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 @ 10:40 PM
Ignite Modification Date:
2025-12-24 @ 10:40 PM
NCT ID:
NCT05236335
Eligibility Criteria:
Inclusion Criteria:
* Type 2 diabetes
* LVEF \> 40 %
* a clinical diagnosis of HFpEF and/or left ventricular hypertrophy (posterior wall thickness \> 12 mm) and/or previous myocardial infarction
* age ≥ 18 years old,
* one of the following criteria (a-d) should be fulfilled:
1. Echocardiographic signs of diastolic dysfunction E/e' \> 8
2. Septal e ́\< 7 cm/s and/or lateral e ́ \< 10 cm/s
3. Left atrium volume index ≥34 mL/m2 and/or left atrial diameter \> 4 cm
4. NT-proBNP \> 125 pg/ml.
Exclusion Criteria:
* Insulin treatment, inability to give informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05236335
Study Brief:
Protocol Section:
NCT05236335