Clinical trial NCT02864771: Scandinavian Multicenter Study to Advance Risk Stratification in Heart Disease- Ventricular Arrhythmias
Official title: Scandinavian Multicenter Study to Advance Risk Stratification in Heart Disease- Ventricular Arrhythmias: A Multicenter, Observational Trial
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Ventricular Arrhythmias
Implantable Defibrillator User
Biological Markers
Heart Disease
Keywords: Ventricular Arrhythmias
ICD
Biological markers
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
Collaborators: name: Helse Stavanger HF
name: University of Oslo
First posted: 2016-08-12
Enrollment: 504
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: Patients treated with an ICD. Inclusion from outpatient clinic.

Brief summary: The purpose of this study is to identify markers of increased risk for incident ventricular arrhythmias and cardiovascular events in patients already being treated with an implantable cardioverter-defibrillator (ICD) by exploring patient history and clinical findings, biological markers, ECG markers, and echocardiographic markers.

Detailed description: This is a multicenter prospective cohort study to assess the prognostic value of potential biomarkers for incident ventricular arrhythmias and cardiovascular events in patients with implantable cardioverter-defibrillator (ICD). In addition to information from the baseline visit and future study visits, the investigators will also register information from the patients medical records concerning comorbidities and previous medical events.

The data will be summarized with respect to demographic and baseline characteristics and risk markers/ measurements. The final diagnosis of incident cardiovascular events will be established by an adjudication committee with two senior physicians reviewing all information available on the patients, including information on the clinical outcome of the patient. The investigators will use multivariate statistical models to assess the individual performance of biomarkers/other tests.

Eligibility criteria: Inclusion Criteria:

* Patients ≥ 18 years old
* Current treatment with an ICD
* Signed written informed consent before study commencement

Exclusion Criteria:

* Participation in other interventional clinical trial or previously included in the current study
* Patients not able to provide written informed consent
* Known or suspected, non-curable cancer,
* Neurological condition with short life expectancy; e.g. amyotropic lateral sclerosis (ALS)
* Patients unwilling or unable to comply with the protocol
* History of non-compliance to medical management and patients who are considered potentially unreliable by the Investigator
* History or evidence of alcohol or drug abuse with the last 12 months that may influence the participation of the patient in the study, as assessed by the Investigator during the screening phase
* Any surgical or medical condition, which in the option of the Investigator, will impair the ability of the patient to participate in the study

Primary outcomes:
measure: Episodes of ventricular fibrillation (VF) or ventricular tachycardia (VT) resulting in appropriately delivered ICD therapies (including antitachycardia pacing) or sustained ventricular tachyarrhythmia (>100/min, >30sek).
timeFrame: Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.
Secondary outcomes:
measure: All-cause mortality
timeFrame: Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.
measure: Cardiovascular mortality
timeFrame: Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.
measure: Major adverse cardiac event (MACE), i.e. acute myocardial infarction, stroke, urgent myocardial revascularization and cardiovascular mortality
timeFrame: Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.
measure: Heart failure hospitalization
timeFrame: Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.
measure: The combination of cardiovascular mortality and heart failure hospitalizations
timeFrame: Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.
measure: Number of premature ventricular complexes (PVCs) and non-sustained VT (> 3 coupled PVCs) registered from the monitoring function of the ICD
timeFrame: Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.
measure: New occurrence of supra-ventricular arrhythmias (i.e. atrial fibrillation, atrial flutter, atrial tachycardia etc.)
timeFrame: Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.
measure: Episodes of ventricular- or supra-ventricular arrhythmias (specified above) registered from the monitoring function of the ICD.
timeFrame: Duration of follow-up will be a minimum of 180 days following inclusion of the final patient.
Other outcomes:
Locations:
city: Lørenskog
country: Norway
facility: Akershus University Hospital
Study officials:
affiliation: Professor of Medicine
name: Torbjørn Omland, MD,PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: