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Completed

NCT Number: NCT01876433

Beta 3 Agonist Treatment in Heart Failure

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

1. Determine safety of administration of Mirabegron to patients with heart failure. 2. Determine if treatment with Mirabegron for 6 months induces beneficial cardiac structural remodelling in patients with heart failure. 3. Determine if Mirabegron improves symptoms and exercise capacity as indicated by questionnaires and 6 min walk test in patients with heart failure. 4. Determine effects of Mirabegron on cardiac conduction, repolarisation and rhythms and arrhythmias in patients with heart failure. 5. Determine effects of Mirabegron on circulating biomarkers in patients with heart failure.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Monash Center of Cardiovascular Research., Melbourne, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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.

Treatment and study plan

Mirabegron

Drug

Other names: Beta 3 agonist

Placebo

Drug

Primary outcomes

  1. Increase in LVEF (measured by MRI or CT)

    Time frame: 6 months

Secondary outcomes

  1. A reduction in NT proBNP

    Time frame: 6 months

  2. An increase in 6 min walking distance

    Time frame: 6 months

  3. An increase in CO/SV

    Time frame: 6 months

  4. A reduction in LVIDd

    Time frame: 6 months

  5. An improvement in diastolic function

    Time frame: 6 months

  6. A reduction in LA volume

    Time frame: 6 months

  7. A reduction in LV diameters

    Time frame: 6 months

  8. A shortening of the QT interval

    Time frame: 6 months

  9. Improvement in quality of life

    Time frame: 6 monhs

  10. Improvement in functional class

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Henning Bundgaard

Other

Registry information

Acronym: Beat-HF

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 12, 2013
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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