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

Atrial Fibrillation Clinical Trial

Official title: 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

Status Recruiting

Clinical Trial Summary

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

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

• NCT number: NCT02909166
• Study type: Interventional
• Source: Helsinki University Central Hospital
• Contact: Mika Lehto, MD, PhD
• Phone: +358505447487
• Email: mika.lehto@hus.fi
• Status: Recruiting
• Phase: Phase 3
• Start date: January 2012
• Completion date: December 2017