Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)Phase 2Beat-HFNCT01876433
Beta 3 Agonist Treatment in Heart Failure
A Phase 2 study testing Mirabegron in people with Chronic Heart Failure With Reduced Ejection Fraction (HFrEF), run by Henning Bundgaard at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)
- What is being tested?
- Mirabegron
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 30 Sep 2013to 30 Sep 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Australia2 sites
Monash Center of Cardiovascular Research.
Melbourne
Department of Cardiology, Royal North Shore Hospital.
Sydney
Denmark1 site
Department of Cardiology, The Heart Centre, Rigshospitalet Copenhagen University Hospital.
Copenhagen Ø, 2100
About this study
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.
Read more
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
- Determine safety of administration of Mirabegron to patients with heart failure.
- Determine if treatment with Mirabegron for 6 months induces beneficial cardiac structural remodelling in patients with heart failure.
- Determine if Mirabegron improves symptoms and exercise capacity as indicated by questionnaires and 6 min walk test in patients with heart failure.
- Determine effects of Mirabegron on cardiac conduction, repolarisation and rhythms and arrhythmias in patients with heart failure.
- Determine effects of Mirabegron on circulating biomarkers in patients with heart failure.
- Being tested
- Mirabegron, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MirabegronDrug
Also called Beta 3 agonist
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Beta-3-agonist | Active comparator | Mirabegron 25 mg x 2 titrated up to maximal tolerated dosis or a maximum of 150 mg x 2. Receives: Drug: Mirabegron |
| Placebo | Placebo comparator | Placebo 25 mg x 2 titrated up to maximal tolerated dosis or a maximum of 150 mg x 2. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in LVEF (measured by MRI or CT)
Measured: 6 months
Secondary outcomes (10)
A reduction in NT proBNP
Measured: 6 months
An increase in 6 min walking distance
Measured: 6 months
An increase in CO/SV
Measured: 6 months
A reduction in LVIDd
Measured: 6 months
An improvement in diastolic function
Measured: 6 months
A reduction in LA volume
Measured: 6 months
A reduction in LV diameters
Measured: 6 months
A shortening of the QT interval
Measured: 6 months
Improvement in quality of life
Measured: 6 monhs
Improvement in functional class
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2013 (estimated)
- Study start30 Sep 2013
- Primary completion30 Sep 2015
- Study completion30 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henning Bundgaard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Henning Bundgaard, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Henning Bundgaard, MD, PhD, DMSc, Principal investigator, Rigshospitalet Copenhagen University Hospital, Department of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01876433
- Sponsor's protocol ID
- 2012-004805-29
- Acronym
- Beat-HF
- Status last verified
- Oct 2020
- First submitted
- 10 Jun 2013
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bahrami HSZ, Hasselbalch RB, Soholm H, Thomsen JH, Sorgaard M, Kofoed KF, Valeur N, Boesgaard S, Fry NAS, Moller JE, Raja AA, Kober L, Iversen K, Rasmussen H, Bundgaard H. First-In-Man Trial of beta3-Adrenoceptor Agonist Treatment in Chronic Heart Failure: Impact on Diastolic Function. J Cardiovasc Pharmacol. 2024 May 1;83(5):466-473. doi: 10.1097/FJC.0000000000001545.
PubMed 38452283Bundgaard 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.
PubMed 27990717
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beta 3 Agonist Treatment in Heart Failure
- ClinicalTrials.gov ID
- NCT01876433
- Acronym / sponsor ID
- Beat-HF / 2012-004805-29
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Henning BundgaardUniversity, hospital or other
- Study start
- 30 Sep 2013 (actual)
- Primary completion
- 30 Sep 2015 (actual)
- Study completion
- 30 Sep 2015 (actual)
- First posted
- 12 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Determine safety of administration of Mirabegron to patients with heart failure.
- Determine if treatment with Mirabegron for 6 months induces beneficial cardiac structural remodelling in patients with heart failure.
- Determine if Mirabegron improves symptoms and exercise capacity as indicated by questionnaires and 6 min walk test in patients with heart failure.
- Determine effects of Mirabegron on cardiac conduction, repolarisation and rhythms and arrhythmias in patients with heart failure.
- Determine effects of Mirabegron on circulating biomarkers in patients with heart failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beta-3-agonist | Active comparator | Drug: MirabegronMirabegron 25 mg x 2 titrated up to maximal tolerated dosis or a maximum of 150 mg x 2. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 25 mg x 2 titrated up to maximal tolerated dosis or a maximum of 150 mg x 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MirabegronAlso: Beta 3 agonist | Drug | Beta-3-agonist |
| Placebo | Drug | Placebo |
Primary outcome
Increase in LVEF (measured by MRI or CT)
Time frame: 6 months
10 secondary outcomes
A reduction in NT proBNP
Time frame: 6 months
An increase in 6 min walking distance
Time frame: 6 months
An increase in CO/SV
Time frame: 6 months
A reduction in LVIDd
Time frame: 6 months
An improvement in diastolic function
Time frame: 6 months
A reduction in LA volume
Time frame: 6 months
A reduction in LV diameters
Time frame: 6 months
A shortening of the QT interval
Time frame: 6 months
Improvement in quality of life
Time frame: 6 monhs
Improvement in functional class
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Derived from this study: PubMed 38452283Bahrami HSZ, Hasselbalch RB, Soholm H, Thomsen JH, Sorgaard M, Kofoed KF, Valeur N, Boesgaard S, Fry NAS, Moller JE, Raja AA, Kober L, Iversen K, Rasmussen H, Bundgaard H. First-In-Man Trial of beta3-Adrenoceptor Agonist Treatment in Chronic Heart Failure: Impact on Diastolic Function. J Cardiovasc Pharmacol. 2024 May 1;83(5):466-473. doi: 10.1097/FJC.0000000000001545.
- Derived from this study: PubMed 27990717Bundgaard 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henning Bundgaard, MD, PhD, DMSc principal investigator
Rigshospitalet Copenhagen University Hospital, Department of Cardiology
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mirabegron in people with Chronic Heart Failure With Reduced Ejection Fraction (HFrEF), run by Henning Bundgaard at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in LVEF (measured by MRI or CT) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01876433, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.