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Acute Decompensated Heart FailurePhase 3NCT03555123

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

A Phase 3 study testing Simdax in people with Acute Decompensated Heart Failure, run by Yooyoung Pharmaceutical Co., Ltd. at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A randomized, double-blind, Multicenter, parallel, placebo-controlled study Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Decompensated Heart Failure
What is being tested?
Simdax
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
112 participants
Where
1 siteSouth Korea
Study dates
11 Jan 2019to 30 Jul 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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.

Who cannot join

  • 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.
Show all 27Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Lee Su-min contact

+82-2-6202-7119

smlee@yypharm.co.kr

South Korea1 site, 1 recruiting

  • Severance Hospital

    Seoul

    Suck-min Kang, MD.PhD.

    Recruiting

Other trials in South Korea

About this study

Official title: 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

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

Read the 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

Being tested
Simdax

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SimdaxDrug

    Levosimendan2.5mg/ml

Study groups in NCT03555123
Study groupRoleWhat they receive
SIMDAXExperimentalLevosimendan2.5mg/mL
Receives: Drug: Simdax
SIMDAX PlaceboPlacebo comparatorWater for injection
Receives: Drug: Simdax

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 5day

Secondary outcomes (10)

  1. BNP

    Change from baseline in plasma BNP levels at 24hr, 48hr, 72hr, and 5day

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

  2. ST2

    Change from baseline in plasma ST2 at 24hr, 48hr, 72hr, 5day

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

  3. NYHA

    New York Heart Association(NYHA) functional classification at 5 days.

    Measured: baseline to 5day

  4. hospitalization

    Length of intensive care unit and /or Coronary care unit stay for the index ADHF hospitalization

    Measured: 31day

  5. cardio-renal biomarkers

    Change from baseline in cardio-renal biomarkers (Creatinine, BUN, NGAL) at 24hr, 48hr, 72hr and 5day

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

  6. Patient's Global Assessment

    Patient's Global Assessment (PGA, 7-likert scale) at 6 hr.

    : Check rate of patients who responded with Moderate or Marked improvement

    Measured: 6hr

  7. Patients Assessment

    Patients Assessment of dyspnea(7-likert scale) at 6hr

    : Check rate of patients who responded with Moderate or Marked improvement

    Measured: 6hr

  8. re-hospitalization

    Time to re-hospitalization due to heart failure after discharge

    Measured: 30days

  9. death.

    Time to CV death.

    Measured: 30days

  10. mortality

    All cause mortality through 30days

    Measured: 30days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2018
  2. Study start11 Jan 2019
  3. Primary completion30 Jan 2022 (estimated)
  4. Study completion30 Jul 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
112 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03555123
Sponsor's protocol ID
YY_YYBRS001
Status last verified
May 2021
First submitted
24 May 2018
Last updated
11 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Simdax in people with Acute Decompensated Heart Failure, run by Yooyoung Pharmaceutical Co., Ltd. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lee Su-min (+82-2-6202-7119, smlee@yypharm.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of the Clinical Composite Classification(CCC) (time frame: 5day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03555123.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2021.

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