Patients who have a pacemaker due to sinus node disease and paroxysmal atrial fibrillation. MedDRA version: 12.0 Level: LLT Classification code 10067824 Term: Prophylaxis against atrial fibrillation
Conditions
Interventions
Trade Name: Rasilez
Pharmaceutical Form: Tablet
CAS Number: 0
Other descriptive name: ALISKIREN HEMIFUMARATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Ph
Sponsors
Mika Lehto
Eligibility
Sex/Gender
All
Inclusion criteria
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. Inclusion criteria: - 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
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary endpoint of this study is the AF burden measured as mean time (percent-age) of AF seen by the pacemaker during the each 6 months study period with an al-located treatment. AF periods lasting more than 48 hours will not be considered as paroxysmal episodes, and therefore will not be included to the AF burden.;Secondary Objective: The secondary endpoints for this study are the 1) number of AF episodes 2) number of persistent AF episodes lasting more than 48 hours 3) total AF burden including epi-sodes lasting more than 48 hours 4) number of electrical or medical cardioversions 5) time to first persistent AF episode lasting more than 48 hours during each period 6) the number of patients who will have chronic AF 7) number of health-care provider contacts due AF and 8) the length of the paced P-wave measured by high resolution ECG (SAECG) after each period. The pacing site at right atrium will also be taken into consideration in the P-wave analysis. ;Primary end point(s): The primary endpoint of this study is the AF burden measured as mean time (percent-age) of AF seen by the pacemaker during the each 6 months study period with an al-located treatment. AF periods lasting more than 48 hours will not be considered as paroxysmal episodes, and therefore will not be included to the AF burden. | — |
Countries
Finland
Outcome results
None listed