- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03926754
Beta 3 Agonist Treatment in Heart Failure-2 (BEAT-HF II)
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
- Determine safety of administration of Mirabegron to patients with moderate to severe heart failure.
- 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).
- 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.
- Determine effects of Mirabegron on cardiac conduction, repolarisation and rhythms and arrhythmias in patients with moderate to severe heart failure.
- Determine effects of Mirabegron on circulating biomarkers in patients with moderate to severe heart failure.
- Determine the immediate and short term haemodynamic effects of Mirabron as measured by CT and invasively.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
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-
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Copenhagen, Denmark, 2100
- Rigshospitalet
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Stable heart failure NYHA class III-IV on ischemic or non-ischemic basis
- Left ventricular ejection fraction (LVEF) < 35% as assessed by cardiac CT
- NT proBNP > 1000 pg/ml
- 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.
- No change in diuretics ≤1 week
- No admittances to hospital for treatment with intravenously administered positive inotropic agents ≤ 4 weeks.
- >18 years
Exclusion Criteria:
- Acute myocardial infarction (AMI) or revascularisation < 3 month ago
- Uncorrected significant primary obstructive valve disease
- Planned major surgery including cardiac revascularisation
- Hemodynamically significant obstructive cardiomyopathy
- Acute myocarditis or constrictive pericarditis
- Clinically significant hepatic (transaminases or bilirubin x 3 above upper reference level) or renal (GFR< 30 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 < 80 mmHg) - or hypertension (defined as systolic at 180 mmHg or above and/or diastolic blood pressure at 110 mmHg or below)
- 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.
- Known allergy to iodine containing contrast
- Estimated GFR < 30 ml/min/1.73 m2
- Congenital or drug induced QT prolongation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
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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).
Other Names:
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Active Comparator: Mirabegron
Active treatment arm (mirabegron)
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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).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Increase in left ventricular ejection fraction as measured by computed tomography
Time Frame: 3 months
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Study A
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3 months
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Change in invasive hemodynamics assesses by right heart catherization
Time Frame: At 3 hours and at 1 week
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Study B is explorative assessing the effect on invasive parameters including cardiac output, pulmonary wedge pressure and pulmonary and systemic vascular resistance.
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At 3 hours and at 1 week
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-002367-34
- H-16030780 (Other Identifier: Regional Ethics Committee)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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