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

Atrial Fibrillation Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02909166
• Other study ID #: RALF
• Status: Recruiting
• Phase: Phase 3
• First received: September 16, 2016
• Last updated: September 20, 2016
• Start date: January 2012
• Est. completion date: December 2017

Study information

• Verified date: September 2016
• Source: Helsinki University Central Hospital
• Contact: Mika Lehto, MD, PhD
• Phone: +358505447487
• Email: mika.lehto[@]hus.fi
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 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

Intervention

Drug:
• aliskiren

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Mika Lehto

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	burden of atrial fibrillation		From the start of the study to the end of the study; 0 - 12 months	Yes
Secondary	number of AF episodes		From the start of the study to the end of the study; 0 - 12 months	No
Secondary	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	No
Secondary	the length of the paced P-wave measured by high resolution ECG (SAECG)		after each 6-month period	No