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CompletedNCT03926754BEAT-HF IIUpdated May 4, 2022

Beta 3 Agonist Treatment in Heart Failure-2

A Phase 2/3 interventional study of Mirabegron in Heart Failure With Reduced Ejection Fraction NYHA Class III-IV, sponsored by Henning Bundgaard. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-04.

Sponsored by Henning Bundgaard · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Jan 2017, registered Jul 2017).
Phase
Phase 2/3
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 moderate to severe chronic heart failure (LVEF\<35%, NYHA III-IV).

The study is a randomized, placebo-controlled, double-blinded trial in two phases with two hypotheses:

Chronic study - study A: Long-term treatment (3 months) with the β3 adrenergic receptor agonist Mirabegron is beneficial in patients with moderate to severe human heart failure

Invasive study - Study B: Administration of Mirabegron in patients with heart failure leads to an immediate increase in cardiac output at a constant or reduced left ventricular filling pressure during submaximal exercise

Specific aims

  1. Determine safety of administration of Mirabegron to patients with moderate to severe heart failure.
  2. Determine if treatment with Mirabegron for 3 months induces beneficial cardiac structural remodelling in patients with moderate to severe heart failure. In an open-label follow-up to determine the effects of Mirabegron after an extended duration (a total of 12 months).
  3. Determine if Mirabegron improves symptoms and exercise capacity as indicated by questionnaires and 6 min walk test in patients with moderate to severe heart failure.
  4. Determine effects of Mirabegron on cardiac conduction, repolarisation and rhythms and arrhythmias in patients with moderate to severe heart failure.
  5. Determine effects of Mirabegron on circulating biomarkers in patients with moderate to severe heart failure.
  6. Determine the immediate and short term haemodynamic effects of Mirabron as measured by CT and invasively.
02

Conditions studied

  • Heart Failure With Reduced Ejection Fraction NYHA Class III-IV
03

In context

Lead sponsor

Henning Bundgaard is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Stable heart failure NYHA class III-IV on ischemic or non-ischemic basis
  2. Left ventricular ejection fraction (LVEF) \< 35% as assessed by cardiac CT
  3. NT proBNP > 1000 pg/ml
  4. On optimised evidence-based pharmacological HF treatment stable ≥2 weeks with no current plan for changing HF therapy. The therapy must include a beta-blocker.
  5. No change in diuretics ≤1 week
  6. No admittances to hospital for treatment with intravenously administered positive inotropic agents ≤ 4 weeks.
  7. >18 years

Exclusion criteria

Exclusion Criteria:

  1. Acute myocardial infarction (AMI) or revascularisation \< 3 month ago
  2. Uncorrected significant primary obstructive valve disease
  3. Planned major surgery including cardiac revascularisation
  4. Hemodynamically significant obstructive cardiomyopathy
  5. Acute myocarditis or constrictive pericarditis
  6. Clinically significant hepatic (transaminases or bilirubin x 3 above upper reference level) or renal (GFR\< 30 ml/min/1,73 m2) diseases
  7. Heart failure due to uncorrected thyroid disease
  8. Cardiac mechanical support
  9. \< 6 months after CRT
  10. Uncontrolled hypotension (defined as symptomatic systolic blood pressure \< 80 mmHg) - or hypertension (defined as systolic at 180 mmHg or above and/or diastolic blood pressure at 110 mmHg or below)
  11. Unable to give informed consent
  12. Reduced compliance
  13. All women of child bearing potential will be required to use adequate contraception
  14. Pregnant or lactating women
  15. Treatment with a tricyclic antidepressant or CYP2D6 substrates other than beta-blockers or treatment with digoxin.
  16. Known allergy to iodine containing contrast
  17. Estimated GFR \< 30 ml/min/1.73 m2
  18. Congenital or drug induced QT prolongation
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
56 participants (actual)

Study arms

  • Active comparator
    Mirabegron

    Active treatment arm (mirabegron)

    Drug: Mirabegron

  • Placebo comparator
    Placebo

    Placebo

    Drug: Mirabegron

Interventions

  • DrugMirabegron

    Study A The maximum tolerated dose up to a maximum of 300 mg per day for 26 weeks. Study B One single dose of 300 mg at day one followed by 150 mg x 2 for 1 week (8-11 days).

    Also known as: Placebo

06

What researchers measure

Primary outcomes

  1. Increase in left ventricular ejection fraction as measured by computed tomography

    Study A

    Time frame: 3 months

  2. Change in invasive hemodynamics assesses by right heart catherization

    Study B is explorative assessing the effect on invasive parameters including cardiac output, pulmonary wedge pressure and pulmonary and systemic vascular resistance.

    Time frame: At 3 hours and at 1 week

07

Study locations

1 site
  • Rigshospitalet
    Copenhagen, 2100, Denmark
08

References and documents

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. PubMed 27990717 ↗

Individual participant data

Plan to share: Undecided — Because of the sensitive nature of the data collected for this study, requests to access the dataset from qualified researchers trained in human subject confidentiality protocols may be sent to the principal investigator.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2017 to primary completion in Jan 2021, 47 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 4, 2017
First posted
Apr 24, 2019
StartActual
Jan 23, 2017
Primary completionActual
Jan 21, 2021
CompletionActual
Jan 21, 2021
Last update
May 4, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03926754
Lead sponsor
Henning Bundgaard
Collaborators
University Hospital Bispebjerg and Frederiksberg, Hillerød hospital, Denmark, Herlev Hospital, Hvidovre University Hospital, Bornholm Hospital, Denmark, Royal North Shore Hospital
Responsible party
Henning Bundgaard (Professor, Copenhagen University Hospital, Rigshospitalet) — Sponsor-investigator
First posted
Apr 24, 2019
Start date
Jan 23, 2017
Primary completion
Jan 21, 2021
Completion
Jan 21, 2021
Last update
May 4, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Mirabegron

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