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

NCT02909166 | Unknown Phase 3

• 1 other identifier: RALF
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• burden of atrial fibrillation

  From the start of the study to the end of the study; 0 - 12 months

Secondary Outcomes (3)

• 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

Study Arms (2)

aliskiren

ACTIVE COMPARATOR

Aliskiren 300 once a day (q.d)

Drug: aliskiren

placebo

PLACEBO COMPARATOR

Placebo once a day (q.d)

Drug: aliskiren

Interventions

aliskiren DRUG

Also known as: Rasilez

aliskiren; placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mika Lehto: lead

Study Sites (1)

Helsinki University Central Hospital

Helsinki, 00029, Finland

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

aliskiren

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mika Lehto, MD, PhD

CONTACT

+358505447487; mika.lehto@hus.fi

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: September 16, 2016
• First Posted: September 21, 2016
• Study Start: January 1, 2012
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: September 21, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)