Analysing the Effect of Empagliflozin on Reduction of Tissue Sodium Content in Patients With Chronic Heart Failure

• Status: Completed
• Trial end date: 2020-04-30
• Target enrollment: 0
• Participant gender: All

Summary

The hypothesis is that the SGLT-2 inhibitor empagliflozin reduces tissue sodium content in patients with chronic heart failure, and if the hypothesis is proven, that this mechanism contributes to the beneficial effects found in EMPA-REG Outcome trial potentially via exerting beneficial effects on the vascular structure and function of the micro- and macrocirculation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Erlangen-Nürnberg Medical School
• Treatments: Empagliflozin

Criteria

Inclusion Criteria:

• Age of 18 - 85 years

• Male and Female patients (females of child bearing potential must be using adequate contraceptive precautions)

• CHF (symptoms and/or sign of CHF, ejection fraction < 40% (HfrEF) 14 or symptoms and/or signs of CHF, ejection fraction 40-49 % and NT-pro BNP > 125 pg/ml, and at least one structural abnormality of left atrium or ventricle (HFmEF) 14 in stable conditions.

• Females of childbearing potential or within two years of the menopause must have a negative urine pregnancy test at screening visit.

• Informed consent has to be given in written form.

Exclusion Criteria:

• Any other form of diabetes mellitus than type 2 diabetes mellitus

• Use of insulin or any SGLT-2 inhibitor within the past 10 weeks prior to the screening visit (visit 1).

• Patients with more than two blood glucose lowering medications

• Uncontrolled diabetes (fasting plasma glucose ≥ 240 mg/dl, HbA1c ≥ 10%)

• Any history of stroke, transient ischemic attack, instable angina pectoris, or myocardial infarction within the last 6 months prior to study inclusion

• Estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m² (following the inclusion criteria of EMPA-REG OUTCOME study 1-3)

• Chronic heart failure NYHA stage IV

• Use of loop diuretics above furosemide > 80 mg/day, or torasemide >40 mg/day, or piretanide > 6 mg/day

• Implanted pacemakers or defibrillators

• Any other relevant clinical contraindication of MRI examination

• Uncontrolled arterial hypertension (i.e. ≥ 180/110 mmHg)

• Severe disorders of the gastrointestinal tract or other diseases which interfere with the pharmacodynamics and pharmacokinetics of study drugs

• Significant laboratory abnormalities such as Serum Glutamate-Oxaloacetate-Transaminase (SGOT) or Serum Glutamate-Pyruvate-Transaminase (SGPT) levels more than 3 x above the upper limit of normal range