Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT06253104
Eligibility Criteria:
Inclusion Criteria:
1. Over 18 years of age
2. Ejection fraction \<40%
3. Cardiogenic shock defined by clinical criteria (including any of: lactate \>2.5 mmol/L, systolic blood pressure \<90 mmHg, acute kidney or liver injury, or cardiac index \<2.1 on hemodynamic monitoring) plus the clinical requirement for at least one pressor, inotrope, or temporary mechanical circulatory support device (MCSD)
Exclusion Criteria:
1. History of LVAD or other durable ventricular assist device
2. An identified clinical disorder associated with skeletal muscle weakness/wasting (e.g., muscular dystrophy, mitochondrial disorder, active cancer, modified Rankin score greater or equal to 4 post-stroke
3. Chronic enteric and parenteral nutrition support patients
Intubation or prior history of heart transplantation are not exclusion criteria if the inclusion criteria are otherwise met.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT06253104
Study Brief:
Protocol Section:
NCT06253104