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 @ 4:27 AM
Ignite Modification Date:
2025-12-25 @ 4:27 AM
NCT ID:
NCT06283420
Eligibility Criteria:
Inclusion Criteria:
* ability to give written informed consent
* Heart failure New York Functional class (NYHA) II-IV with duration more than 3 months (regardless ejection fraction, universal definition of HF)
* NTproBNP more than 125 pg/ml at screening (Universal definition of HF)
* O2 sat more than 90%
Exclusion Criteria:
* Previous SGLT2 inhibitor therapy or i.v., iron therapy in past 3 months (for SGLT2i arm)
* Previous sGC stimulator (for sGC arm), or previous ARNI (for ARNI arm), or previous SGLT2i, sGC or ARNI for control group.
* Coronary artery bypass grafting (CABG), cardiac resynchronisation therapy (CRT), STEMI, valve replacement, in past 3 months, or planned within next 3 months
* Blood loss needing transfusion in past 3 months
* Clinical instability (including HF hospitalization) in the past 1 month
* Myelodysplasia, chronic hemolysis, erythropoetin therapy
* Systemic inflammatory condition (lupus, rheumatoid arthritis...) or infection
* Uncontrolled cancer
* Chronic kidney disease (CKD) grade 4-5
* Severe anemia with Hgb less than 90 g/L
* No chronic exposure to hypoxia (severe chronic obstructive pulmonary disease, obstructive sleep apnoea, long-term oxygen therapy)
* History of SGLT2i allergy or intolerance
* Repeated genitourinary infection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06283420
Study Brief:
Protocol Section:
NCT06283420