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    The value 'Show more Show more Revision: v2.9.0' has been updated to 'Show less MedlinePlus related topics: Heart Failure Drug Information available for: Pioglitazone Pioglitazone hydrochloride FDA Drug and Device Resources Show less Design Details Primary Purpose : Health Services Research Allocation : Randomized Interventional Model : Parallel Assignment Interventional Model Description: Pioglitazone (15 mg) and dapagliflozin (10mg) vs Placebo Masking : Single ( Participant ) Masking Description: Random process Arms and Interventions Participant Group/Arm Intervention/Treatment Experimental : Pioglitazone Plus dapaglifliozin Pioglitazone 15mg and dapagliflozin 10mg together in T2DM patients having HF and HFpEF conditions Drug : Pioglitazone Plus dapaglifliozin Pioglitazone Plus dapagliflozin Placebo Comparator : Placebo Beta blockers, ACEI, ARB, and aldosterone Drug : Placebo (Beta blockers, ACEI, ARB, and aldosterone ) Primary Outcome Measures Outcome Measure Measure Description Time Frame Time to first hospitalization for heart failure after starting intervention Hospitalization for heart failure will be defined as a hospitalization >24 hours requiring intravenous diuretic infusion. 3 years Secondary Outcome Measures Outcome Measure Measure Description Time Frame Number of all cause mortality Composite outcome comprised of total mortality, incidence of acute coronary syndrome and non fatal CVA 3 years Additional Relevant MeSH Terms Hypoglycemic Agents Physiological Effects of Drugs Pioglitazone Plan to Share Individual Participant Data (IPD)? No Studies a U.S. FDA-Regulated Drug Product No Studies a U.S. FDA-Regulated Device Product No Revision: v2.9.1
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