Cardiomyopathy Trial, Recruiting NCT05793008 Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Condition: Cardiomyopathy
Back to Cardiomyopathy

Cardiomyopathy Trial, Recruiting

NCT05793008
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

For people with Takotsubo Syndrome (TTS) — a temporary heart condition often triggered by stress:

  • Written consent has been provided by the patient, or by a parent, guardian, or legal representative on their behalf.
  • A diagnosis of TTS has been confirmed by a doctor using recognised medical diagnostic criteria, including unusual heart muscle movement, no significant blockages in the heart arteries, new changes on a heart tracing (ECG) or elevated heart injury markers in the blood, and no evidence of a hormone-producing tumour or heart inflammation.

For people with sepsis — a life-threatening response to infection:

  • Written consent has been provided by the patient, or by a parent, guardian, or legal representative on their behalf.
  • A diagnosis of sepsis has been confirmed, meaning a serious infection has caused the body to respond in a way that is damaging organs, shown by a significant worsening in an organ failure score used by doctors.
  • A diagnosis of septic shock has been confirmed, meaning the patient requires medication to keep blood pressure at a safe level, and blood tests show a build-up of a substance called lactate, indicating the body is not getting enough oxygen.
  • The sepsis has caused the heart to function poorly (either in how it pumps or how it relaxes), in a person who had no known heart disease before becoming unwell.

Who may not be able to join:

  • There is another explanation for the patient's symptoms that better accounts for their condition.
  • For TTS patients: there are reasons why a PET scan (a type of imaging test) cannot safely be performed — including pregnancy, breastfeeding, or plans to become pregnant during the study period.
  • The patient has other serious health conditions that mean they are not expected to survive beyond one year.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Rocco A Montone, MD, PhD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Phone: +39-0630154187

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
30 March 2023
Est. completion
2 March 2026

Where this trial is recruiting

🇮🇹 Italy

Primary endpoints

Association between brain activation and clinical profile and outcome in Takotsubo Syndrome

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov