None listed
Conditions
Brief summary
The study hypothesizes it's feasible and effective to use intensive BP-lowering to reduce AF burden. In this pilot study of 60 patients with non-permanent AF who have a baseline BP >130/80, we aim to examine whether patients randomized to intensive BP-lowering in addition to usual care will have reduced AF burden as measured by continuous cardiac monitoring using an implanted device. Intensive BP-lowering will be achieved by randomizing patients to the quadpill (single pill with irbesartan 37.5 mg, amlodipine 1.25 mg, indapamide 0.625 mg, and bisoprolol 2.5 mg) or to placebo on top of usual care.
Interventions
A combination of 4 ultra-low dose blood pressure lowering pills (irbesartan 37.5mg, amlodipine 1.25mg, indapamide 0.625mg, bisoprolol 2.5mg) packaged as Dose Administration Aids as initial or add-on treatment in addition to usual care management of blood pressure(BP) with standard BP target as recommended by guidelines. The 4 ultra-low dose blood pressure lowering pill will be taken once daily for 24 weeks. The other antihypertensive treatment is decided by the physicians. The medication adheren
A combination of 4 ultra-low dose blood pressure lowering pills (irbesartan 37.5mg, amlodipine 1.25mg, indapamide 0.625mg, bisoprolol 2.5mg) packaged as Dose Administration Aids as initial or add-on treatment in addition to usual care management of blood pressure(BP) with standard BP target as recommended by guidelines. The 4 ultra-low dose blood pressure lowering pill will be taken once daily for 24 weeks. The other antihypertensive treatment is decided by the physicians. The medication adherence is measured by self-reported measures and drug tablet return.
Sponsors
Western Sydney Local Health District
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed