MedTrace Logo

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

NCT03764722 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2018-12-05

No results posted yet for this study

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.

Conditions

  • Systolic Heart Failure

Interventions

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.

Sponsors & Collaborators

  • Collegium Medicum w Bydgoszczy

    lead OTHER

Principal Investigators

  • Grzegorz Grześk, Professor · Collegium Medicum w Bydgoszczy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • Poland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03764722 on ClinicalTrials.gov