acute decompensated heart failure
Conditions
Interventions
control group:placebo
Sponsors
Shanghai Tenth People's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients >18 years of age with the capacity to provide written informed consent; 2. LVEF = 300 pg/mL or N-terminal (NT)-proBNP >= 1200 pg/mL; 4. Sinus rhythm and heart rate >= 90 bpm# at the start and at the end of screening; 5. Able to be randomized within 16 hours from presentation to the hospital; 6. New York Heart Association functional classes III-IV; 7. SBP >= 100mmHg.
Exclusion criteria
Exclusion criteria: 1. Currently taking ivabradine or any use within the past 30 day; 2. Enrollment in any other clinical trial involving an investigational agent or device; 3. History of hypersensitivity, known or suspected contraindications, or intolerance to any of the study drugs including heart rate slowing drugs such as beta-blockers; 4. History of atrial fibrillation, pacemaker implant, long QT syndrome; 5. Symptomatic bradycardia or second- or third-degree heart block; 6. ACS, active myocarditis, stroke, TIA, coronary or carotid revascularization, or major CV surgery within the past 3 month; 7. Primary cause of dyspnea due to non-cardiac, non-HF causes such as acute or chronic respiratory disorders; 8. Planned coronary or carotid revascularization within the next 6 m; 9. Implantation of cardiac resynchronization therapy within the past 3 m or intent to place; 10. Patients with a history of heart transplant, currently on the transplant list, or with an left ventricular device; 11. Isolated right HF due to severe pulmonary disease; 12. Documented untreated ventricular arrhythmia with syncopal episodes within the past 3 month; 13. Presence of hemodynamically significant mitral, aortic, or hypertrophic obstructive cardiomyopathy; 14. History of malignancy or any organ system (other than localized and resectable skin cancers) within the past year with a life expectancy of less than 1 year; 15. Known hepatic impairment (as evidenced by total bilirubin >3 mg/dL or increased ammonia levels) or history of cirrhosis with evidence of portal hypertension (eg, presence of esophageal varices); 16. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin test result; 17. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant unless they are using 2 birth control methods.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| all-cause mortality;readmission caused by heart failure; | — |
Secondary
| Measure | Time frame |
|---|---|
| cardiac remodeling;cardiac functional capacity;quality of life; | — |
Countries
China
Contacts
Public ContactDachun Xu
Shanghai Tenth People's Hospital
Outcome results
None listed