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Search / Trial NCT06321900

Personalized Risk Prediction of Sudden Cardiac Death

Launched by ISTITUTO AUXOLOGICO ITALIANO · Mar 14, 2024

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

Personalized Medicine Sudden Cardiac Death Artificial Intelligence Genetics Cardiovascular Imaging Radiomics

ClinConnect Summary

The RESPECT trial is studying how to better predict the risk of sudden cardiac death (SCD) in patients with heart conditions. This is important because many people with heart disease may not be accurately identified as being at high risk, especially those with a heart function measurement (known as left ventricular ejection fraction or LVEF) greater than 35%. By using a combination of different types of information—like genetics, heart imaging, and blood tests—the researchers hope to create a more personalized way to assess each patient’s risk. This approach could lead to better decisions about who should receive an implantable cardioverter-defibrillator (ICD), a device that helps prevent sudden cardiac death.

To be eligible for this trial, participants need to have a history of certain heart conditions, specifically ischemic cardiomyopathy (a condition caused by reduced blood flow to the heart) with an LVEF of less than 50%, and be in NYHA class II or III (which indicates the severity of heart failure). Those interested in participating can expect to undergo various tests and evaluations, and they must provide informed consent to join. It’s important to note that some individuals, such as those with severe heart failure symptoms or recent heart issues, will not be eligible for the study. By participating, individuals might help improve how doctors predict and manage the risk of sudden cardiac death in future patients.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • history of ischemic cardiomyopathy, LVEF \<50% by 2D echo, and NYHA class II or III;
  • primitive (dilated, hypertrophic, and arrhythmogenic) cardiomyopathies at risk of SCD;
  • signed informed consent to be part of the study.
  • Exclusion Criteria:
  • unwilling to be part of the study,
  • NYHA class IV,
  • history of unexplained syncope, aborted SCD or documented sustained ventricular tachycardia,
  • insufficient acoustic window to allow the quantitation of LVEF by 2D echocardiography without the infusion of contrast agents (i.e., more than 2 LV segments not adequately visualized),
  • atrial fibrillation during the echocardiographic or CMR studies,
  • myocardial infarction in the 40 days or revascularization in the 90 days preceding the enrolment,
  • more than moderate stenosis or regurgitation of any heart valve.

About Istituto Auxologico Italiano

Istituto Auxologico Italiano is a prominent Italian research institute dedicated to advancing medical science and improving patient care through innovative clinical research. With a strong focus on metabolic diseases, cardiovascular health, and neuropsychological disorders, the institute integrates clinical practice with cutting-edge research to foster the development of new therapeutic strategies. Committed to ethical standards and patient safety, Istituto Auxologico Italiano collaborates with various national and international partners, contributing significantly to the global medical community while ensuring high-quality care and support for its patients.

Locations

Milan, , Italy

Patients applied

0 patients applied

Trial Officials

Luigi Badano, MD, Ph.D.

Principal Investigator

Istituto Auxologico Italiano, IRCCS

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported