NCT03271879: ERA-HF

Empagliflozin Versus Placebo on the Rate of Arrhythmic Events in Heart Failure Patients

Status unknown Phase 4 Last updated 25 January 2018

What this trial tests

Phase 4 trial testing Empagliflozin at a dose of 10 mg/day in Heart Failure in 128 participants. Status unknown.

Timeline

15 February 2018

Primary endpoint
1 September 2019

1 June 2020

Quick facts

Lead sponsor	Rambam Health Care Campus
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	128
Start date	15 February 2018
Primary completion	1 September 2019
Estimated completion	1 June 2020

Drugs / interventions tested

• Empagliflozin at a dose of 10 mg/day — full drug profile →

Conditions studied

• Heart Failure — all drugs for Heart Failure →
• Diabetes Mellitus — all drugs for Diabetes Mellitus →
• Arrythmia — all drugs for Arrythmia →

Sponsor

Rambam Health Care Campus — full company profile →

Who can join

18 and older, any sex, with Heart Failure or Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Empagliflozin treatment in high cardiovascular risk patients has been shown to have a relatively rapid powerful capability in reducing cardiovascular mortality. Among the suggested mechanisms mediating this effect of empagliflozin, anti-arrhythmic effect (AAE) has the highest potential to translate into a rapid clinical beneficial effect on cardiovascular mortality, while other mechanisms are known to have a lag in their clinical effect based on data from previous studies. Based on this assumption, the study driving hypothesis is that the effect of empagliflozin on the rate of cardiovascular death may be mediated by a direct effect on the risk for arrhythmic events (via a direct or an indirect effect on the myocardium). The current study aims at assessing the effect of empagliflozin on arrhythmias in diabetic patients with HF with reduced ejection fraction and relatively high arrhythmic burden. The objective of the current study is to demonstrate the effect of empagliflozin compared to placebo on the rate of ventricular arrhythmic events in type 2 diabetes patients with heart failure with reduced ejection fraction and high risk arrhythmic profile.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Non-insulin antihyperglycaemic drugs and heart failure: an overview of current evidence from randomized controlled trials.
   Savarese G, Schrage B, Cosentino F, Lund LH, et al · · 2020 · cited 11× · PMID 32909376 · DOI 10.1002/ehf2.12937
2. Redefining outcomes of ventricular arrhythmia for SGLT2 inhibitor medication in heart failure patients: a meta-analysis of randomized controlled trials.
   Lin M, Zhang S, Zhang L, Yang C, et al · · 2025 · cited 5× · PMID 39893467 · DOI 10.1186/s13643-025-02766-7
3. SAVOR-TIMI to DECLARE-TIMI: A Review on Cardiovascular Outcome Trials of Incretin-modulators and Gliflozins.
   Singh AK, Singh R. · · 2019 · cited 2× · PMID 31161099 · DOI 10.4103/ijem.ijem_12_19
4. Knowledge domain and emerging trends in empagliflozin for heart failure: A bibliometric and visualized analysis.
   Zhang X, Zhang Y, Hu Y. · · 2022 · cited 1× · PMID 36407420 · DOI 10.3389/fcvm.2022.1039348