Heart Disease Trial, Recruiting NCT06475456 Sponsor: Fondazione GISE Onlus Condition: Heart Disease
Back to Heart Disease

Heart Disease Trial, Recruiting

NCT06475456
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:

  • People aged 18 to 75 years old
  • People who are conscious and able to sign and date a consent form agreeing to take part and to their personal data being used
  • People who are unconscious, where a legal representative, proxy, or relative has signed and dated a consent form on their behalf (and the patient themselves will be asked to consent once their health improves)
  • People who have dangerously low blood pressure (either the top number below 90 mmHg, or the average pressure below 60 mmHg) even after being given fluids, OR who need medication or a mechanical device to keep their blood pressure at a safe level
  • People who also show at least one sign that their body is not getting enough blood or oxygen — such as low oxygen levels in the blood returning to the heart, high lactate levels in the blood (a sign of poor circulation), or very low urine output for at least 6 hours
  • People whose cardiogenic shock (a condition where the heart suddenly cannot pump enough blood) was caused either by a heart attack or by a sudden worsening of existing heart failure

Who may not be able to join:

  • People who had a cardiac arrest where there was a period of no resuscitation attempts that cannot be measured or lasted longer than 10 minutes, or where CPR continued for more than 20 minutes without success
  • People who have an absolute medical reason why they cannot use mechanical heart support devices
  • People whose cardiogenic shock was caused by something other than a heart attack or acute heart failure worsening, or who are in the least severe or most severe category of shock (SCAI A or E) before any device is placed (confirm with trial site)
  • People older than 75 years
  • People whose life expectancy is less than 1 year for reasons unrelated to their cardiogenic shock

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 14 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: Alaide Chieffo, Prof, IRCCS San Raffaele Hospital

Phone: +390226437331

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
Sponsor
Fondazione GISE Onlus
Registry
ClinicalTrials.gov
Start date
1 December 2024
Est. completion
3 November 2026

Where this trial is recruiting

🇮🇹 Italy

Primary endpoints

Mortality.

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: 14 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