adverse events and patient's well-being.

Time frame
From enrollment to 1 month after the end of treatment (19 months)
2

Efficacy of Atorvastatin in avoiding morphological deterioration (ventricular volumes)

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)
3

Efficacy of Atorvastatin in avoiding morphological deterioration (wall thickness )

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)
4

Efficacy of Atorvastatin in avoiding morphological deterioration (cardiac function )

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 (18 months)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centro Cardiologico Monzino

Lead sponsor

Federico II University

Collaborator

Università Politecnica delle Marche

Collaborator

Ospedali dei Colli

Collaborator

Source ClinicalTrials.gov
Apply now