UnknownNot Applicable

Subanalysis in Patients With CARDIoLAMinopathy Enrolled to REPORT-CCM Registry

Italy20 participantsStarted 2021-03-08

Plain-language summary

Observational, retrospective registry with acute and chronic endpoints

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or non-pregnant female, aged 18 or older; * chronic heart failure with symptomatic left ventricular systolic function (NYHA class II-IVa) with or without device already implanted (for example AICD, pace-maker); * Appropriate and optimized medical therapy; * Patient signed and dated informed consent form at enrollment; * life expectancy\> 1 year due to the absence of comorbidities that reduce the prognosis Exclusion Criteria: * absence of venous access available for implant; * contraindication to the interventional procedure of CCM device implant (for example presence of Mechanical tricuspid vale); * pregnant patients

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Improvement of QoL

Timeframe: 12 months

Reduction of HF Hospitalizations and Emergency Ward accesses

Timeframe: 12 months

Improvement of Fuctional Capacity

Timeframe: 12 months

Trial details

NCT IDNCT04904393

SponsorMonaldi Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-12-31

Contact for this trial

Antonio D'Onofrio, MD

+39 0817062605 donofrioant1@gmail.com

View on ClinicalTrials.gov More Laminopathy trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.