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 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT03665350
Eligibility Criteria:
Inclusion Criteria:
1. men and women aged ≥70 years;
2. at discharge after admission to hospital for worsening of HF or ambulatory patients with chronic HF;
3. New York Heart Association (NYHA) class II or III
4. with any level of left ventricular ejection fraction;
5. plasma natriuretic peptide (BNP) ≥200 pg/mL or N-terminal pro-BNP ≥900 pg/mL (NT pro-BNP)
6. prior history or newly diagnosed T2DM;
7. candidate by the responsible physician to insulin therapy;
8. signed informed consent.
Exclusion Criteria:
1. significant renal insufficiency (GFR \<30 mL/min/1.73 m2) or severe liver disease (liver function test abnormalities (alanine or aspartate aminotransferase ≥ 3 × upper limit of normal \[ULN\]);
2. levels of hemoglobin \<10 g/dl;
3. HbA1c ≤5% or ≥11%;
4. unstable diabetes: type of diabetes presentation in patients with an anamnesis of frequent episodes of hypoglycemia, hyperglycemic hyperosmolar state, ketoacidosis or lactic acidosis;
5. planned CV surgery or angioplasty in 3 months;
6. any non-cardiac disease that shortens life expectancy to\<1 year (e.g.most cancers);
7. inability to comply with study protocol;
8. participation to another interventional clinical study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
70 Years
Maximum Age:
100 Years
Study:
NCT03665350
Study Brief:
Protocol Section:
NCT03665350