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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
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
September 15, 2022
Last Updated
October 2, 2022
Sponsor
Chinese University of Hong Kong
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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
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

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
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
Time Frame
90 days
Title
Occurrence of kidney damage
Description
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.
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
No
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
Email
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
Email
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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