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Beta 3 Agonist Treatment in Heart Failure-2 (BEAT-HF II)

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: NCT03926754
Recruitment Status : Enrolling by invitation
First Posted : April 24, 2019
Last Update Posted : April 24, 2019
Sponsor:
Collaborators:
Bispebjerg-Frederiksberg Hospital, Denmark
Hillerød hospital, Denmark
Herlev Hospital
Hvidovre University Hospital
Bornholm Hospital, Denmark
Royal North Shore Hospital
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 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.

Condition or disease Intervention/treatment Phase
Heart Failure With Reduced Ejection Fraction NYHA Class III-IV Drug: Mirabegron Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 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-2
Actual Study Start Date : January 23, 2017
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Active Comparator: Mirabegron
Active treatment arm (mirabegron)
Drug: Mirabegron

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 Name: Placebo

Placebo Comparator: Placebo
Placebo
Drug: Mirabegron

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 Name: Placebo




Primary Outcome Measures :
  1. Increase in left ventricular ejection fraction as measured by computed tomography [ Time Frame: 3 months ]
    Study A

  2. Change in invasive hemodynamics assesses by right heart catherization [ Time Frame: At 3 hours and at 1 week ]
    Study B is explorative assessing the effect on invasive parameters including cardiac output, pulmonary wedge pressure and pulmonary and systemic vascular resistance.



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 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:

  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

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): NCT03926754


Locations
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Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Henning Bundgaard
Bispebjerg-Frederiksberg Hospital, Denmark
Hillerød hospital, Denmark
Herlev Hospital
Hvidovre University Hospital
Bornholm Hospital, Denmark
Royal North Shore Hospital
Publications:
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Responsible Party: Henning Bundgaard, Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03926754    
Other Study ID Numbers: 2016-002367-34
H-16030780 ( Other Identifier: Regional Ethics Committee )
First Posted: April 24, 2019    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
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