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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

Beta 3 Agonist Treatment in Heart Failure-2

Clinicaltrials.gov identifier NCT03926754

Recruitment Status Enrolling by invitation

First Posted April 24, 2019

Last update posted October 19, 2020

Study Description

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:Heart Failure With Reduced Ejection Fraction NYHA Class III-IV
  • Intervention/Treatment: Drug: Mirabegron
  • Phase: Phase 2/Phase 3
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • 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 2017
  • Estimated Primary Completion Date: December 2020
  • Estimated Study Completion Date: December 2020
Arms and interventions
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).
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).
Outcome Measures
  • 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.
Eligibility Criteria
  • 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) 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

Contacts and Locations
Contacts
Locations

Denmark
Rigshospitalet
Copenhagen

Sponsors and Collaborators

Henning Bundgaard

Bispebjerg-Frederiksberg Hospital, Denmark

Hillerød hospital, Denmark

Herlev Hospital

Hvidovre University Hospital

Bornholm Hospital, Denmark

Royal North Shore Hospital

More Information