Atrial Fibrillation and Intensive Blood pressure lowering Pilot Study

Phase 3

• Conditions: Atrial fibrillation; Hypertension; Cardiovascular - Hypertension; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12619000188134
• Lead Sponsor: Western Sydney Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-11
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

•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
•A measure of Clinic SBP greater than or equal to 130 and/ or DBP greater than or equal to 80 mmHg documented on the electronic medical record in the last 6 months or by study staff
•With no intention to change antiarrhythmic therapy in the coming 1 year

Exclusion Criteria

•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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified