Effects of Empagliflozin on Diuresis and Renal Function in Patients With Acute Decompensated Heart Failure
Status:
Completed
Trial end date:
2021-06-29
Target enrollment:
Participant gender:
Summary
Heart failure is the most common hospital admission diagnosis and shows increasing incidence
and prevalence in Germany, the United States and worldwide. Improvements in the primary
treatment conditions for e.g. myocardial infarction and reduced primary mortality has
resulted in an increasing group of patients with secondary cardiac abnormalities including
chronic heart failure.
Progressive cardiac dysfunction and failure are associated with exercise intolerance, volume
retention, nocturia, dyspnoea among others. The most severe progression of heart failure is
cardiac decompensation (also called: acute heart failure) and cardiogenic shock. Volume
retention, abnormal renal function and diuretic resistance are hallmarks of this clinical
phenotype. Currently, the only available treatment is diuresis through various combinations
of diuretics and the addition of cardiac inotropes when cardiac hypoperfusion is documented.
Patients with acute decompensated heart failure (ADHF) often develop a state of diuretic
resistance characterized by a need of rising dosages of diuretics for adequate diuresis and
urine production.
ADHF patients also show metabolic abnormalities including insulin resistance or type 2
diabetes mellitus.
Empagliflozin is a potent and selective inhibitor of the sodium glucose cotransporter 2
(SGLT2) used in the treatment of type 2 diabetes. By inhibiting SGLT2, empagliflozin reduces
renal glucose reabsorption and increases urinary glucose excretion. In addition to reducing
hyperglycaemia, empagliflozin is associated with osmotic diuresis, reductions in weight and
blood pressure without increases in heart rate, and has favourable effects on markers of
arterial stiffness and vascular resistance.
The investigators propose a single center exploratory study to test the hypothesis that the
application of empagliflozin in addition to standard diuretic regimens increases urine
output, decreases the need for further acceleration of diuretic regimens, and positively
influences renal function as well as metabolism including insulin resistance in ADHF
patients. Thereby, empagliflozin may be effective in the prevention of complex cardio
metabolic alterations involved in ADHF.
Phase:
Phase 2
Details
Lead Sponsor:
Christian Schulze
Collaborators:
Boehringer Ingelheim Zentrum für Klinische Studien Jena