Effect of Dapagliflozin Plus Low Dose Pioglitazone on Hospitalization Rate in Patients With HF and HFpEF

• Status: Not yet recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The prevalence of type 2 diabetes mellitus (T2DM) in Qatar and nations worldwide has increased in recent decades into epidemic proportions. Cardiovascular (CVD) disease is the leading cause of death in T2DM patients. Approximately 80% of T2DM patients will die because of CV cause. Congestive heart failure (CHF) is a major cause of CV death in T2DM, and it also is responsible for significant morbidity and health care expenditure due to high rate of hospitalization for heart failure.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hamad Medical Corporation
• Treatments: Pioglitazone

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