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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01876433




Registration number
NCT01876433
Ethics application status
Date submitted
10/06/2013
Date registered
12/06/2013
Date last updated
19/10/2020

Titles & IDs
Public title
Beta 3 Agonist Treatment in Heart Failure
Scientific title
Beta 3 Agonist Treatment in Heart Failure
Secondary ID [1] 0 0
2012-004805-29
Universal Trial Number (UTN)
Trial acronym
Beat-HF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Active comparator: Beta-3-agonist - Mirabegron 25 mg x 2 titrated up to maximal tolerated dosis or a maximum of 150 mg x 2.

Placebo comparator: Placebo - Placebo 25 mg x 2 titrated up to maximal tolerated dosis or a maximum of 150 mg x 2.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Increase in LVEF (measured by MRI or CT)
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
A reduction in NT proBNP
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
An increase in 6 min walking distance
Timepoint [2] 0 0
6 months
Secondary outcome [3] 0 0
An increase in CO/SV
Timepoint [3] 0 0
6 months
Secondary outcome [4] 0 0
A reduction in LVIDd
Timepoint [4] 0 0
6 months
Secondary outcome [5] 0 0
An improvement in diastolic function
Timepoint [5] 0 0
6 months
Secondary outcome [6] 0 0
A reduction in LA volume
Timepoint [6] 0 0
6 months
Secondary outcome [7] 0 0
A reduction in LV diameters
Timepoint [7] 0 0
6 months
Secondary outcome [8] 0 0
A shortening of the QT interval
Timepoint [8] 0 0
6 months
Secondary outcome [9] 0 0
Improvement in quality of life
Timepoint [9] 0 0
6 monhs
Secondary outcome [10] 0 0
Improvement in functional class
Timepoint [10] 0 0
6 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/09/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/09/2015
Sample size
Target
Accrual to date
Final
70
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Monash Center of Cardiovascular Research. - Melbourne
Recruitment hospital [2] 0 0
Department of Cardiology, Royal North Shore Hospital. - Sydney
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
Denmark
State/province [1] 0 0
Copenhagen Ø

Funding & Sponsors
Primary sponsor type
Other
Name
Henning Bundgaard
Address
Country

Ethics approval
Ethics application status

Summary
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 investigators 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. The investigators 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 heart failure 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.
Trial website
https://clinicaltrials.gov/study/NCT01876433
Trial related presentations / publications
Bundgaard H, Axelsson A, Hartvig Thomsen J, Sorgaard M, Kofoed KF, Hasselbalch R, Fry NA, Valeur N, Boesgaard S, Gustafsson F, Kober L, Iversen K, Rasmussen HH. The first-in-man randomized trial of a beta3 adrenoceptor agonist in chronic heart failure: the BEAT-HF trial. Eur J Heart Fail. 2017 Apr;19(4):566-575. doi: 10.1002/ejhf.714. Epub 2016 Dec 18.
Public notes

Contacts
Principal investigator
Name 0 0
Henning Bundgaard, MD, PhD, DMSc
Address 0 0
Rigshospitalet Copenhagen University Hospital, Department of Cardiology
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01876433