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 @ 10:08 PM
Ignite Modification Date:
2025-12-24 @ 10:08 PM
NCT ID:
NCT05508035
Eligibility Criteria:
Inclusion Criteria:
* Written consent to participate in the study, expressed prior to any procedures related to the study.
* Age 18 and over.
* Symptomatic HF in NYHA class II to IV of ischemic etiology.
* Left ventricular ejection fraction at screening visit ranged from 40-49%.
* Elevated concentration of NT-proBNP natriuretic peptide ≥125 pg/ml.
* Features of a structural / functional disease of the left ventricle.
* Optimal pharmacotherapy with ACEI or ARB and beta-blocker, unless they are contraindicated.
Exclusion Criteria:
* History of hypersensitivity or allergy to any of the drugs tested or drugs of similar chemical class, ACEIs, ARBs or neprilysin inhibitors.
* Previous history of intolerance to recommended ACEI or ARB target doses.
* Known history of angioedema.
* Requirement of simultaneous treatment with ACEI and ARB.
* Acute decompensated HF within 6 weeks prior to screening visit.
* Symptomatic hypotension systolic blood pressure \<100 mmHg at screening visit.
* Current or previous treatment with sacubitril / valsartan.
* Estimated creatinine clearance \<30 ml / min / 1.73 m2 at screening visit.
* Serum potassium \>5.2 mmol / L at screening visit.
* Acute coronary syndrome or elective revascularization within 6 weeks prior to screening.
* Stroke, transient ischemic attack, carotid angioplasty, heart surgery, or any other major cardiovascular surgery in the 3 months prior to screening.
* Implantation of a cardioverter defibrillator, pacemaker, or resynchronization therapy device incompatible with MRI.
* Fixed atrial fibrillation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05508035
Study Brief:
Protocol Section:
NCT05508035