Systolic heart failure MedDRA version: 14.1 Level: LLT Classification code 10019279 Term: Heart failure System Organ Class: 100000004849
Conditions
Interventions
Trade Name: The trial drug is from Astellas Pharma, Japan
A beta 3 adrenoceptor agonist - Mirabegron or Betanis
Pharmaceutical Form:
INN or Proposed INN: Mirabegron
CAS Number: 223673-61-8
Other descriptive name: MIRABEGRON
Concentration type: equal
Concent
Sponsors
The Heart Center, Rigshospitalet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria 1. Stable heart failure NYHA class II-III on ischemic or non-ischemic basis 2. Left ventricular ejection fraction (LVEF) 4 weeks with no current plan for changing HF therapy. The therapy must include a beta-blocker. 5. No change in diuretics 18 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: Exclusion criteria 1. Unstable cardiac condition 2. Acute myocardial infarction (AMI) or revascularisation 1. degree AV-block unless the patient has a pacemaker 10. Clinically significant hepatic (transaminases or bilirubin x 3 above upper reference level) or renal (GFR 35 16. Unable to give informed consent 17. Reduced compliance 18. All women of child bearing potential will be required to use adequate contraception 19. Pregnant or lactating women 20. Treatment with a tricyclic antidepressant or CYP2D6 substrates other than beta-blockers or treatment with dig
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective is to assess if the study drug - Mirabegron - improves myocardial pump function in patients with heart failure Primary endpoint Increase in LVEF (measured by MRI or CT) ;Secondary Objective: Secondary endpoints Combined endpoints including; 1) A reduction in NT proBNP, 2) An increase in 6 min walking distance, 3) An increase in CO/SV, 4) A reduction in LVIDd, 5) An improvement in diastolic function, 6) A reduction in LA volume, 7) An increase in LVEF, 8) A shortening of the QT interval 9) Improvement in quality of life 10) Improvement in functional class ;Primary end point(s): Primary endpoint Increase in LVEF (measured by MRI or CT) ;Timepoint(s) of evaluation of this end point: After 26 weeks treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints Combined endpoints including; 1) A reduction in NT proBNP, 2) An increase in 6 min walking distance, 3) An increase in CO/SV, 4) A reduction in LVIDd, 5) An improvement in diastolic function, 6) A reduction in LA volume, 7) An increase in LVEF, 8) A shortening of the QT interval 9) Improvement in quality of life 10) Improvement in functional class ;Timepoint(s) of evaluation of this end point: After 26 weeks treatment | — |
Countries
Australia, Denmark
Contacts
Public ContactThe Heart Center, Rigshospitalet
The Heart Center, Rigshospitalet
Outcome results
None listed