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 @ 6:37 PM
Ignite Modification Date:
2025-12-24 @ 6:37 PM
NCT ID:
NCT03226457
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of NYHA Functional class II-III HF with prior echocardiographic evidence of LVSD.
* On stable doses of furosemide, or alternative loop diuretic for at least one month.
* Stable Type 2 Diabetes (HbA1c, in the last 3 months, of 6.5% ≤ and ≤10.0%)
* eGFR ≥ 45 ml/min.
* Have stable HF symptoms for at least three months prior to consent
* On stable HF therapy for at least three months prior to consent
* Have not been hospitalised for HF for at least three months prior to consent.
* Women of childbearing potential must agree to take precautions to avoid pregnancy throughout the trial and for 4 weeks after intake of the last dose.
Exclusion Criteria:
* A diagnosis of chronic liver disease and/or liver enzymes that are twice the upper limit of normal
* Systolic BP of \<95mmHg at screening visit.
* Participants on thiazide diuretics.
* Participants receiving renal dialysis
* Participants who have previously had an episode of diabetic ketoacidosis.
* Participants with type 1 diabetes mellitus
* Malignancy (receiving active treatment) or other life threatening disease.
* Pregnant or lactating women
* Participants with difficulty in micturition e.g. severe prostate enlargement
* Allergy to any SGLT2 inhibitor or lactose or galactose intolerance
* Past or current treatment with any SGLT2 inhibitor
* Participants who have participated in any other clinical interventional trial of an investigational medicinal product within 30 days.
* Participants who are unable to give informed consent
* Any other reason considered by the physician to be inappropriate for inclusion.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03226457
Study Brief:
Protocol Section:
NCT03226457