This study tests empagliflozin in patients with chronic heart failure with reduced ejection fraction (HFrEF). The study looks at how far patients can walk in 6 minutes and at their heart failure symptoms
- Conditions
- Chronic Heart Failure with reduced Ejection Fraction (HFrEF)MedDRA version: 20.0Level: LLTClassification code 10011949Term: Decompensation cardiacSystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2017-004073-14-IT
- Lead Sponsor
- BOEHRINGER-INGELHEIM ITALIA S.P.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 707
1. Of full age of consent (according to local legislation, usually = 18
years) at screening.
2. Male or female patients. Women of childbearing potential (WOCBP)1
must be ready and able to use highly effective methods of birth control
per ICH M3 (R2) that result in a low failure rate of less than 1% per year
when used consistently and correctly. A list of contraception methods
meeting these criteria is provided in the patient information.
3. Signed and dated written informed consent in accordance with ICHGCP
and local legislation prior to admission to the trial
4. 6MWT distance =350 m at screening and at baseline.
5. Patients with chronic HF diagnosed for at least 3 months before Visit 1
and currently in NYHA class II-IV
6. Chronic HF with reduced EF defined as LVEF = 40 % as per
echocardiography at Visit 1 as per local reading (obtained under stable
condition).
7. Elevated NT-proBNP > 450 pg/ml for patients without atrial fibrillation (AF) OR NT-proBNP > 600 pg/ml for patients with AF as analysed at the Central laboratory at Visit 1
8. Patients must be clinically stable and on appropriate and stable dose
of medical therapy for HF (such as ACEi, ARB, ß-blocker, oral diuretics,
MRA, ARNI, ivabradine), consistent with prevailing CV guidelines, stable
for at least 4 weeks prior to Visit 1(screening) with the exception of
diuretics which must have been stable for at least two weeks prior to
Visit 1. The investigator must document the reason in case the patient is not on such medication or if not on target dose of any heart failure medication as per local guidelines.
9. Clinically stable at randomization with no signs of heart failure
decompensation (as per investigator judgement).
10. Appropriate use of medical devices such as cardioverter defibrillator
(ICD) or a cardiac resynchronization therapy (CRT) consistent with
prevailing local or international CV guidelines, and if a device is required,
it must have been implanted for at least 3 months prior to visit 1 for CRT
and 1 month prior to visit 1 for ICD.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 280
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
1. Myocardial infarction (increase in cardiac enzymes in combination
with symptoms of ischaemia or newly developed ischaemic ECG
changes), coronary artery bypass graft surgery or other major
cardiovascular surgery, stroke or TIA in past 90 days prior to Visit 1
2. Acute decompensated HF (exacerbation of chronic HF) requiring
intravenous (i.v.) diuretics, i.v. inotropes or i.v. vasodilators, or left
ventricular assist device within 4 weeks prior to Visit 1, and/or during
screening period until Visit 2
3. Previous or current randomisation in another Empaglifozin Heart Failure
trial (i.e. studies 1245.110, 1245.121, 1245-0167)
4. Type 1 Diabetes Mellitus (T1DM)
5. Impaired renal function, defined as eGFR < 20 mL/min/1.73 m2
(CKD-EPIcr) or requiring dialysis, as determined at Visit 1
6. Symptomatic hypotension or a SBP < 100 mmHg at Visit 1 or 2
7. Systolic blood pressure (SBP) = 180 mmHg at Visit 1 or 2, or SBP
>160mmHg at both Visit 1 and 2
8. Atrial fibrillation or atrial flutter with a resting heart rate >110 bpm
documented by ECG at Visit 1 (Screening)
9. Unstable angina pectoris in past 30 days prior to Visit 1
10. Largest distance walked in 6 minutes (6MWTD) at baseline <100m.
11. Any presence of condition that precludes exercise testing such as:
- claudication,
- uncontrolled (according to investigator judgement) bradyarrhythmia or
tachyarrhythmia,
- significant musculoskeletal disease,
- primary pulmonary hypertension,
- severe obesity (body mass index =40.0 kg/m2),
- orthopedic conditions that limit the ability to walk (such as arthritis in
the leg, knee or hip injuries)
- amputation with artificial limb without stable prosthesis function for
the past 3 months
- Any condition that, in the opinion of the investigator, would
contraindicate the assessment of 6MWT
12. Patients in a structured (according to Investigator judgement)
exercise training program in the 1 month prior to screening or planned
to start one during the course of this trial.
13. Planned implantation of ICD or CRT during the course of the trial.
14. Treatment with i.v. iron therapy or erythropoietin within 3 months
prior to screening
15. Treatment with i.v. iron therapy or erythropoietin within 3 months
prior to screening
16. Further exclusion criteria applies
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method