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:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT04633005
Eligibility Criteria:
Inclusion Criteria:
* Adults age \> = 18 years
* HF with left ventricular ejection fraction \<= 40% within 3 months of screening who are not on target dose guideline directed medical therapy
* New York Heart Association class II, III, or IV symptoms
Exclusion Criteria:
* Age \< 18
* Systolic blood pressure \< 110 mm Hg at enrollment if not on HTN therapy.
* Systolic blood pressure \<100 mm Hg at enrollment if on HTN therapy
* Serum creatinine \>2.5 for men and 2.0 for women
* Serum potassium \> 5.0 mEq/L
* Current need for inotropes
* Cardiac index \< 2.2 L/min/m2
* History of revascularization within 30 days or plan for revascularization
* History of type 1 diabetes mellitus
* History of allergic reaction or contraindication to a beta-blocker (BB), mineralocorticoid receptor antagonist (MRA), or sodium glucose cotransporter 2 inhibitor (SGLT2i)
* Contraindication to receive any of the components of the polypill
* Pregnancy
* \< 6 month expected survival
* Inability to provide written informed consent
* Persistent or permanent atrial fibrillation who may not have optimal MRI imaging
* Extreme obesity (BMI \> 45 kg/m2)
* ICD/Pacemaker devices that are incompatible with MRI
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04633005
Study Brief:
Protocol Section:
NCT04633005