Primary:The primary objective of this trial is to evaluate whether empagliflozin 10mg/day will relieve dyspnea, improves diuretic response, decreases length of initial hospital stay and NT-proBNP compared to placebo during hospital admission for…
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
a) Dyspnea relief, assessed by VAS at baseline to day 4 (or discharge if
earlier);
b) Diuretic response (defined as * weight kg/[(total i.v. dose)/40mg]+[(total
oral dose)/80mg)] furosemide (or equivalent loop diuretic dose) up to day 4) c)
Length of initial hospital stay;
d) Change in NT-proBNP from baseline to day 4 (or discharge if earlier)
Secondary outcome
Death and/or heart failure re-admission through day 60
Change in plasma values of renal function, including creatinine, eGFR,
cystatin C, BUN, renal biomarkers and hemoglobin, hematocrit, albumin from
baseline to day 4 (or discharge if earlier) or day 30
Change in urinary renal biomarkers to day 4 or day 30
Background summary
Acute decompensated heart failure is one of the fastest growing diseases in the
world and athe leading cause of hospital admissions worldwide. Short term
mortality and rehospitalization are extremely high (20-30% within 3-6 months).
There is no therapy available that improves clinical outcome of these patients.
Therefore, there is a very high unmet need to find effective treatments in
patients with acute decompensated heart failure. Despite treatment with loop
diuretics, many patients are discharged with residual congestion, which is
related to a higher risk of early rehospitalization and death. Renal Failure
and worsening renal function in patients with AHF is common and related to an
impaired outcome. Empagliflozin is a selective inhibitor of sodium glucose
co-transporter with diuretic and renal protective properties. Recently,
empagliflozin reduced the risk of cardiovascular outcome and of death from any
cause in patients with type 2 diabetes at high risk for cardiovascular events.
Interestingly, hospitalization for heart failure was reduced by 35% and risk of
progression of nephropathy by 44 %. We hypothesize that the reduction in the
risk of hospitalization for heart failure was caused by the diuretic and renal
protective properties of empagliflozin and that empagliflozin is therefore
beneficial for the treatment of patients who are hospitalized for acute
decompensated heart failure.
Study objective
Primary:
The primary objective of this trial is to evaluate whether empagliflozin
10mg/day will relieve dyspnea, improves diuretic response, decreases length of
initial hospital stay and NT-proBNP compared to placebo during hospital
admission for acute decompensated heart failure.
Secondary Objective:
The secondary objectives of this trial are to evaluate the effects of
empagliflozin on change in dyspnea, renal function, and NT-proBNP and on
30-day death and/or heart failure hospital.
Safety Objectives: The safety objectives of this trial are to evaluate whether
empagliflozin is well tolerated, and does not cause an excess number of
(serious) adverse events. Specific attention will be paid to hypotension, renal
dysfunction, keto-acidosis and/ or hyperosmolar hyperglyaecemic syndrome.
Study design
Multicenter, prospective, double-blind, placebo controlled, parallel design,
interventional, pilot study
Intervention
Empagliflozine 1 dd 10 mg versus placebo (matching) for 30 days
Study burden and risks
Patients need to take the study medication and come to one research visit after
hospitalisation
Side effects include hypoglycemia, itching, olguria, blood pressure drop and
genital infections. Rare cases of (severe) diabetic keto-acidosis have been
reported. Additionally, possible (extra) venapunctures for blood sampling
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
1. Male or female >18 years of age;
2. Hospitalized for AHF; AHF is defined as including all of the followings measured at any time between presentation (including the emergency department) and the end of screening:
a. Dyspnea at rest or with minimal exertion
b. Signs of congestion, such as edema, rales, and/or congestion on chest radiograph
c. BNP *350 pg/mL or NT-proBNP *1,400 pg/mL (for patients with AF: BNP*500 pg/mL or NT-proBNP *2,000 pg/mL)
d. Treated with loop diuretics at screening
3. Able to be randomized within 24 hours from presentation to the hospital
4. Able and willing to provide freely given written informed consent
5. eGFR (CKD-EPI) *30 ml/min/1.73m2 between presentation and randomization
Exclusion criteria
1. Diabetes Mellitus Type I
2. Dyspnea primarily due to non-cardiac causes
3. Cardiogenic shock
4. Acute coronary syndrome within 30 days prior to randomization
5. Planned or recent percutaneous or surgical coronary intervention within 30 days prior to
randomization
6. Signs of keto-acidosis and/or hyperosmolar hyperglaecemic syndrome (pH>7.30 and glucose >15 mmol/L and HCO3>18 mmol/L)
7. Pregnant or nursing (lactating) women
8. Current participation in any interventional study
9. Inability to follow instructions or comply with follow-up procedures
10. Any other medical conditions that may put the patient at risk or influence study results in the investigator*s opinion, or that the investigator deems unsuitable for the study.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | 2017-001679-22 |
| EudraCT | EUCTR2017-001679-22-NL |
| CCMO | NL62419.042.17 |