End-stage heart failure
Conditions
Interventions
Treatment group:Intermittent infusion of intravenous levosimendan (0.2 µg/kg/min, without loading dose) over 6 hours once every 2 weeks
Standard care group:Standard care with follow-up every 2 weeks
Sponsors
N.A. (PI initiated study; PI: Dr Erik Fung)
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients meeting all of the following criteria will be eligible for study entry: 1) Aged >= 65 years; 2) NYHA III or IV; 3) CRT non-responder; 4) Left ventricular ejection fraction (LVEF) =6 months; 6) Not heart transplant candidate; 7) Not ventricular assist device candidate; 8) Able to give informed consent with good mental capacity and competence.
Exclusion criteria
Exclusion criteria: Patients meeting at least one of the following criteria will be excluded from the study: 1) Active malignancy at the time of study eligibility assessment; 2) Debilitating stroke before the start of the study; 3) Withdrawal by self or family from study; 4) Estimated GFR (calculated by CKD-EPI) < 30 mL/min/1.73m2 at study entry; 5) Complete heart block at study entry; 6) Malignant arrhythmias at study entry; 7) Acute coronary syndrome within 3 months prior to eligibility assessment; 8) Systolic BP < 90 mmHg at study entry; 9) Unoperated hypertrophic obstructive cardiomyopathy or severe aortic stenosis; 10) Hypokalaemia; 11) Severe renal or hepatic impairment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NT-proBNP levels or GDF-15-directed metabolomic shift; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cardiac and frailty biomarkers;Peak oxygen consumption (VO2);6-minute walking distance; | — |
Countries
China
Contacts
Public ContactDr Erik Fung
Department of Medicine & Therapeutics, The Chinese University of Hong Kong
Outcome results
None listed