Phase 2 Heart Disease Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have signed an informed consent form agreeing to take part in the study.
• People diagnosed with cardiogenic shock (a serious condition where the heart cannot pump enough blood), confirmed by needing medications to keep blood pressure up, having elevated levels of a substance in the blood called lactate (≥ 2.0 mmol/L), and having a high level of a specific protein called cDPP3 (≥ 30 ng/mL) in the blood.
• People whose cardiogenic shock was caused by one of three specific conditions: a heart attack (acute coronary syndrome), a severe infection affecting the heart (septic origin), or advanced heart failure (confirm with trial site for exact definitions).

Who may not be able to join:

• People who have been receiving blood pressure-supporting medications for more than 16 hours before the study treatment would be given.
• People who have been in an intensive care unit (ICU) for longer than 24 hours at the time they would be enrolled in the study.
• People under 18 or over 80 years of age.
• People currently receiving specific medications called Angiotensin II or levosimendan.
• People with known allergies or sensitivities to the study drug or its ingredients, or to related medications.
• People who have had a stroke or a mini-stroke (transient ischemic attack) within the past 3 months.
• People whose cardiogenic shock has been classified as the most severe stage (SCAI Stage E — the most critical category of shock).
• People who, before becoming ill with shock, were expected to live less than 6 months due to other serious health conditions.
• People who are in very severe physical decline, extremely frail, or showing signs that death is very close.
• For Part 1 of the study only: people who are using certain mechanical heart or kidney support devices (such as ECMO, Impella, or a ventricular assist device — except for an intra-aortic balloon pump), or who are on dialysis-type kidney treatment — unless they are using an Impella or ECMO device and there is no sign of a blood cell breakdown problem called hemolysis during the screening period (confirm with trial site).
• People weighing more than 120 kg (or more than 150 kg for sites in the United States).
• People who required CPR (resuscitation) for more than 15 minutes, or who are not fully conscious at the time of enrolment.
• People with certain specific heart conditions present before the shock, including a heart muscle disease that is thickened or stiff (hypertrophic or restrictive cardiomyopathy), a heart condition present from birth (congenital heart disease), or a systemic illness known to cause deposits to build up in the heart.
• People with a condition called pericardial constriction, where the sac around the heart has become stiff.
• People whose top blood pressure reading was above 120 mmHg during the hour before enrolment.
• People with any of the following serious pre-existing health conditions: severe chronic liver disease (MELD score above 30), severe chronic lung disease (including the most serious stage of COPD, dependence on oxygen therapy, or severe lung scarring), severe thyroid disease, severe chronic kidney disease (eGFR below 20 ml/min/1.73 m²), or long-term dialysis.
• People with an active, untreated serious infection (sepsis) that has not been addressed.
• People whose cardiogenic shock is primarily caused by a problem with one of the heart's valves.
• People whose shock is caused by something other than the three eligible causes, including: severe dehydration or low blood volume, significant bleeding, a severe allergic reaction, poisoning or drug-induced shock, a specific type of blockage in the heart's outflow tract, isolated right-side heart failure (including fluid around the heart or a blood clot in the lungs), or a known physical complication from a heart attack such as a torn muscle or ruptured wall in the heart, or a malfunction of an implanted heart device (ICD).
• People with severely weakened immune systems, including those who have had chemotherapy within the last 3 months, have very low white blood cell counts (severe neutropenia), are taking high doses of steroid medications long-term, or have had an organ transplant within the last 3 months.
• People who have had surgery within the last 7 days — with exceptions for minor procedures (such as cosmetic, skin, dental surgery, or Impella device insertion) or surgery for a serious abdominal infection where the source of infection was successfully treated.
• People who are pregnant or breastfeeding.
• People who are currently taking part in another clinical trial, or who have done so within one month before enrolment.
• For sites in the United States only: people for whom the treating doctor anticipates they will be unable to complete the study or its required procedures for any reason.

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