Dilated cardiomyopathy
Conditions
Interventions
Placebo control group:Standard medical therapy for heart failure with intermittent repeated intravenous placebo (saline injection)
Intermittent repeated trial medication group:Standard medical therapy for heart failure with intermittent repeated intravenous levosimendan administration at an interval of 1 week
Sponsors
Fuwai Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients hospitalized for severe DCM heart failure must meet all of the following conditions to be eligible for inclusion in this study: 1.Participate in the study voluntarily, understand and sign the informed consent; 2.Aged 18 to 75 years, male or female; 3.With body weight of 40 to 90 kg; 4.It meets the clinical diagnostic criteria for DCM in The Chinese Guideline for diagnosis and Treatment of Dilated Cardiomyopathy 2018, and meets the following conditions: (1)With symptom duration of HF > 6 months and admitted to hospital or emergency department (ED) at least 2 times over the past 12 months, or at least 1 time over the past 6 months; (2)With persistent NYHA functional class III or IV within one month before randomization; (3)With left ventricular end-diastolic diameter (LVEDD) > 60 mm and left ventricular ejection fraction (LVEF) 3000 pg/mL was measured within 1 day before randomization, except for other diseases that caused elevation; (5)With systolic blood pressure (SBP) at rest of > 85 mmHg (1 mmHg = 0.133 kPa). 5.Receiving guideline directed medical therapy (GDMT) based on the Chinese Guideline for the Diagnosis and Treatment of Heart Failure 2018 at least 4 weeks before randomization unless contraindication or intolerance, including an angiotensin coverting enzyme inhibitor (ACEI) or angiotensin receptor blocker,ARB) or angiotensin receptor neprilysin inhibitor (ARNI), beta-blocker, aldosterone receptor antagonist (spironolactone) and loop diuretics.
Exclusion criteria
Exclusion criteria: 1.Pregnant women, women on breastfeeding, women of reproductive age without adequate contraceptive; 2.With cardiogenic shock or symptomatic hypotensin (such as dizziness, presyncope, fatigue, etc) or resting SBP =180 mmHg and/or diastolic blood pressure >=110 mmHg were taken at least 10 min intervals prior to randomrandomism and were not corrected by medication; 4.At least 10 minutes before randomization, resting heart rate was measured twice >=120 times/min; 5.With symptomatic bradycardia (i.e. resting HR 221 µmol/L or estimated glomerular filtration rate (eGFR) 5.5 mmol/L which can not be corrected; 9.With moderate or severe anemia (i.e., globulin level <= 90g/L); 10.With peripheral artery disease or lower limb diseases which influencing 6-minute walking test (6MWT); 11.With history of torsade de pointes of ventricular tachycardia; 12.With unexplained or uncorrected syncope within 3 months before randomization; 13.With planned heart transplantation or left ventricular assist device implantation or other major surgery within subsequent 3 months; 14.With other serious diseases leading to poor prognosis or reduced survival rate, such as acute infection, sepsis, malignancy, or serious diseases of other vital organs, or other serious uncontrolled diseases of various systems, or life expectancy of less than half a year; 15.Participated in clinical trials of other drugs within 1 month before randomization; 16.Use of levosimendan within 2 weeks or other positive inotrophic agents within 24 hours before randomization; 17.With known allergy to the experimental drug or any other excipient; 18.Any other medical conditions which may affect the subjects ability to comply with the treatment regimen or unsuitable for the study, including drug or alcohol abuse or mental illness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of major adverse cardiac events resulting from cardiovascular death or worsening heart failure; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time of first major adverse cardiac event;The incidence of major adverse cardiac events or the time of the first major adverse cardiac event;Plasma NT-probNP levels (pg/mL) or a reduction of >= 30% from baseline (%);Dyspnea score or 6MWD (m), or >=20% improvement from baseline (%);The heart failure quality of life score;Echocardiographic index;Renal function index;Total medical costs associated with heart failure; | — |
Countries
China
Contacts
Public ContactZou Changhong
Heart Failure Care Unit (HFCU), Heart Failure Center, Fuwai Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed