Role of ALiskiren, a direct renin inhibitor, in preventing atrial Fibrillation in patients with a pacemaker; RALFEteisvärinäkuorman määritys sydämentahdistimella aliskireenihoidossa - RALF

Phase 1

• Conditions: Patients who have a pacemaker due to sinus node disease and paroxysmal atrial fibrillation.; MedDRA version: 12.0Level: LLTClassification code 10067824Term: Prophylaxis against atrial fibrillation

• Registration Number: EUCTR2009-016077-14-FI
• Lead Sponsor: Mika Lehto

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-10
• Last Update Posted: 7 May 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

The study population is patients from HUCH pacemaker policlinics with an earlier im-planted pacemaker because of sinus node disease and paroxysmal AF. It is antici-pated to enrol 70 patients aged 18-80 years to this study during 9 months. The follow-ing inclusion and exclusion criteria will be used for this study.

- age between 18 and 80 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 / Accent / Anthem DDDR DDDR pacemaker with ability to record high atrial rates

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 randomisa-tion
- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified