Evaluate the Efficacy and Safety of Short-term Administration of SIMDAX

  • STATUS
    Recruiting
  • End date
    Jul 30, 2022
  • participants needed
    112
  • sponsor
    Yooyoung Pharmaceutical Co., Ltd.
Updated on 16 May 2021

Summary

A randomized, double-blind, Multicenter, parallel, placebo-controlled study

Description

The purpose of the study is to evaluate the efficacy, safety and tolerability of intravenous infusion of Levosimendan for 24hrs in patients with ADHF who will be hospitalized with ADHF and continue to have symptom of dyspnea at rest(NYHA Class III or IV) despite with treatment of SOCs(include intravenous diuretics, vasodilators and/or positive inotropic drugs but except amrinone and milrinone) within 48hrs

Efficacy is measured by Clinical composite classification(Improved, No change, Worse), bio-marker(change of BNP and ST-2), Patient's Global Assessment, NYHA functional Classification, hospitalization period and renal function tests(change of creatinine, BUN and NGAL) Safety is measured by recording the incidence of adverse events(AEs), vital signs, clinical blood safety tests(biochemistry, hematology) and concomitant medications

Details
Condition Acute Decompensated Heart Failure
Treatment Simdax
Clinical Study IdentifierNCT03555123
SponsorYooyoung Pharmaceutical Co., Ltd.
Last Modified on16 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Written, signed and dated informed consent by the patient or the patient's legally authorized representative
Male and female patients over 18 years of age
Patients with chronic heart failure who were diagnosed with acute decompensated heart failure
Hospitalization for with a primary or secondary diagnosis at admission of worsening heart failure within the 48 hours prior to start of study drug infusion. Symptoms of worsening heart failure must have been treated with IV diuretics Patients who have been hospitalized more than 48 hours may be enrolled if they fail to improve clinically to treatments administered during the first 48 hours (1)(following initial improvement) their clinical status deteriorates either spontaneously or following the withdrawal of intravenous medications
(2) Infusion rates for continuous IV diuretics, inotropes and vasodilators
must have been unchanged for at least 2 hours prior to baseline
Left ventricular ejection fraction less than or equal to 35% as assessed
using echocardiography, radionuclide ventriculography or contrast angiography
within the previous 12 months 6.Dyspnea at rest at both screening and
baseline, as assessed by the patient

Exclusion Criteria

Severe obstruction of ventricular outflow tracts such as hemodynamically significant uncorrected primary valve disease and restrictive or hypertrophic cardiomyopathy
Patients scheduled to receive angioplasty, cardiac surgery, a LV assist device or a heart transplant within 3months after randomization
Patients who have undergone cardioversion during the 4 hours prior to baseline or are expected to undergo cardioversion in the 5 days after baseline
Patients who have undergone a cardiac resynchronization procedure within the 30 days of screening or are expected to undergo such a procedure within 3 months
Patients who have received an IV diuretics dose (including or change in dose of a continuous diuretic infusion) within 2 hours of the baseline assessments
Patients who are intubated or otherwise not able to comply with the pre-study assessments
Stroke or TIA within 3 months prior to randomization
Systolic blood pressure 90 mmHg or less at screening or baseline
Heart rate 120 bpm or greater, persistent for at least 5 minutes at screening or baseline
Serum potassium less than 3.5mmol/l or greater than 5.4 mmol/l
Angina pectoris during the 6 hours before baseline
Administration of amrinone or milrinone within 24 hours before start of study drug infusion
Hypersensitivity to levosimendan or any of the excipients: Povidone, Citric acid, Ethanol
A history of Torsades de Pointes
Severe renal insufficiency (serum creatinine > 450mol/l (5.0 mg/dl)) or on dialysis
Significant hepatic impairment or elevation of liver enzymes to 5 times the upper limit of normal
Acute bleeding or severe anemia (hemoglobin < 10g/dl or blood transfusion during current admission) or acute decompensation due to an active infection
Patients with low hemoglobin between 9-10g/dl may be
Enrolled provided there is no evidence of bleeding, no intention to transfuse blood, no identified cause for anemia other than renal insufficiency and if the severity of anemia is longstanding (documented hemoglobin +/-1 g/dl of screening value > 30 days prior)
History of severe chronic obstructive pulmonary disease or unstable bronchial asthma as evidenced by e.g. CO2 retention or ongoing use of oral, intravenous or intramuscular steroids
Patients with pneumonia or pneumothorax
Patients with non-cardiac respiratory distress
A person with a BNP level of less than 100pg/mL on screening for an organ laboratory test
Active infected patients who need to have symptoms of fever over 38.5 or get an intravenous administration of septicemia or antimicrobial agents
Pregnant and lactating women
Patients who take Investigational Product including other clinical study within screening 4 weeks
In case of unsuitable patients who are participated in this study because of other reason
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