Status:
UNKNOWN
Effect of Dapagliflozin Plus Low Dose Pioglitazone on Hospitalization Rate in Patients With HF and HFpEF
Lead Sponsor:
Hamad Medical Corporation
Conditions:
Risk Reduction
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief 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 i...
Detailed Description
Community based studies have demonstrated similar prevalence of HF with reduced ejection fraction (HFpEF) and HF with reduced LV function (HFrEF) in patients hospitalized for CHF. Moreover, the preval...
Eligibility Criteria
Inclusion
- Diagnosis of type 2 diabetes according to the ADA criteria.
- Drug naïve or on stable dose of antidiabetic therapy (oral agents and/or insulin) for 3 months preceding recruitment.
- Hospitalized for HFpEF (defined as hospitalization require intravenous diuresis) in the 6 months preceding recruitment.
- eGFR \>60 ml/min
- LVEF \>50%
- 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
- Treatment with pioglitazone or SGLT2 inhibitor in the 3 months prior to recruitment.
- eGFR \< 60 ml/min
- LVEF \<50%;
- Valvular heart disease, ASD, VSD
- Chronic lung disease
- Cancer
- diabetes mellitus type 1
- patients with acute coronary syndrome, stroke or transient ischemic attack in the preceding 6 months
- pregnancy or lactation period
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
648 Patients enrolled
Trial Details
Trial ID
NCT03794518
Start Date
March 1 2019
End Date
December 1 2021
Last Update
January 7 2019
Active Locations (1)
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1
Heart Hospital, Hamad Medical Coorporation
Doha, Qatar, 3050