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

NCT03555123 | Unknown Phase 3

• 1 other identifier: YY_YYBRS001
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Decompensated Heart Failure

Outcome Measures

Primary Outcomes (1)

• Assessment of the Clinical Composite Classification(CCC)

  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

  5day

Secondary Outcomes (10)

• BNP

  baseline to 24hr, 48hr, 72hr, and 5day

• ST2

  baseline to 24hr, 48hr, 72hr, and 5day

• NYHA

  baseline to 5day

• hospitalization

  31day

• cardio-renal biomarkers

  baseline to 24hr, 48hr, 72hr, and 5day

Study Arms (2)

SIMDAX

EXPERIMENTAL

Levosimendan2.5mg/mL

Drug: Simdax

SIMDAX Placebo

PLACEBO COMPARATOR

Water for injection

Drug: Simdax

Interventions

Simdax DRUG

Levosimendan2.5mg/ml

SIMDAX; SIMDAX Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yooyoung Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Severance Hospital

Seoul, South Korea

RECRUITING

Study Officials

• Suck-min Kang, MD.PhD.

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lee Su-min

CONTACT

+82-2-6202-7119; smlee@yypharm.co.kr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2018
• First Posted: June 13, 2018
• Study Start: January 11, 2019
• Primary Completion: January 30, 2022
• Study Completion: July 30, 2022
• Last Updated: May 11, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)