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

Role of ALiskiren, a Direct Renin Inhibitor, in Preventing Atrial Fibrillation in Patients With a Pacemaker; RALF. A Double-blind, Randomized, Parallel-group, Single Centre Study

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

Study Overview

• Status: Unknown
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Drug: aliskiren

Detailed Description

The aim of the study is to find out the effect of a direct renin inhibitor, aliskiren, in reduction of AF with patients who have a pacemaker due to sinus node disease and paroxysmal atrial fibrillation.

Hypothesis is that there is a possibility to reduce atrial remodeling due to AF and also to enhance atrial reverse remodeling with aliskiren. The effect of aliskiren to total AF burden will be evaluated from the pacemaker's memory storage.

The main purpose of the study is to find new and safe drug treatments targeting to reduce AF recurrences and related complications in pacemaker patients. Also the aim is to evaluate the feasibility of a modern and highly sophisticated pacemaker system in the evaluation of drug treatment with AF reduction.

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Phase 3

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland, 00029
    • Recruiting
    • Helsinki University Central Hospital
    • Contact: Mika Lehto, MD, PhD; Phone Number: +358505447487; Email: mika.lehto@hus.fi
    • Contact: Jussi Niiranen, MD; Email: jussi.niiranen@hus.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: aliskiren; Aliskiren 300 once a day (q.d)	Drug: aliskiren; Other Names: Rasilez
Placebo Comparator: placebo; Placebo once a day (q.d)	Drug: aliskiren; Other Names: Rasilez

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
burden of atrial fibrillation	From the start of the study to the end of the study; 0 - 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
number of AF episodes	From the start of the study to the end of the study; 0 - 12 months
number of persistent AF episodes lasting more than 48 hours	From the start of the study to the end of the study; 0 - 12 months
the length of the paced P-wave measured by high resolution ECG (SAECG)	after each 6-month period

Collaborators and Investigators

• Sponsor: Mika Lehto

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: September 16, 2016
• First Submitted That Met QC Criteria: September 20, 2016
• First Posted (Estimate): September 21, 2016

Study Record Updates

• Last Update Posted (Estimate): September 21, 2016
• Last Update Submitted That Met QC Criteria: September 20, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: RALF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No