UnknownPhase 3

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

Qatar648 participantsStarted 2019-03

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Time to first hospitalization for heart failure after starting intervention

Timeframe: 3 years

Trial details

NCT IDNCT03794518

SponsorHamad Medical Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-09

Contact for this trial

Nidal Asaad, MD

44395578 nasaad@hamad.qa

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