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Effectiveness of a Repetitive Use of 24-hour Levosimendan Infusions in Patients With Severe Systolic Heart Failure in Order to Prevent Rehospitalizations

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ClinicalTrials.gov Identifier: NCT03764722
Recruitment Status : Recruiting
First Posted : December 5, 2018
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
Małgorzata Dobosiewicz, PhD, Collegium Medicum w Bydgoszczy

Brief Summary:

Rehospitalizations due to exacerbation of chronic heart failure are an important problem for patients suffering from heart failure.

Rehospitalzations lead to worse prognosis, have an impact on the quality of life and have a negative financial impact on the health care system.

Currently, studies are being conducted on the efficacy of levosimendan in the prevention of heart failure exacerbations. Patients receive levosimendan at repetitive use and preliminary results suggest a reduction in the incidence of exacerbations of heart failure.

Thanks to the clinical trial planned in the Department of Cardiology of the Biziel Hospital with repeatable use of levosimendan, it is possible to determine the benefits of this method of treatment more accurately.


Condition or disease Intervention/treatment Phase
Systolic Heart Failure Drug: Levosimendan Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of a Repetitive Use of 24-hour Levosimendan Infusions in Patients With Severe Systolic Heart Failure in Order to Prevent Rehospitalizations
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Levosimendan Drug: Levosimendan

The patient will initially receive a standard dose of 0.1 mcg/kgmc/min. In case of good tolerance of the drug - the dose will be increased to 0.2 mcg/kgmc/min. If hypotension SBP <90 mmHg occurs, the dose will be reduced to 0.05 mcg / kgm / min. If the hypotension persists despite the reduction of the drug - the infusion will be terminated and the patient will be excluded from the study. The infusion will be terminated within 24 hours, the patient will be examined again 4 hours after the end of the infusion, by the attending physician and unless there are contraindications - discharged home.

Patients will be hospitalized every 4 weeks for the next 6 months.





Primary Outcome Measures :
  1. Number of rehospitalisations in patients with severe heart failure treated with 24-hour levosimendan infusions [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Change in quality of life in patients with severe heart failure treated with 24-hour levosimendan infusions. [ Time Frame: from baseline up to 4 weeks during 6 months ]
    via SF-36 questionnaire

  2. Change in sodium in patients with severe heart failure treated with 24-hour: SF-36 questionnaire levosimendan infusions. [ Time Frame: from baseline up to 4 weeks during 6 months ]
    counted in mmol/l

  3. Change in kaldyum in patients with severe heart failure treated with 24-hour levosimendan infusions. [ Time Frame: from baseline up to 4 weeks during 6 months ]
    counted in mmol/l

  4. Change in NT-proBNP in patients with severe heart failure treated with 24-hour levosimendan infusions. [ Time Frame: from baseline and up to 4 weeks during 6 months. ]
    counted in ng/l

  5. Change in troponin T in patients with severe heart failure treated with 24-hour levosimendan infusions. [ Time Frame: from baseline and up to 4 weeks during 6 months. ]
    counted in μg/l



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- at least 2 hospitalizations due to exacerbation of chronic heart failure with reduction of left ventricular ejection fraction (EF< 40%) during last 6 months, despite optimal heart failure treatment

Exclusion Criteria:

  • chronic kidney disease (GFR < 30)
  • severe liver damage (AT 5x > N, bilirubin >2,0 g/dl)
  • hypotonia
  • hypokalemia
  • HGB<10g/dl
  • severe aortic and mitral stenosis
  • tachycardia >100/min or atrial fibrillation with HR > 120/min
  • features of hypovolemia
  • levosimendan intolerance
  • acute infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03764722


Contacts
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Contact: Małgorzata Dobosiewicz, PhD 48602288918 margotd@poczta.onet.pl
Contact: Wojciech Hertmanowski, MD 48505518399 woj.hertmanowski@gmail.com

Locations
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Poland
Second Department of Cardiology Recruiting
Bydgoszcz, Poland, 85-168
Sponsors and Collaborators
Collegium Medicum w Bydgoszczy
Investigators
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Principal Investigator: Grzegorz Grześk, Professor Collegium Medicum w Bydgoszczy

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Responsible Party: Małgorzata Dobosiewicz, PhD, Professor Grzegorz Grześk, Collegium Medicum w Bydgoszczy
ClinicalTrials.gov Identifier: NCT03764722     History of Changes
Other Study ID Numbers: KB 431/2018
First Posted: December 5, 2018    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Małgorzata Dobosiewicz, PhD, Collegium Medicum w Bydgoszczy:
Levosimendan
Rehospitalisation
Heart failure

Additional relevant MeSH terms:
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Heart Failure
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases
Simendan
Cardiotonic Agents
Vasodilator Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs