Effect of Intensive Blood Pressure Control on the Burden of Atrial Fibrillation in Patientswith Non-permanent Atrial Fibrillation – Feasibility study

Western Sydney Local Health District0 sites60 target enrollmentFebruary 11, 2019

Overview

No summary available.

Registry

who.int

Start Date

February 11, 2019

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

•Patients with non\-permanent AF:
•\-Patients with paroxysmal AF (PAF) with AF burden greater than or equal to 1% or AF duration \>10 minutes in the preceding 6 months identified either by:
•A 5\-7 day Holter monitor
•An in\-situ loop recorder (ILR)
•An intracardiac device (pacemaker \[PPM] or implanted cardiac defibrillator \[ICD])
•\-Patients with an episode of persistent AF (PeAF) cardioverted to sinus rhythm in the last 12 months
•Adults greater than or equal to 18 years
•Continuous rhythm monitoring possible:
•\-pre\-existing ILR, PPM or ICD, or
•\-Consent to having an ILR insertion

•Hypertensive crisis by medical judgement
•Patients that are scheduled to have catheter ablation in the next 3 months
•Contraindication to irbesartan, amlodipine, indapamide or bisoprolol
•Women who are pregnant, breast feeding and/ or of childbearing potential and not using effective contraception throughout the study (pharmacological or barrier methods)
•Concomitant illness, physical impairment or mental condition which in the opinion of the study team/ primary care physician could interfere with the conduct of the study including outcome assessments
•Participation in a concurrent clinical trial of an investigational medical product which will interfere with blood pressure.
•Inability or unwillingness to provide written informed consent
•Medical illness with anticipated life expectancy \< 3 months
•Responsible primary care or other responsible physician believes it is not appropriate to participate in the study or unable to complete the study procedures, e.g. secondary hypertension, resistant hypertension, some concomitant illness, physical impairment or mental condition which could interfere with the conduct of the study including outcome assessments.