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Clinical Trials/EUCTR2018-003692-35-DE
EUCTR2018-003692-35-DE
Active, Not Recruiting
Phase 1

Effects of empagliflozin on diuresis and renal function in patients with acute decompensated heart failure - EMPAG-HF

Friedrich Schiller University Jena0 sites60 target enrollmentFebruary 14, 2019
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Conditionsacute decompensated heart failureMedDRA version: 20.0Level: LLTClassification code 10000803Term: Acute heart failureSystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
DrugsJardiance

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
acute decompensated heart failure
Sponsor
Friedrich Schiller University Jena
Enrollment
60
Status
Active, Not Recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 14, 2019
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Friedrich Schiller University Jena

Eligibility Criteria

Inclusion Criteria

  • •Patients (between 18 \- 85 years) with acute decompensated heart failure (HF).
  • •Brain Natriuretic Peptide (BNP) \>100 pg/ml, or N\-terminal pro\-BNP (NT\-proBNP)\>300 pg/ml as defined by current clinical guidelines for the diagnosis of acute decompensated HF (European Society of Cardiology 2016 HF guideline)
  • •Patients with diabetes mellitus type 2 or impaired glucose tolerance as defined by current clinical guidelines (German and International Diabetes Society 2016: HbA1c\>6\.5 % (upper limit for this clinical Trial 12%) or fasting glucose \>7\.0 mmol/l or any incidental glucose level \>11\.1 mmol/l or abnormal oral glucose tolerance test with 2h plasma glucose \>7\.8 mmol/l) or on antidiabetic medication or antidiabetic diet or patients with normal glucose tolerance
  • •Patients without cognitive impairment, i.e. they must be capable of understanding the nature, significance and implications of the clinical trial and to form a rational intention in the light of the Facts
  • •Written informed consent obtained
  • •For women with childbearing potential (until 2 years after menopause):
  • •o Negative pregnancy test
  • •o regular and correct use of a highly effective contraceptive method with an error rate of \<1% per year (e.g. combined (estrogen and progesteron) hormonal contraception, (oral, intravaginal, transdermal), progesteron\-only hormonal contraception, (oral, injectable, implantable), intrauterine device (IUD), intrauterine hormone\-releasing system ( IUS)) tubal ligation (female sterilization), hormon donating intrauterine device (hormonal spiral), double barrier methods, sexual abstinence, vasectomy of the partner)
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:

Exclusion Criteria

  • •Type 1 diabetes mellitus
  • •Chronic Kidney Disease (CKD) with eGFR\< 30 ml/min (if obviously not related to acute kidney injury), or end\-stage renal failure with the need for chronic dialysis treatment
  • •Acute kidney injury (AKI) \=AKIN stage 2 or requiring dialysis treatment
  • •Current medication with SGLT\-2 inhibitors
  • •Known intolerance or hypersensitivity to the active substance empagliflozin, lactose or any other of the excipients listed in section 6\.1\. of the SmPC
  • •A contraindication or intolerance to furosemide
  • •Acute heart failure without signs of congestion (dry” patient)
  • •Indication for urgent coronary angiography or planned administration of a iodine based contrast agent within the next 6 days.
  • •Need for hemofiltration or any other form of extracorporeal therapy
  • •Planned surgery

Outcomes

Primary Outcomes

Not specified

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