Dapagliflozin in the Treatment of Heart Failure

Active, not recruiting

• Conditions: Heart Failure

• Registration Number: NCT05727423
• Lead Sponsor: Helwan University

Brief Summary

prospectively evaluation the safety and efficacy of the Sodium-glucose Cotransporter-2 (SGLT2) inhibitor dapagliflozin in non-diabetic patients with heart failure and a reduced ejection fraction

Detailed Description

Heart failure (HF) is a complex clinical syndrome characterized by the reduced ability of the heart to pump and/or fill with blood. From a physiological point of view, HF can be defined as an inadequate cardiac output to meet metabolic demands.

HF is a growing public health problem, with an estimated 63 million people affected worldwide , with HF being the underlying cause of more than 1 million hospitalizations every year. These hospitalizations are associated with poor prognosis (50% rate of re-hospitalization within 6 months after discharge and around 33% rate of death within 12 months after discharge), In addition, the prevalence of patient with HF and reduced ejection fraction (HFrEF) is higher and has greater mortality rates than those with preserved ejection fraction (HFpEF).

Sodium-glucose Cotransporter-2(SGLT2) inhibitors are a novel class of anti diabetic agents that promote urinary glucose excretion by inhibiting glucose and sodium reabsorption from the renal proximal tubules and have recently been investigated in several large randomized controlled trials for cardiovascular safety and efficacy in patients with type 2 diabetes .

More recently, the DAPA-HF trial which showed that dapagliflozin significantly improved the outcomes of patients with HFrEF and reduced the risk of the composite outcome of CV death or the worsening of HF versus placebo by 26% irrespective of the presence or absence of T2DM, demonstrated the significance of SGLT2 inhibitors as novel therapeutic agents in heart failure.

In May 2020,The FDA approved AstraZeneca's dapagliflozin (Forxiga) for the treatment of heart failure with reduced ejection fraction (HFrEF) in adults with and without type 2 diabetes (T2D), marking the first time a drug in a class developed for diabetes was approved for heart failure even if diabetes is not present.

This study is established to investigate safety and efficacy of dapagliflozin in non-diabetic patients with heart failure.

Study Timeline

• Study Start: 2021-09-01
• Study First Submitted: 2023-02-05
• Study First Submitted QC: 2023-02-05
• Study First Posted: 2023-02-14
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-25
• Primary Completion: 2024-01-28
• Last Update Posted: 2024-01-29
• Study Completion: 2024-02-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• patients age > 18 years
• Diagnosis of heart failure NYHA class II- IV
• LVEF ≤ 40% on echocardiography

Exclusion Criteria

• Estimated glomerular filtration rate <30 ml/min/1.73m2

  • Pregnant or lactating women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
left ventricular ejection fraction	6 months	Assessment of Echo parameters of LV-systolic function as EF

Secondary Outcome Measures

Name	Time	Method
left ventricular end-systolic volume, left ventricular end-diastolic volume	6 months	Assessment of Echo parameters of LV-systolic function as LVESV, LVEDV
E/e', LAVI, septal e'	6 months	Assessment of Echo parameters of LV- diastolic function as E/e', LAVI, septal e'

Trial Locations

Locations (1)

cardiology department at Ain Shams university hospitals; 🇪🇬 Cairo, Egypt