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

Sponsor
University of Erlangen-Nürnberg Medical School
Study ID
NCT03128528
Phase
PHASE2
Status
Completed

Conditions

  • Chronic Heart Failure

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin 10mg — DRUG
    Each patient, after the run-in/wash-out phase, will be randomly assigned in a doubleblind fashion to one of the two treatment sequences according to a randomisation list. and provided by the sponsor.
  • Placebo Oral Tablet — DRUG
    Each patient, after the run-in/wash-out phase, will be randomly assigned in a doubleblind fashion to one of the two treatment sequences according to a randomisation list. and provided by the sponsor.

Study Details

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.

Key Dates

Start date
Jul 1, 2017
Status verified
Sep 2020
Primary completion
Jan 31, 2020
Completion
Apr 30, 2020

Study Design

Enrollment
84 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo Oral Tablet
    Patients will be randomized to empagliflozin 10 mg orally once daily or one placebo tablet orally once daily.
  • Active Comparator: Empagliflozin
    Patients will be randomized to empagliflozin 10 mg orally once daily or one placebo tablet orally once daily.

Primary Outcome Measure

Skin sodium content [ Time Frame: 14 weeks ]

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