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Beta 3 Agonist Treatment in Heart Failure (Beat-HF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01876433
Recruitment Status : Unknown
Verified June 2015 by Henning Bundgaard, Rigshospitalet, Denmark.
Recruitment status was:  Recruiting
First Posted : June 12, 2013
Last Update Posted : June 11, 2015
Sponsor:
Collaborators:
Monash Center of Cardiovascular Research, Melbourne, Australia.
Department of Cardiology, Royal North Shore Hospital, Sydney, Australia
Information provided by (Responsible Party):
Henning Bundgaard, Rigshospitalet, Denmark

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: We are planning a study aiming at establishing proof of concept that treatment of patients with HF with Mirabegron has significant positive effects, as assessed by clinical and biochemistry measurements, but not by hard endpoints. We are performing a combined dose-finding - chronic efficacy study.

The study is a randomized, placebo‐controlled, double‐blinded trial. The follow‐up period is 6 months. 70 patients with chronic heartfailure will be included.

Specific aims

  1. Determine safety of administration of Mirabegron to patients with heart failure.
  2. Determine if treatment with Mirabegron for 6 months induces beneficial cardiac structural remodelling in patients with heart failure.
  3. Determine if Mirabegron improves symptoms and exercise capacity as indicated by questionnaires and 6 min walk test in patients with heart failure.
  4. Determine effects of Mirabegron on cardiac conduction, repolarisation and rhythms and arrhythmias in patients with heart failure.
  5. Determine effects of Mirabegron on circulating biomarkers in patients with heart failure.

Condition or disease Intervention/treatment Phase
Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) Drug: Mirabegron Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Beta 3 Agonist Treatment in Heart Failure
Study Start Date : September 2013
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Mirabegron

Arm Intervention/treatment
Active Comparator: Beta-3-agonist
Mirabegron 25 mg x 2 titrated up to maximal tolerated dosis or a maximum of 150 mg x 2.
Drug: Mirabegron
Other Name: Beta 3 agonist

Placebo Comparator: Placebo
Placebo 25 mg x 2 titrated up to maximal tolerated dosis or a maximum of 150 mg x 2.
Drug: Placebo



Primary Outcome Measures :
  1. Increase in LVEF (measured by MRI or CT) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. A reduction in NT proBNP [ Time Frame: 6 months ]
  2. An increase in 6 min walking distance [ Time Frame: 6 months ]
  3. An increase in CO/SV [ Time Frame: 6 months ]
  4. A reduction in LVIDd [ Time Frame: 6 months ]
  5. An improvement in diastolic function [ Time Frame: 6 months ]
  6. A reduction in LA volume [ Time Frame: 6 months ]
  7. A reduction in LV diameters [ Time Frame: 6 months ]
  8. A shortening of the QT interval [ Time Frame: 6 months ]
  9. Improvement in quality of life [ Time Frame: 6 monhs ]
  10. Improvement in functional class [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Stable heart failure NYHA class II-III on ischemic or non-ischemic basis
  2. Left ventricular ejection fraction (LVEF) < 40%
  3. Stable sinus rhythm (SR)
  4. 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.
  5. No change in diuretics < 4 weeks
  6. >18 years

Exclusion Criteria:

  1. Unstable cardiac condition
  2. Acute myocardial infarction (AMI) or revascularisation < 3 month ago
  3. Atrial fibrillation (for technical reasons in relation to imaging and HR reporting)
  4. Uncorrected significant primary obstructive valve disease
  5. Planned major surgery including cardiac revascularisation
  6. Hemodynamically significant obstructive cardiomyopathy
  7. Stroke with significant neurological deficit
  8. Acute myocarditis or constrictive pericarditis
  9. Symptomatic bradycardia or > 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< 50 ml/min/1,73 m2) diseases
  11. Heart failure due to uncorrected thyroid disease
  12. Cardiac mechanical support
  13. < 6 months after CRT
  14. 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)
  15. Body mass index (BMI) > 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 digoxin.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01876433


Contacts
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Contact: Henning Bundgaard, MD, DMSci +4535450512 henningbundgaard@dadlnet.dk

Locations
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Australia
Monash Center of Cardiovascular Research. Not yet recruiting
Melbourne, Australia
Contact: Henry Krum, MD, Professor         
Principal Investigator: Henry Krum, MD, Professor         
Department of Cardiology, Royal North Shore Hospital. Not yet recruiting
Sydney, Australia
Contact: Helge Rasmussen, MD, Professor         
Principal Investigator: Helge Rasmussen, MD, Professor         
Denmark
Department of Cardiology, The Heart Centre, Rigshospitalet Copenhagen University Hospital. Recruiting
Copenhagen Ø, Denmark, 2100
Contact: Henning Bundgaard, MD, DMSci    +4535450512    henningbundgaard@dadlnet.dk   
Principal Investigator: Henning Bundgaard, MD, PhD, DMSc         
Sponsors and Collaborators
Henning Bundgaard
Monash Center of Cardiovascular Research, Melbourne, Australia.
Department of Cardiology, Royal North Shore Hospital, Sydney, Australia
Investigators
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Principal Investigator: Henning Bundgaard, MD, PhD, DMSc Rigshospitalet Copenhagen University Hospital, Department of Cardiology
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Henning Bundgaard, Consultant, dr. med., Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01876433    
Other Study ID Numbers: 2012-004805-29
First Posted: June 12, 2013    Key Record Dates
Last Update Posted: June 11, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Mirabegron
Adrenergic beta-3 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents