Phase 4 Heart Disease Trial, Recruiting NCT06793670 Sponsor: Università Vita-Salute San Raffaele Condition: Heart Disease
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Phase 4 Heart Disease Trial, Recruiting

NCT06793670
Recruiting Phase 4

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 who are over 18 years old
  • People who are scheduled for planned (non-emergency) mitral heart valve repair or replacement surgery using a heart-lung bypass machine, through either a chest incision down the middle or a smaller side incision
  • People whose heart scans before surgery show that their left heart chamber is enlarged or not pumping as strongly as normal (confirm with trial site for specific measurements)
  • People who have signed a form agreeing to take part in the trial

Who may not be able to join:

  • People who need kidney dialysis before surgery
  • People with severe liver disease (known as Child-Pugh class C)
  • People who have had an unusual or unexpected reaction to beta-blocker medicines in the past
  • People who need urgent or emergency surgery
  • People who already need a mechanical device to help their heart pump before surgery (with the exception of one specific type of device called an IABP)
  • People who are pregnant, confirmed by a pregnancy test taken within 72 hours before surgery
  • People whose pre-surgery blood tests show sodium levels that are too high (above 160 mmol/L)
  • People whose pre-surgery blood tests show chloride levels that are too high (above 115 mmol/L)
  • People who are known to be allergic to the study drug or any of its ingredients
  • People with a very slow heart rate (under 50 beats per minute), certain heart rhythm or electrical conduction problems, and who do not have a pacemaker
  • People with a heart in a state of shock, very low blood pressure, severe worsening heart failure, or severely high pressure in the lungs
  • People with an untreated tumour of the adrenal gland (called phaeochromocytoma)
  • People currently experiencing an acute asthma attack
  • People with severe and uncorrectable acid build-up in the blood (metabolic acidosis)
  • People who have taken part in another clinical trial involving an experimental drug within the past 30 days (or longer, depending on the drug involved)
  • People for whom a specific type of very short-acting beta-blocker medicine is already planned as part of their surgery
  • People who are unwilling or unable to sign the informed consent form

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 19 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Phone: 0226436154

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

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 4
Sponsor
Università Vita-Salute San Raffaele
Registry
ClinicalTrials.gov
Start date
28 January 2025
Est. completion
1 June 2027

Where this trial is recruiting

🇮🇹 Italy

Primary endpoints

Reduction of the occurrence of postoperative low-cardiac output syndrome (LCOS)

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: 19 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