A Randomized, Double-blind, Multicenter, Parallel, Placebo-controlled Study l to Evaluate the Efficacy and Safety of Short-term Administration of SIMDAX in Patients With Acutely Decompensated Heart Failure : Korea Bridging Study
Overview
- Phase
- Phase 3
- Sponsor
- Yooyoung Pharmaceutical Co., Ltd.
- Enrollment
- 112
- Locations
- 1
- Primary Endpoint
- Assessment of the Clinical Composite Classification(CCC)
Overview
Brief Summary
A randomized, double-blind, Multicenter, parallel, placebo-controlled study
Detailed 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •5.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.
Arms & Interventions
SIMDAX
Levosimendan2.5mg/mL
Intervention: Simdax (Drug)
SIMDAX Placebo
Water for injection
Intervention: Simdax (Drug)
Outcomes
Primary Outcomes
Assessment of the Clinical Composite Classification(CCC)
Time Frame: 5day
Assessment of the Clinical Composite Classification(CCC) using the Patients Global Assessment(PGA) at 5day after start of IV levosiemendan or Placebo infusion with WHF through 5dyas: Improved, Unchanged, Worse
Secondary Outcomes
- BNP(baseline to 24hr, 48hr, 72hr, and 5day)
- ST2(baseline to 24hr, 48hr, 72hr, and 5day)
- NYHA(baseline to 5day)
- hospitalization(31day)
- Patients Assessment(6hr)
- re-hospitalization(30days)
- death.(30days)
- mortality(30days)
- cardio-renal biomarkers(baseline to 24hr, 48hr, 72hr, and 5day)
- Patient's Global Assessment(6hr)