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Cardiorenal SyndromePhase 3ELDORNCT02133105

Levosimendan Versus Dobutamine for Renal Function in Heart Failure

A Phase 3 study testing Levosimendan and Dobutamine in people with Cardiorenal Syndrome, run by Göteborg University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiorenal Syndrome
What is being tested?
Levosimendan and Dobutamine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteSweden
Study dates
Apr 2014to May 2017
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written, signed and dated informed consent
  • Male and Female subjects ≥18 years of age
  • Chronic congestive heart failure scheduled for right sided cardiac catheterization
  • Left ventricular ejection fraction ≤ 40% determined by echocardiography
  • Elevation of N Terminal-proBNP ≥ 500 ng/L
  • Cardiorenal syndrome (30ml/min ≤ estimated GFR ≤ 80 ml/min (MDRD)

Who cannot join

  • Acute heart failure, untreated
  • Systolic blood pressure < 80 mmHg
  • Tachycardia above 100 bpm
  • Angina Canadian Cardiovascular Society (CCS) class III or higher
  • Aortic stenosis
  • Hypertrophic cardiomyopathy
Show all 11Show fewer
  • Restrictive cardiomyopathy
  • The presence of kidney disease diagnosed before heart failure
  • Administration of radiographic contrast < 1 week
  • Radiographic contrast allergy
  • In the Investigator's opinion, the patient has a clinically significant disease that could be adversely affected by study participation

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Sahlgrenska University Hospital

    Gothenburg, 41345

Other trials in Sweden

About this study

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

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.

Being tested
Levosimendan, Dobutamine
Keywords
Heart failure, Renal failure, Inotropic drugs, Levosimendan, Dobutamine
Medical subject headings
Cardio-Renal Syndrome, Heart Failure, Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LevosimendanDrug

    Also called Simdax

  • DobutamineDrug

    Also called Dobutrex

Study groups in NCT02133105
Study groupRoleWhat they receive
LevosimendanActive comparatorLevosimendan administration is initiated with a loading dose of 12μg/kg given over 10 min followed by a continuous infusion of 0.1 μg/kg/min for 65 min.
Receives: Drug: Levosimendan
DobutamineActive comparatorDobutamine is given as a continuous infusion without a bolus dose. The infusion rate is started at 5.0 μg/kg/min for 10 minutes, and thereafter increased to 7,5 μg/kg/min for 65 min.
Receives: Drug: Dobutamine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in renal blood flow

    Para-aminohippuric acid (PAH) infusion clearance

    Measured: 75 min minus baseline

  2. Change in glomerular filtration rate

    Chrome-ethylenediaminetetraacetic acid (EDTA) infusion clearance

    Measured: 75 min minus baseline

Secondary outcomes (4)

  1. Change in renal vascular resistance

    Renal blood flow divided by the difference between renal arterial pressure and renal venous pressure

    Measured: 75 min minus baseline

  2. Change in central hemodynamics

    Right atrial pressure, mean pulmonary arterial pressure, pulmonary capillary wedge pressure, mean arterial pressure, cardiac output, pulmonary vascular resistance and systemic vascular resistance measured with a pulmonary artery thermodilution catheter.

    Measured: 75 min minus baseline

  3. Change in renal oxygen consumption and oxygen extraction

    Oxygen consumption: Renal blood flow multiplied by arterial-renal venous oxygen difference.

    Oxygen extraction: Ratio of renal oxygen consumption to renal oxygen delivery

    Measured: 75 min minus baseline

  4. Change in filtration fraction

    Ratio of glomerular filtration rate to renal plasma flow

    Measured: 75 min minus baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionMay 2017
  4. Study completionMay 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02133105
Sponsor's protocol ID
2013-000986-36
Other IDs
2013-000986-36
Acronym
ELDOR
Status last verified
Feb 2020
First submitted
5 May 2014
Last updated
25 Feb 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes

Publications

  • Savarese G, Lund LH. Global Public Health Burden of Heart Failure. Card Fail Rev. 2017 Apr;3(1):7-11. doi: 10.15420/cfr.2016:25:2.

    PubMed 28785469

  • Hillege HL, Nitsch D, Pfeffer MA, Swedberg K, McMurray JJ, Yusuf S, Granger CB, Michelson EL, Ostergren J, Cornel JH, de Zeeuw D, Pocock S, van Veldhuisen DJ; Candesartan in Heart Failure: Assessment of Reduction in Mortality and Morbidity (CHARM) Investigators. Renal function as a predictor of outcome in a broad spectrum of patients with heart failure. Circulation. 2006 Feb 7;113(5):671-8. doi: 10.1161/CIRCULATIONAHA.105.580506.

    PubMed 16461840

  • Smith GL, Shlipak MG, Havranek EP, Masoudi FA, McClellan WM, Foody JM, Rathore SS, Krumholz HM. Race and renal impairment in heart failure: mortality in blacks versus whites. Circulation. 2005 Mar 15;111(10):1270-7. doi: 10.1161/01.CIR.0000158131.78881.D5.

    PubMed 15769768

  • Hillege HL, Girbes AR, de Kam PJ, Boomsma F, de Zeeuw D, Charlesworth A, Hampton JR, van Veldhuisen DJ. Renal function, neurohormonal activation, and survival in patients with chronic heart failure. Circulation. 2000 Jul 11;102(2):203-10. doi: 10.1161/01.cir.102.2.203.

    PubMed 10889132

  • Lannemyr L, Ricksten SE, Rundqvist B, Andersson B, Bartfay SE, Ljungman C, Dahlberg P, Bergh N, Hjalmarsson C, Gilljam T, Bollano E, Karason K. Differential Effects of Levosimendan and Dobutamine on Glomerular Filtration Rate in Patients With Heart Failure and Renal Impairment:A Randomized Double-Blind Controlled Trial. J Am Heart Assoc. 2018 Aug 21;7(16):e008455. doi: 10.1161/JAHA.117.008455.

    PubMed 30369310

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Levosimendan and Dobutamine in people with Cardiorenal Syndrome, run by Göteborg University at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in renal blood flow (time frame: 75 min minus baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02133105, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2020.

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