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:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT03794518
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of type 2 diabetes according to the ADA criteria.
2. Drug naïve or on stable dose of antidiabetic therapy (oral agents and/or insulin) for 3 months preceding recruitment.
3. Hospitalized for HFpEF (defined as hospitalization require intravenous diuresis) in the 6 months preceding recruitment.
4. eGFR \>60 ml/min
5. LVEF \>50%
6. Presence of LV diastolic dysfunction in echocardiography
We have limited the inclusion criteria in the present study to T2DM patients with HFpEF and evidence of diastolic dysfunction by echocardiography in order to select a homogenous group of HFpEF patients with similar etiology, likely "metabolic HFpEF". We believe that this subgroup of HFpEF will benefit most from treatment with low dose pioglitazone (15 mg) plus dapagliflozin (10 mg).
Exclusion Criteria:
1. Treatment with pioglitazone or SGLT2 inhibitor in the 3 months prior to recruitment.
2. eGFR \< 60 ml/min
3. LVEF \<50%;
4. Valvular heart disease, ASD, VSD
5. Chronic lung disease
6. Cancer
7. diabetes mellitus type 1
8. patients with acute coronary syndrome, stroke or transient ischemic attack in the preceding 6 months
9. pregnancy or lactation period
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03794518
Study Brief:
Protocol Section:
NCT03794518