Clinical trial NCT01366703: Optimized Heart Failure Therapy Through Continuous Monitoring
Official title: Optimized Heart Failure Therapy Through Continuous Monitoring. The PHARAO Multi-centre Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Keywords: heart failure
implantable loop recorder
Lead sponsor: Kennemer Gasthuis
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2011-06-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 50 patients with stable heart failure

Brief summary: Patients with heart failure have a high incidence of atrial fibrillation (AF)and re-admission for heart failure. New methods have been developed to continuously monitor arrhythmia's and heart failure parameters. One such method is implantation of an implantable loop recorder. Also home-monitoring is available for continuous monitoring and information sending to the treating physicians, with improving detection of atrial fibrillation (AF) and/or other sever arrhythmia's we hope to improve patient care.

Objective of the study:

To investigate the clinical efficacy in detecting clinically relevant arrhythmia's (especially AF) of the Reveal XT in patients with mild to moderate heart failure and elevated risk factor for stroke and transient ischemic attack (TIA)(CHADS-score \>2), currently not treated with oral anticoagulation (OAC).

Study design:

In 50 stable sinus rhythm (no known AF)patients with New York health Association (NYHA class) 2-3, a CHADS2-score\>2 and no indication for a implantable cardioverter-defibrillator (ICD) or pacemaker (PM) or OAC. Patients are put on home-monitoring (CareLink) and regular outward clinic visits. The number of relevant arrhythmia's detected will count for the primary endpoint. Also the number of medication changes and institution of OAC.

Study population:

50 stable patients, recruited from the outward clinic. NYHA class 2-3. Reveal XT implantation. CHADS2-score 2 or more. No indication for ICD/PM or OAC. No AF known.

Primary study parameters/outcome of the study:

Primary endpoints

* AF burden and AF episodes detected
* Detected other relevant arrhythmia's like SVT's (not AF) or ventricular tachycardias (VT's) or bradycardias
* % patients on OAC after 1 year follow-up
* Number of clinically relevant patient activated events
* Number of treatment policy changes based on the Reveal XT

Secondary study parameters/outcome of the study

* specificity of AF detection algorithm by the Reveal
* Predictive value of the cardiac Compass data to predict worsening heart failure episodes.

Detailed description: no additional description needed

Eligibility criteria: Inclusion Criteria:

* EF \> 35%
* NYHA 2-3
* No AF documented
* Not on OAC

Exclusion Criteria:

* use of OAC
* documented AF \> 30 sec
* planned or actual PM/ICD
* life-expectancy \< 1 year
* no informed consent

Primary outcomes:
measure: registered arrhythmias with implantable loop recorder during follow-up period
timeFrame: 1 year follow-up after last included patient
Secondary outcomes:
measure: prediction of worsening heart failure through cardiac compass
timeFrame: during follow-up (1 year after last included patient)
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate ziekenhuis
city: Deventer
country: Netherlands
facility: Deventer Ziekenhuis
city: Groningen
country: Netherlands
facility: Martini Ziekenhuis
city: Haarlem
country: Netherlands
facility: Kennemer gasthuis
city: Leiderdorp
country: Netherlands
facility: Rijnland Ziekenhuis
Study officials:
affiliation: Kennemer Gasthuis
name: raymond tukkie, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: