A multi-centre randomized, placebo-controlled trial of mirabegron, a new beta3-adrenergic receptor agonist on the progression of left ventricular mass and diastolic function in patients with structural heart disease

niversité catholique de Louvain (Belgium)0 sites296 target enrollmentOctober 30, 2015

Overview

2018 Protocol article in https://pubmed.ncbi.nlm.nih.gov/29932311/ protocol (added 05/06/2020) 2023 Results article in https://doi.org/10.1001/jamacardio.2023.3003 (added 06/10/2023)

Registry

who.int

Start Date

October 30, 2015

End Date

September 1, 2022

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

niversité catholique de Louvain (Belgium)

•1\. Age between 18 and 90 years
•2\. Arterial hypertension on stable therapy according to current guideline algorithms (including stable medication for at least four weeks before inclusion)
•3\. Morphological signs of structural cardiac remodelling by echocardiography, i.e. increased LV mass index (110 g/m2 or higher for female; 134 g/m2 or higher for male subjects (Devereux, Reichek 1977\)) or end\-diastolic wall thickness \>13 mm in at least one wall segment
•4\. Patients may have atrial fibrillation (AF), but with well\-regulated ventricular response, i.e. heart rate\<100/min at inclusion (RACE II \- (Groenveld et al. 2013, 2013\))
•5\. Written informed consent
•6\. For subjects unable to read and/or write, oral informed consent observed by an independent witness is acceptable if the subject has fully understood oral information given by the Investigator. The witness should sign the consent form on behalf of the subject

•1\. Unstable hypertension with systolic BP\=160 mm Hg and/or diastolic BP\=100 mm Hg (confirmed at three consecutive office measurements in sitting position); if so, the patient may be re\-screened after optimization of anti\-hypertensive treatment, which should be stabilized for at least four weeks before inclusion.
•2\. Documented ischemic cardiac disease:
•2\.1\. current angina pectoris or
•2\.2\. ischemia on stress test or
•2\.3\. untreated coronary stenosis \>50% or
•2\.4\. history of acute myocardial infarction (AMI) or
•2\.5\. coronary artery bypass graft (CABG, \< than 3 months prior to screening) or
•2\.6\. percutaneous transluminal coronary angioplasty (PTCA) less than 3 months prior to screening.
•3\. History of hospitalization for overt heart failure within last 12 months
•4\. Patients after heart transplantation