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 @ 10:19 PM
Ignite Modification Date:
2025-12-24 @ 10:19 PM
NCT ID:
NCT04197635
Eligibility Criteria:
Inclusion Criteria:
* The participant or his legal representative is willing and able to give informed consent for participation in the study.
* Male or female, aged ≥18 years.
* Established documented diagnosis of symptomatic HF (NYHA functional class II-III), which has been present for at least 2 months.
* LVEF ≤40% documented in the last 3 months by echocardiography or cardiac magnetic resonance.
* NT-proBNP ≥600 pg/ml.
* Patients should receive background standard of care for HFrEF at judgment of the investigator.
* Estimated glomerular filtration rate (eGFR) ≥30 ml/min/1.73m2 (DMRD formula) at enrolment.
Exclusion Criteria:
* Inability to perform a valid (respiratory exchange ratio -RER- ≥1.05) baseline cardiopulmonary exercise test (CPET)
* Patients receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment, or previous intolerance of an SGLT2 inhibitor
* Type 1 diabetes
* Symptomatic hypotension or systolic blood pressure \<95 mmHg
* Current acute decompensated HF or hospitalization due to decompensated HF \<4 weeks prior to enrolment
* Myocardial infarction, unstable angina, stroke, or transient ischemic attack within 12 weeks prior to enrolment
* Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or cardiac valve repair/replacement within 12 weeks prior to enrolment, or planned to undergo any of these operations after randomization
* Implantation of a cardiac resynchronization therapy (CRT) device within 12 weeks prior to enrolment or intent to implant a CRT device
* Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
* HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy, or uncorrected severe primary cardiac valve disease
* Symptomatic bradycardia or second or third-degree heart block without a pacemaker
* Severe renal dysfunction (eGFR\<30 ml/min/1.73m2) or prior admission for acute renal failure in the last 4 weeks.
* Pregnant or lactating women
* Woman of childbearing age, unless they are using highly effective contraceptive methods.
* Patients with severe hepatic impairment (Child-Pugh class C).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT04197635
Study Brief:
Protocol Section:
NCT04197635