Phase 4
Completed N=84
Are the "Cardiac Benefits" of Empagliflozin Independent of Its Hypoglycemic Activity? (ATRU-4).
Source: ClinicalTrials.gov NCT03485222 ↗Enrolled (actual)
84
Serious AEs
3.8%
Results posted
Mar 2021
Primary outcomePrimary: Change in Left Ventricle-end Systolic Volume (ESV) — -26.6; -0.5 ml
◆ Published Evidence
Highly cited
518citations · ~104 / year
Randomized Trial of Empagliflozin in Nondiabetic Patients With Heart Failure and Reduced Ejection Fraction.
Summary
Purpose:
The overall hypothesis of the study is that the benefits attained in the EMPA-OUTCOME were, at least in part, mediated by a glucose-independent mechanism. Thus, to demonstrate the existence of the postulated non-glucose dependent effects, the researchers will investigate the safety and efficacy of empagliflozin versus placebo on top of guideline-directed medical therapy in heart failure patients with reduced ejection fraction without diabetes.
Linked Publications (5)
-
Randomized Trial of Empagliflozin in Nondiabetic Patients With Heart Failure and Reduced Ejection Fraction.
-
Mechanistic Insights of Empagliflozin in Nondiabetic Patients With HFrEF: From the EMPA-TROPISM Study.
-
Dipeptidyl peptidase-4 inhibitors, glucagon-like peptide 1 receptor agonists and sodium-glucose co-transporter-2 inhibitors for people with cardiovascular disease: a network meta-analysis.
-
Empagliflozin effects on iron metabolism as a possible mechanism for improved clinical outcomes in non-diabetic patients with systolic heart failure.
-
Anaemia predicts iron homoeostasis dysregulation and modulates the response to empagliflozin in heart failure with reduced ejection fraction: the EMPATROPISM-FE trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Left Ventricle-end Systolic Volume (ESV) |
-26.6; -0.5 | — |
| PRIMARY Change in LV-end Diastolic Volume (EDV) |
-25.1; -1.5 | — |
| SECONDARY Change in LV-Ejection Fraction Index |
6.0; -0.1 | — |
| SECONDARY Change in VO2 Consumption |
1.1; -0.5 | — |
| SECONDARY Change in 6 Min Walk Test |
81; -35 | — |
| SECONDARY Change in Kansas Cardiomyopathy Questionnaire (KCCQ-12) |
21; 1.9 | — |
Eligibility Criteria
Inclusion Criteria
- Patients should meet the following inclusion criteria:
- Ambulatory patients age 18-85 years
- Diagnosis of Heart failure (NYHA II to III)
- LVEF<50% on echocardiography or CMRI in the previous 6 months
- Have stable symptoms and therapy for HF within the last 3 months.
Exclusion Criteria
- Pregnant or lactating women.
- Any history of diabetes by medical history or by any of the established criteria by the American Diabetes Association. It also includes patients with history of diabetes in remission.
- ACS or cardiac surgery within the last 3 months.
- Cancer or any other life-threatening condition.
- Pancreatitis.
- Glomerular Filtration Rate < 45 ml/Kg/min.
- Use of continuous parental inotropic agents.
- Systolic BP < 90 mm Hg.
- Psychiatric disease incompatible with being in study.
- Any contraindication to MRI procedures.
- Any other medical or physical condition considered to be inappropriate by a study physician.
Data sourced from ClinicalTrials.gov (NCT03485222) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.