Status:
COMPLETED
Beta 3 Agonist Treatment in Heart Failure
Lead Sponsor:
Henning Bundgaard
Conditions:
Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Objective: The objective of the study is to assess the structural and functional cardiac effects of treatment with the beta 3 AR agonist Mirabegron in patients with chronic heart failure. Design: The...
Eligibility Criteria
Inclusion
- Stable heart failure NYHA class II-III on ischemic or non-ischemic basis
- Left ventricular ejection fraction (LVEF) \< 40%
- Stable sinus rhythm (SR)
- On optimised evidence-based pharmacological HF treatment stable \> 4 weeks with no current plan for changing HF therapy. The therapy must include a beta-blocker.
- No change in diuretics \< 4 weeks
- \>18 years
Exclusion
- Unstable cardiac condition
- Acute myocardial infarction (AMI) or revascularisation \< 3 month ago
- Atrial fibrillation (for technical reasons in relation to imaging and HR reporting)
- Uncorrected significant primary obstructive valve disease
- Planned major surgery including cardiac revascularisation
- Hemodynamically significant obstructive cardiomyopathy
- Stroke with significant neurological deficit
- Acute myocarditis or constrictive pericarditis
- Symptomatic bradycardia or \> 1. degree AV-block unless the patient has a pacemaker
- Clinically significant hepatic (transaminases or bilirubin x 3 above upper reference level) or renal (GFR\< 50 ml/min/1,73 m2) diseases
- Heart failure due to uncorrected thyroid disease
- Cardiac mechanical support
- \< 6 months after CRT
- Uncontrolled hypotension (defined as symptomatic systolic blood pressure \< 90 mmHg) - or hypertension (defined as systolic at 180 mmHg or above and/or diastolic blood pressure at 110 mmHg or below)
- Body mass index (BMI) \> 35
- Unable to give informed consent
- Reduced compliance
- All women of child bearing potential will be required to use adequate contraception
- Pregnant or lactating women
- Treatment with a tricyclic antidepressant or CYP2D6 substrates other than beta-blockers or treatment with digoxin.
Key Trial Info
Start Date :
September 30 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2015
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01876433
Start Date
September 30 2013
End Date
September 30 2015
Last Update
October 19 2020
Active Locations (3)
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1
Monash Center of Cardiovascular Research.
Melbourne, Australia
2
Department of Cardiology, Royal North Shore Hospital.
Sydney, Australia
3
Department of Cardiology, The Heart Centre, Rigshospitalet Copenhagen University Hospital.
Copenhagen Ø, Denmark, 2100