Authors
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GMC AND SSH NAGPUR -More
Category
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Primary study
Registry of Trials»Clinical Trials Registry - India
Year
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2026
INTERVENTION: Intervention1: Emphagliflozin and GDMT: Intervention Arm Group A Empagliflozin and GDMT: Patients randomized to this arm will receive Empagliflozin 10 mg, oral tablet, once daily, in addition to standard guideline‐directed medical therapy GDMT for heart failure. Empagliflozin will be continued throughout the 12‐month follow‐up period unless discontinued due to intolerance, adverse events, or withdrawal of consent. Dose adjustment or discontinuation will be at the discretion of the treating physician based on renal function, hemodynamic status, and tolerability, per standard prescribing guidelines. Background Therapy ,both arms All participants, regardless of allocation, will continue to receive guideline‐directed medical therapy for heart failure as clinically indicated e.g., beta‐blockers, ACE inhibitors/ARBs/ARNI, mineralocorticoid receptor antagonists, diuretics, optimized per treating physician judgement and current HF guidelines. Control Intervention1: GDMT alone: Group B ‐ standard guideline‐directed medical therapy GDMT Patients randomized to this arm will continue GDMT as above without addition of an SGLT2 inhibitor for the duration of the study. Route of Administration: Oral CONDITION: Health Condition 1: I509‐ Heart failure, unspecified PRIMARY OUTCOME: TIME TO FIRST HOSPITALISATION OR ; CARDIOVASCULAR DEATHTimepoint: Baseline,1month,3month,6month and 12 months SECONDARY OUTCOME: TOTAL HF HOSPITALISATIONS ; ALL CAUSE MORTALITY ; CHANGE IN EGFR ; CHANGE IN KCCQ SCORE ; NYHA CLASS IMPROVEMENT ; SAFTEY OUTCOMES HYPOTENSION,AKI,GENITAL INFECTIONTimepoint: At baseline,1month,3 month,6 month & 12 months INCLUSION CRITERIA: ANY DOCUMENTED VALVULAR HEART DISEASE NATIVE OR POST INTERVENTION CHRONIC HEART FAILURE ANY LVEF STABLE ON GDMT
Epistemonikos ID: 1ebf3e7a489c14f34ae009ef7e7a96c859c10f26
First added on: Oct 08, 2026