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NCT02133105: ELDOR

Efficacy of Intravenous Levosimendan Compared With Dobutamine on Renal Hemodynamics and Function in Chronic Heart Failure

Completed Phase 3 Last updated 24 February 2020
What this trial tests

Phase 3 trial testing Levosimendan in Cardiorenal Syndrome in 33 participants. Completed in 1 May 2017.

Timeline
1 April 2014
Primary endpoint
1 May 2017
1 May 2017

Quick facts

Lead sponsorGöteborg University
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment33
Start date1 April 2014
Primary completion1 May 2017
Estimated completion1 May 2017
Sites1 location across Sweden

Drugs / interventions tested

Conditions studied

Sponsor

Göteborg University

Who can join

18 and older, any sex, with Cardiorenal Syndrome. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

Although inotropes have a favorable effect on central hemodynamics in patients with heart failure, their effect on renal hemodynamics is incompletely defined. The purpose of this study is to evaluate the efficacy of a 75 min intravenous infusion of levosimendan compared to a 75 min infusion of dobutamine on renal hemodynamics and function in patients with chronic heart failure and signs of cardiorenal syndrome. The investigators hypothesis is that patients treated with levosimendan will show greater increases in renal blood flow and glomerular filtration rate (GFR) than those treated with dobutamine.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Differential Effects of Levosimendan and Dobutamine on Glomerular Filtration Rate in Patients With Heart Failure and Renal Impairment:A Randomized Double-Blind Controlled Trial.
    Lannemyr L, Ricksten SE, Rundqvist B, Andersson B, et al · · 2018 · cited 46× · PMID 30369310 · DOI 10.1161/jaha.117.008455
  2. Acute kidney injury: emerging pharmacotherapies in current clinical trials.
    Benoit SW, Devarajan P. · · 2018 · cited 33× · PMID 28601936 · DOI 10.1007/s00467-017-3695-3
  3. Differential effects of inotropes and inodilators on renal function in acute cardiac care.
    Zima E, Farmakis D, Pollesello P, Parissis JT. · · 2020 · cited 12× · PMID 32431569 · DOI 10.1093/eurheartj/suaa091
  4. Cardiorenal Syndrome Type 1: Renal Dysfunction in Acute Decompensated Heart Failure.
    Prins KW, Thenappan T, Markowitz JS, Pritzker MR. · · 2015 · cited 8× · PMID 27158218

Verify or expand the search:

Other trials of Levosimendan

Trials testing the same drug.

Other recruiting trials for Cardiorenal Syndrome

Currently open trials in the same condition.

Other Göteborg University trials

Trials by the same sponsor.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing