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

September 20, 2016 updated by: Mika Lehto

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: From the start of the study to the end of the study; 0 - 12 months
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
Time Frame: From the start of the study to the end of the study; 0 - 12 months
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
Time Frame: From the start of the study to the end of the study; 0 - 12 months
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)
Time Frame: after each 6-month period
after each 6-month period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mika Lehto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • RALF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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