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 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT06140251
Eligibility Criteria:
Inclusion Criteria:
1. Provision of signed informed consent prior to any study specific procedures.
2. Male or female, between 40 and 90 years of age.
3. LVEF \<50% on echocardiography or if \>50%, co-existing structural markers of diastolic dysfunction must be present;
* LA width (diameter) ≥3.8 cm or LA length ≥5.0 cm, or LA area ≥20 cm, or LA volume ≥55 mL or LA volume index ≥29 mL/m.
* Left ventricular hypertrophy.
* Markers of diastolic dysfunction as assessed by pulsed wave doppler echocardiography.
* N-terminal pro-B-type natriuretic peptide (NT-proBNP) of at least 125pg per millilitre (or ≥365pg per millilitre if co-existing atrial fibrillation).
4. New York Heart Association (NYHA) class II, III, or IV symptoms.
5. On optimal tolerated evidence-based HF medications.
6. Patients may be ambulatory or recently hospitalized; however, must be \>6 weeks post-discharge on stable diuretic therapy.
Exclusion Criteria:
1. Receiving therapy with an SGLT2 inhibitor \> 6 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor.
2. Severe (eGFR \<20 mL/min/1.73m2), unstable or rapidly progressing renal disease at the time of recruitment.
3. Type 1 diabetes mellitus
4. Recent hospitalisation \< 1 month.
5. Symptomatic hypotension or systolic BP \<95 mmHg at 2 out of 3 measurements
6. Symptomatic bradycardia or second or third-degree heart block without a pacemaker.
7. Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after recruitment.
8. Cardiomyopathy secondary to uncorrected primary valvular disease, infiltrative, arrhythmogenic or right ventricular dysplasia.
9. Significant comorbidity including; pulmonary lung disease requiring home oxygen or non-invasive ventilation, CTEPH or primary pulmonary hypertension.
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
90 Years
Study:
NCT06140251
Study Brief:
Protocol Section:
NCT06140251