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Empagliflozin for New On-set Heart Failure Study Regardless of Ejection Fraction (EMPA)

Primary Purpose

Acute Heart Failure

Status

Recruiting

Phase

Phase 3

Locations

Hong Kong

Study Type

Interventional

Intervention

Empagliflozin 10 MG

About this trial

This is an interventional treatment trial for Acute Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subject age >18 hospitalized for primary diagnosis of acute HF
Dyspnoea (exertional or at rest) and 2 of the following signs: Congestion on chest X-ray; Rales on chest auscultation; Clinically relevant oedema (e.g. ≥1+ on a 0 to 3+ scale); Elevated jugular venous pressure
Stabilization criteria (while in the hospital): systolic blood pressure ≥100mmHg and no symptoms of hypotension in the preceding 24 hours; No increase in i.v. diuretic dose for 24 h prior; No i.v. vasodilators including nitrates within the last 24 h prior; No i.v. inotropic drugs for 24 h prior
NT-proBNP ≥1600 pg/mL or BNP ≥400 pg/mL. (Patients with atrial fibrillation: NT-proBNP ≥2400 pg/mL or BNP
≥600 pg/mL. Measured during index hospitalization
Heart failure hospitalization that requires the treatment of a minimum single dose of 40 mg of i.v.

furosemide( or Equivalent i.v loop diuretics defined as 20 mg of torsemide or 1mg of bumetanide)

Exclusion Criteria:

Cardiogenic shock
Documented history of HF with previous HF admission
Current hospitalization for acute HF primarily triggered by pulmonary embolism, cerebrovascular accident, or acute myocardial infraction
Interventions in the past 30 days prior or planned during the study: Major cardiac surgery, or Transcatheter aortic valve implantation (TAVI), or percutaneous coronary intervention (PCI), or MitraClip; Implantation of cardiac resynchronization therapy device; Cardiac mechanical support implantation
Current or expected heart transplant, left ventricular assist device (LVAD), intraaortic balloon pumping (IABP), or patients with planned inotropic support in an outpatient setting
Haemodynamically severe uncorrected primary cardiac valvular disease planned for surgery or intervention during the course of the study
eGFR <20 mL/min/1.73m2 as measured during index hospitalization (latest measurement before randomization) or patients requiring dialysis
Type 1 diabetes mellitus (DM)
History of ketoacidosis, including diabetic ketoacidosis
Current or prior treatment with SGLT2 inhibitors in the 90 days prior to enrolment.

Sites / Locations

The Chinese University of Hong KongRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Empagliflozin 10 MG

Arm Description

Outcomes

Primary Outcome Measures

Heart failure (HF) events

Number of heart failure events (including hospitalization for HFs, urgent heart failure visits and unplanned outpatient visits), time to first heart failure event.

All-cause mortality

All-cause mortality after 90 days of treatment

Secondary Outcome Measures

Change in Kansas City Cardiomyopathy Questionnaire - Total Symptom Score (KCCQ-TSS)

Change from baseline in KCCQ-TSS. Scores are transformed to a range of 0-100, where higher scores reflect better health status.

NT-proBNP level

Change from baseline in log-transformed NT-proBNP level

New York Heart Association (NYHA) class

Change in NYHA class (I-IV), Class IV is most severe; Class I least severe

Major Adverse Cardiovascular Event (MACE)

Measure the occurrence of MACE, including Days alive and out of hospital, occurrence of hypertensive Heart failure from study drug initiation until 90 days after initial hospital discharge and randomization; Time to first occurrence of cardiovascular death or heart failure event until end of trial visit

Occurrence of kidney damage

Occurrence of chronic dialysis or renal transplant or sustained reduction of ≥40% estimated glomerular filtration rate (eGFR), or Sustained eGFR <15mL/min/1.73m2 for patients with baseline eGFR ≥30 mL/min/1.73m2 Sustained eGFR <10mL/min/1.73m2 for patients with baseline eGFR <30 mL/min/1.73m2.

Weight loss

Weight loss per mean daily loop diuretic dose after 15, 30, 60 and 90 days of treatment.

Quality-adjusted life years (QALY) gained

Quality-adjusted life years (QALY) gained due to early initiation of empagliflozin

Change in 6 minute hall walk (6MHW)

Change from baseline in 6MHW result

Full Information

NCT ID

NCT05556044

First Posted

September 15, 2022

Last Updated

October 2, 2022

Sponsor

Chinese University of Hong Kong

1. Study Identification

Unique Protocol Identification Number

NCT05556044

Brief Title

Empagliflozin for New On-set Heart Failure Study Regardless of Ejection Fraction

Acronym

EMPA

Official Title

In-hospital Initiation of Empagliflozin for the Treatment of New-onset Acute Heart Failure Regardless of Ejection Fraction: A Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 27, 2022 (Actual)

Primary Completion Date

February 28, 2024 (Anticipated)

Study Completion Date

May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

Brief Summary

Heart failure (HF) is one of the most important reasons for hospital admission and is associated with high mortality and morbidity. After discharge, up to 40% of patients are readmitted within 6 months and 1-year post-discharge mortality is high. The cost burden of treating patients with HF is high and ~80% of healthcare costs are related to hospital admissions. Sodium-glucose cotransporter-2 (SGLT2) inhibitor is considered one of the four foundational therapies (ACE-I or ARNI, beta-blockers, MRA, and SGLT2 inhibitors) for HFrEF. In particular, empagliflozin has been shown in randomized controlled trials to reduce the combined risk of cardiovascular death or HF hospitalization in HF patients with both reduced ejection fraction (HFrEF) and preserved ejection fraction (HFpEF). However, guidelines do not specify the sequence and the timing of which therapy to be commenced. The timing of SGLT inhibitors initiation in the treatment of acute HF is not established. In particular, new-onset acute HF is a group which is understudied in the major trials to date. This study aims to evaluate the efficacy and safety of in-hospital initiation of empagliflozin in patients hospitalized for new onset acute HF, regardless of LVEF for up to 90 days of follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Heart Failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Empagliflozin 10 MG

Arm Type

Other

Intervention Type

Drug

Intervention Name(s)

Empagliflozin 10 MG

Intervention Description

This is an investigator-initiated, prospective, single-centre, non-randomized open label study that evaluates the efficacy and safety of initiating empagliflozin during index hospitalization for acute heart failure regardless of LVEF.

Primary Outcome Measure Information:

Title

Heart failure (HF) events

Description

Number of heart failure events (including hospitalization for HFs, urgent heart failure visits and unplanned outpatient visits), time to first heart failure event.

Time Frame

90 days

Title

All-cause mortality

Description

All-cause mortality after 90 days of treatment

Time Frame

90 days

Secondary Outcome Measure Information:

Title

Change in Kansas City Cardiomyopathy Questionnaire - Total Symptom Score (KCCQ-TSS)

Description

Change from baseline in KCCQ-TSS. Scores are transformed to a range of 0-100, where higher scores reflect better health status.

Time Frame

90 days

Title

NT-proBNP level

Description

Change from baseline in log-transformed NT-proBNP level

Time Frame

90 days

Title

New York Heart Association (NYHA) class

Description

Change in NYHA class (I-IV), Class IV is most severe; Class I least severe

Time Frame

90 days

Title

Major Adverse Cardiovascular Event (MACE)

Description

Time Frame

90 days

Title

Occurrence of kidney damage

Description

Time Frame

90 days

Title

Weight loss

Description

Weight loss per mean daily loop diuretic dose after 15, 30, 60 and 90 days of treatment.

Time Frame

90 days

Title

Quality-adjusted life years (QALY) gained

Description

Quality-adjusted life years (QALY) gained due to early initiation of empagliflozin

Time Frame

90 days

Title

Change in 6 minute hall walk (6MHW)

Description

Change from baseline in 6MHW result

Time Frame

90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject age >18 hospitalized for primary diagnosis of acute HF Dyspnoea (exertional or at rest) and 2 of the following signs: Congestion on chest X-ray; Rales on chest auscultation; Clinically relevant oedema (e.g. ≥1+ on a 0 to 3+ scale); Elevated jugular venous pressure Stabilization criteria (while in the hospital): systolic blood pressure ≥100mmHg and no symptoms of hypotension in the preceding 24 hours; No increase in i.v. diuretic dose for 24 h prior; No i.v. vasodilators including nitrates within the last 24 h prior; No i.v. inotropic drugs for 24 h prior NT-proBNP ≥1600 pg/mL or BNP ≥400 pg/mL. (Patients with atrial fibrillation: NT-proBNP ≥2400 pg/mL or BNP ≥600 pg/mL. Measured during index hospitalization Heart failure hospitalization that requires the treatment of a minimum single dose of 40 mg of i.v. furosemide( or Equivalent i.v loop diuretics defined as 20 mg of torsemide or 1mg of bumetanide) Exclusion Criteria: Cardiogenic shock Documented history of HF with previous HF admission Current hospitalization for acute HF primarily triggered by pulmonary embolism, cerebrovascular accident, or acute myocardial infraction Interventions in the past 30 days prior or planned during the study: Major cardiac surgery, or Transcatheter aortic valve implantation (TAVI), or percutaneous coronary intervention (PCI), or MitraClip; Implantation of cardiac resynchronization therapy device; Cardiac mechanical support implantation Current or expected heart transplant, left ventricular assist device (LVAD), intraaortic balloon pumping (IABP), or patients with planned inotropic support in an outpatient setting Haemodynamically severe uncorrected primary cardiac valvular disease planned for surgery or intervention during the course of the study eGFR <20 mL/min/1.73m2 as measured during index hospitalization (latest measurement before randomization) or patients requiring dialysis Type 1 diabetes mellitus (DM) History of ketoacidosis, including diabetic ketoacidosis Current or prior treatment with SGLT2 inhibitors in the 90 days prior to enrolment.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Daniel Xu

Phone

35051518

Ext

1518

danielxu@cuhk.edu.hk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bryan Yan

Organizational Affiliation

Chinese University of Hong Kong

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Chinese University of Hong Kong

City

Shatin

ZIP/Postal Code

999077

Country

Hong Kong

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Daniel Xu

Phone

35051518

Ext

1518

danielxu@cuhk.edu.hk

12. IPD Sharing Statement

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Empagliflozin for New On-set Heart Failure Study Regardless of Ejection Fraction

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