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:
2025-12-26 @ 11:47 AM
Ignite Modification Date:
2025-12-26 @ 11:47 AM
NCT ID:
NCT03977116
Eligibility Criteria:
Inclusion Criteria:
* heart failure (HF) under optimal maximal drug therapy with NYHA functional II-III;
* HF with prior echocardiographic evidence of left ventricular systolic dysfunction (LVEF \<35 % or subjective assessment of LV dysfunction that is mild or worse);
* patients under furosemide 80 mg daily or less, or equivalent loop diuretic;
* patients with stable HF symptoms for at least 3 months prior to consent;
* patients on stable therapy for HF for at least 3 months prior to consent;
* patients without hospitalization for HF for at least 3 months prior to consent;
* Ischemic and non ischemic dilated cardiomiopathy diagnosis;
* patients with internal cardioverter defibrillator (ICD);
* patients with cardioverter resynchronization therapy and defibrillator (CRTd);
* patients with diagnosis of diabetes mellitus (DM);
* patients aged \>18 years and \<75 years
Exclusion Criteria:
* Patients without ICD;
* patients without previous event of ventricular arrhythmia (VA);
* patients without indication to receive catheter ablation (CA) for VA;
* patients with type 1 diabetes mellitus;
* severe hepatic disease, renal disease defined as chronic kidney disease stage 3b or worse (i.e. glomerular filtration rate \<45 ml/min);
* systolic blood pressure \<95 mmHg at screening visit;
* screening HbA1c \<6.0 %;
* patients unable to walk or to perform cardio pulmonary exercise testing or six minute walking test;
* malignancy (receiving active treatment) or other life threatening diseases;
* pregnant or lactating women;
* patients who have participated in any other clinical trial of an investigational medicinal product within the previous 30 days;
* patients who were unable to give informed consent;
* any other reason considered by a study physician to be inappropriate for inclusion.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03977116
Study Brief:
Protocol Section:
NCT03977116