Role of ALiskiren, a Direct Renin Inhibitor, in Preventing Atrial Fibrillation in Patients With a Pacemaker; RALF.

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study is to find out whether aliskiren reduces atrial fibrillation burden measured with a pacemaker device

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mika Lehto

Criteria

Inclusion Criteria:

• age between 18 and 85 years

• sinus node disease and paroxysmal AF

• provided signed informed consent according to the Declaration of Helsinki for study participation

• a previously implanted St. Jude Medical Identity / Victory / Zephyr ADX or any newer model of SJM DDDR pacemaker with ability to record high atrial rates

Exclusion Criteria:

• contraindication for the use of aliskiren

• severe impairment of renal function (serum creatinine > 160 µmol/L) or patient with solitary kidney or renal transplant or renal artery stenosis

• significant known aortic or mitral valve stenosis or obstructive hypertrophic cardiomyopathy

• hypersensitivity to aliskiren or to any of the excipients

• concomitant treatment with cyclosporine

• patients with uncontrolled hypertension requiring treatment for hypertension

• systolic blood pressure measured in two separate occasions ≥ 160 mmHg

• diastolic blood pressure in two separate occasions ≥ 100 mmHg

• absolute indication for the use of an RAAS blocker

• chronic, persisting AF (persisting AF at screening with ≥ 4 cardioversions performed beforehand)

• sitting systolic arterial blood pressure of less than 100 mm Hg at the time of randomisation

• need for ventricular pacing more than 30% at the enrolment

• pregnancy and/or lactation

• women of childbearing potential (only postmenopausal women or women after tubal ligation will be allowed)

• other serious disease expected to cause substantial deterioration of patient's health during the next two years

• past or present alcohol or drug abuse

• participation in other clinical trials during the last three months

• suspicion of poor study compliance