NCT05776043

Brief Summary

National, multicenter, randomized, double-blind, parallel-group, stratified by SGLT-2 inhibitor type, placebo-controlled trial, - a Phase III study. Primary objective of the study is to investigate the impact of SGLT-2 inhibitors (Empagliflozin and Dapagliflozin) on clinical endpoints in patients hospitalized with acute/decompensated HF.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,364

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Mar 2022

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2022

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2022

Completed
12 months until next milestone

First Posted

Study publicly available on registry

March 20, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 20, 2023

Status Verified

March 1, 2023

Enrollment Period

2.5 years

First QC Date

April 4, 2022

Last Update Submit

March 7, 2023

Conditions

Acute Decompensated Heart Failure

Keywords

SGLT-2 inhibitorsdapagliflozinempagliflozinacute heart failuredecompensated heart failure

Outcome Measures

Primary Outcomes (1)

  • Time to first event of adjudicated cardiovascular (CV) death, or adjudicated hospitalization for heart failure in patients with heart failure with reduced ejection fraction (HFrEF)

    combined endpoint

    at 3 and 9 months

Secondary Outcomes (18)

  • Difference in the number of recurrent hospitalizations due to heart failure between the treatment groups

    at 3 and 9 months

  • Difference in the number of hospitalizations for CV causes between the treatment groups

    at 3 and 9 months

  • Difference in the number of hospitalizations for other than CV causes between the treatment groups

    at 3 and 9 months

  • Time to adjudicated CV death

    at 3 and 9 months

  • Time to adjudicated all cause death

    at 3 and 9 months

  • +13 more secondary outcomes

Study Arms (2)

SGLT 2 Inhibitor

ACTIVE COMPARATOR

Empagliflozin (n=341) or Dapagliflozin (n=341): 9 months of treatment

Drug: Empagliflozin 10 MGDrug: Dapagliflozin 10 MG

Placebo with a switch to SGLT 2 Inhibitor

PLACEBO COMPARATOR

Placebo (n=682) for 3 months of treatment with a subsequent switch to Empagliflozin (n=341) or Dapagliflozin (n=341): 6 months of treatment

Drug: Placebo

Interventions

Empagliflozin 10 MGDRUG

once daily for 6 or 9 months

Also known as: Jardiance
SGLT 2 Inhibitor
Dapagliflozin 10 MGDRUG

once daily for 6 or 9 months

Also known as: Forxiga
SGLT 2 Inhibitor
PlaceboDRUG

once daily for 3 months

Also known as: Placebo with switch to SGLT2 inhibitor
Placebo with a switch to SGLT 2 Inhibitor

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients 18 years of age with the capacity to provide written informed consent
  • Currently hospitalized for a primary diagnosis of acute/decompensated HF (HFrEF, HFmrEF,HFpEF), including symptoms and signs of fluid overload regardless of ejection fraction or diabetes status
  • In patients with HFpEF the diagnosis has to be confirmed according to the current HFpEF definition (by non-invasive testing: evidence of structural or functional changes in the heart as evidenced on echocardiography or by invasive testing as LVEDP assessment or right heart catheterisation).
  • Randomized no earlier than 24 hours and up to 10 days after initial presentation while still hospitalized
  • Stable as defined by: systolic blood pressure (SBP\>100 mmHg for the preceding 6 hours)
  • No intensification of IV diuretics within the last 6 hours,
  • No use of IV vasodilators within the last 6 hours,
  • No use of IV inotropes or levosimendan within the last 24 hours prior to randomization
  • Elevated NT-proBNP \>600 pg/mL during the current hospitalization in patients with HFrEF and \>300 pg/mL in patients with HFmrEF or HFpEF (or above 900 pg/ml if atrial fibrillation is present at admission independently from EF).
  • eGFR \>20 ml/min/1,73m2

You may not qualify if:

  • History of ketoacidosis
  • Type 1 diabetes
  • SGLT-2 Inhibitor at baseline or known allergy to SGLT-2 Inhibitors
  • Current active cancer with less than 2 years of life expectancy
  • Pulmonary embolism, cerebrovascular accident as the primary trigger for the current hospitalization
  • Cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases (e.g. haemochromatosis, Fabry disease), muscular dystrophies, cardiomyopathy with reversible causes (e.g. stress cardiomyopathy), hypertrophic obstructive cardiomyopathy or known pericardial constriction
  • Any severe (obstructive or regurgitant) valvular heart disease, expected to lead to surgery during the trial period
  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant
  • Blood pH\<7.32
  • \>1 episode of severe hypoglycaemia within the last 6 months under treatment with insulin or sulfonylurea
  • Acute symptomatic urinary tract infection or genital infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Autonomous Public Specialist Western John Paul II Hospital

Grodzisk Mazowiecki, Poland

RECRUITING

MeSH Terms

Interventions

empagliflozindapagliflozin

Central Study Contacts

Prof. Marek Postula, MD PhD

CONTACT

0048 22 1166160mpostula@wum.edu.pl

Prof. Jolanta M. Siller-Matula, MD PhD

CONTACT

Jolanta.Siller-Matula@meduniwien.ac.at

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
double blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two arms with a subsequent stratification based on the SGLT2 inhibitor type.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2022

First Posted

March 20, 2023

Study Start

March 15, 2022

Primary Completion

September 30, 2024

Study Completion

December 31, 2025

Last Updated

March 20, 2023

Record last verified: 2023-03

Locations

PL(1)