heart failure
Conditions
Interventions
experiment group:Levosimendan
control group:placebo
Sponsors
Fuwai Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be selected, all the following conditions must be met: 1) Voluntary participation, understanding and signing of informed consent; 2) Aged >= 18 years and 1000pg/ml or atrial fibrillation when nt-probnp >1200pg/ml, except Other diseases that cause its elevation; C) within 1 month before the random continuous NYHA III level or ambulatory NYHA ? level (rest or mild physical activity had difficulty breathing and/or fatigue symptoms); D) A history of heart failure of at least 3 months, with satisfaction of having been hospitalized or visited the emergency room for heart failure at least 2 times in the past 12 months or at least 1 time in the past 6 months; 4) Patients who have previously received the recommended medication for 4 weeks in accordance with the Chinese Guidelines for the treatment of Heart failure (2014) (confirmed to meet the following requirements) should receive -blockers, angiotensin converting enzyme inhibitors (AC-I)/angiotensin receptor blockers if there is no contraindications or intolerance (ARB), aldosterone receptor antagonist. Optimal treatment was achieved in accordance with the guidelines during the study period, and for patients who did not use and titrate such drugs in accordance with the guidelines, reasons should be documented.
Exclusion criteria
Exclusion criteria: If any of the following conditions exist, it cannot be included: 1) The resting systolic blood pressure >= 180mmHg and/or diastolic blood pressure >= 110mmHg during the two independent examinations before randomization, and the drug cannot be corrected; Heart rate >= 130 beats/min before random; 2) Hepatic transaminase and bilirubin caused by non-heart failure were 3 times higher than the upper limit of normal value, and the glomerular filtration rate was less than 30ml/min/1.73m2 (MDRD formula); 3) Patients with hemoglobin concentration 5.5mmol/L; 5) Valvular heart disease, congenital heart disease, aortic dissection and aortic aneurysm requiring surgical or interventional treatment; 6) Acute decompensated heart failure, cardiogenic shock, or systolic blood pressure <85mmHg with current hemodynamic instability. 7) Hypertrophic obstructive cardiomyopathy, restricted cardiomyopathy, and other secondary and invasive cardiomyopathy; Active myocarditis; 8) Constrictive pericarditis and other pericardial diseases; Infective endocarditis, endocarditis, neoplasms or active thrombus; 9) A history of syncope that cannot be explained or corrected within 3 months; 10) Symptomatic bradycardia or grade II or III heart block, no pacemaker installed; 11) Malignant ventricular arrhythmias that affect hemodynamics; A history of torsional ventricular tachycardia; 12) The intention to implant pacemaker/defibrillator (CRT-P/D) within 6 months after randomization was estimated; 13) Occurrence within 3 months: acute coronary syndrome, stroke, transient ischemic attack; Cardiac, carotid, or other major vascular surgery; Percutaneous coronary intervention (PCI) or carotid angioplasty or coronary artery bypass grafting (CABG) and other cardiac procedures; Or expected to undergo percutaneous cardiac intervention and surgical cardiac surgery in the next 6 months; 14) Had undergone major surgery within the first 3 months at random; Or is expected to undergo major surgical treatment within 6 months; 15) Plan to undergo a heart transplant or implant a left ventricular assist device within the next 6 months; 16) Acute deep venous thrombosis of the lower extremity or acute pulmonary embolism; 17) No 6-minute walking test; Peripheral artery disease, lower limb disease, neurological disease, chronic obstructive pulmonary disease, pulmonary vascular disease such as primary pulmonary hypertension, pulmonary hypertension caused by autoimmune disease, etc., which interfered with the 6-minute walk test. 18) A history of major organ transplantation (such as lung, liver, heart, bone marrow, kidney); 19) The existence of other serious diseases that lead to poor prognosis or reduced survival rate, such as acute infection, sepsis, tumors, and other diseases of vital organs, is expected to shorten life expectancy to less than half a year; Other serious diseases of various systems that are not under control; 20) Before screening, levosimendan was used within 2 weeks or other intravenous positive inotropic drugs were used within 24 hours; 21) Known to be allergic to any test drug or ingredient; 22) Participate in other drug clinical researchers within 1 month; 23) Having a pregnancy (positive on a pregnancy test) or during lactation; Women of childbearing age who do not use adequate contraception; 24) Any other medical condition the investigator believes may place the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intermittent use of levosimendan improved the 6-minute walking distance compared with placebo on the basis of standard heart failure treatment;On the basis of standard heart failure treatment, intermittent administration of Levosimendan reduced the incidence of composite end points of cardiovascular death and total heart failure rehospitalization at 40 weeks, compared with placebo.; | — |
Countries
China
Contacts
Public ContactZhang Jian, Zhang Yuhui
Fuwai Hospital
Outcome results
None listed