A prospective, multi-center, randomized, controlled study of levosimendan in the treatment of acute ischemic heart failure

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200059855

Enrollment

Unknown

Registered

2022-05-13

Start date

2022-05-01

Completion date

Unknown

Last updated

2024-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure

Interventions

Intervention group:Levosimendan

Control group:Dobutamine

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Inclusion criteria

Inclusion criteria: (1) Participate voluntarily and sign the informed consent form. (2) Age 18 to 90 years old, male or female. (3) Hospitalization for acute heart failure, defined as including all of the following from the time of presentation (including emergency and outpatient) to the end of screening with any test results meeting all of the following criteria: ? Symptoms and/or signs of heart failure present at screening and randomization; ? BNP =350 pg/mL or NT-proBNP =1400 pg/mL. (4) Have a clear history of ischemic heart disease, including history of myocardial infarction, history of percutaneous coronary intervention (PCI), history of cardiac bypass (CABG), coronary angiography or coronary CT showed coronary stenosis = 70% of patients. (5) Left ventricular ejection fraction (LVEF) <50% within the first half year of randomization.

Exclusion criteria

Exclusion criteria: 1. Patients who are allergic to levosimendan or any other excipients; 2. Patients with non-ischemic heart failure; 3. Systolic blood pressure =130 beats/min before randomization; 5. Uncorrectable serum potassium 5.5mmol/L; 6. Mechanical obstructive diseases that significantly affect ventricular filling or/and ejection function; 7. Patients with severe liver and kidney (creatinine clearance 38.5 degree (oral body temperature or equivalent), sepsis, and active infection requiring IV antibiotic treatment; 9. Patients with a history of torsades de pointes (TdP).

Design outcomes

Primary

Measure	Time frame
Natriuretic peptide;	—

Secondary

Measure	Time frame
Troponin;NYHA Classification;eGFR;Types and doses of drug therapy;Heart failure readmission;Cardiovascular death;All-cause death;	—

Countries

China

Contacts

Public ContactXiaotong Cui

Zhongshan Hospital, Fudan University

cui.xiaotong@zs-hospital.sh.cn+86 13681959319

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026