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

Primary Purpose

Atrial Fibrillation

Status
Unknown status
Phase
Phase 3
Locations
Finland
Study Type
Interventional
Intervention
aliskiren
Sponsored by
Mika Lehto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Helsinki University Central HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

aliskiren

placebo

Arm Description

Aliskiren 300 once a day (q.d)

Placebo once a day (q.d)

Outcomes

Primary Outcome Measures

burden of atrial fibrillation

Secondary Outcome Measures

number of AF episodes
number of persistent AF episodes lasting more than 48 hours
the length of the paced P-wave measured by high resolution ECG (SAECG)

Full Information

First Posted
September 16, 2016
Last Updated
September 20, 2016
Sponsor
Mika Lehto
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1. Study Identification

Unique Protocol Identification Number
NCT02909166
Brief Title
Role of ALiskiren, a Direct Renin Inhibitor, in Preventing Atrial Fibrillation in Patients With a Pacemaker; RALF.
Acronym
RALF
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mika Lehto

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
aliskiren
Arm Type
Active Comparator
Arm Description
Aliskiren 300 once a day (q.d)
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo once a day (q.d)
Intervention Type
Drug
Intervention Name(s)
aliskiren
Other Intervention Name(s)
Rasilez
Primary Outcome Measure Information:
Title
burden of atrial fibrillation
Time Frame
From the start of the study to the end of the study; 0 - 12 months
Secondary Outcome Measure Information:
Title
number of AF episodes
Time Frame
From the start of the study to the end of the study; 0 - 12 months
Title
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
Title
the length of the paced P-wave measured by high resolution ECG (SAECG)
Time Frame
after each 6-month period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mika Lehto, MD, PhD
Phone
+358505447487
Email
mika.lehto@hus.fi
Facility Information:
Facility Name
Helsinki University Central Hospital
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mika Lehto, MD, PhD
Phone
+358505447487
Email
mika.lehto@hus.fi
First Name & Middle Initial & Last Name & Degree
Jussi Niiranen, MD
Email
jussi.niiranen@hus.fi

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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