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 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT01787851
Eligibility Criteria:
Inclusion Criteria:
Patients will be eligible for inclusion in this protocol if they satisfy the following criteria:
1. DCM with left ventricular ejection fraction (LVEF) ≤40%
2. New York Heart Association (NYHA) class III-IV symptoms
3. age ≥18
4. an indwelling PA catheter
5. and an anticipated clinical requirement for a PA catheter for at least five days.
Exclusion Criteria:
Patients will be ineligible for inclusion in this protocol if they have any of the following:
1. urgent (\<6 hr) need for (or increase in) inotropic support (INTERMACS profile 1)
2. diabetes mellitus
3. known disorder of the respiratory chain or mitochondrial cardiomyopathy
4. significant hyperlipidemia with triglyceride value \>300mg/dL
5. normal cardiac index (\>2.5L/min/m2) on initial right heart catheterization
6. indwelling intra-aortic balloon pump
7. chronic liver disease
8. severe renal dysfunction (CKD stage IV-V) with creatinine clearance \<30 mL/min/1.73m2
9. more than moderate valvular stenosis or regurgitation
10. pregnancy or breastfeeding
11. peripartum cardiomyopathy diagnosed within the past year
12. inability to provide informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01787851
Study Brief:
Protocol Section:
NCT01787851