Ventricular Tachyarrhythmia Detection by Implantable Loop Recording in Patients With Heart Failure and Preserved Ejection Fraction

Study Overview
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Brief Summary
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Heart failure with preserved ejection fraction (HFPEF) is a large medical problem, for which no drug or device has a recommendation in current heart failure guidelines. Sudden cardiac death is suggested as the most common cause of death in HFPEF patients, although data is sparse. Use of an Implantable Loop Recorder (ILR) may be useful in patients with HFPEF to evaluate the incidence of sustained ventricular tachyarrhythmias. If ventricular tachyarrhythmias are seem frequently, treatment with an Implantable Cardioverter Defibrillator (ICD) may be an option in the future.

Official Title
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Ventricular Tachyarrhythmia Detection by Implantable Loop Recording in Patients With Heart Failure and Preserved Ejection Fraction (VIP-HF)

Conditions
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Heart Failure With Preserved Ejection Fraction (HFpEF)

Intervention / Treatment
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* Device: ILR implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical criteria: Age >18 years Written informed consent HF with moderate to severe symptoms NYHA II or III Hospitalization or emergency room visit for HF or symptom relief with diuretics within 12 months Sinus rhythm or AF Echocardiographic criteria: LVEF >40% Left atrial size (volume ≥34 mL/m2 or LA parasternal diameter ≥45), or left ventricular hypertrophy (septal thickness or posterior wall thickness ≥11 mm) or LV diastolic dysfunction (E/e' ≥13 or mean e' septal and lateral wall <9 cm/s). Biomarker criteria: BNP >100ng/L or NT-pro-BNP>400ng/L if sinus rhythm BNP >300ng/L or NT-pro-BNP>1200ng/L if atrial fibrillation Exclusion Criteria: Patients unwilling or unable to sign informed consent Patients with a pacemaker or ICD Indication for ICD therapy according to the ESC guidelines Life expectancy of less than one year Significant coronary artery disease or myocardial infarction < 3 months Complex congenital heart disease Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: ILR implantation|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of sustained ventricular tachyarrhythmias. | To study the incidence of ventricular tachyarrhythmias in patients with HFPEF at high-risk for arrhythmic mortality. | 2 years after ILR implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of atrial fibrillation (AF) in patients without baseline or history of AF |  | 2 years after ILR implantation | 
| The rate of progression of AF in patients without baseline or history of AF |  | 2 years after ILR implantation | 
| The incidence of HF hospitalizations, all cause mortality, cardiovascular mortality, and sudden cardiac death |  | 2 years after ILR implantation | 
| The incidence of non-sustained ventricular tachyarrhythmias |  | 2 years after ILR implantation | 
| Biomarkers (including ECG, Holter, echocardiography, CMR and blood biomarkers) for incident AF, and progression of AF in patients without baseline or history of AF |  | 2 years after ILR | 
| Biomarkers (including ECG, Holter, echocardiography, CMR and blood biomarkers) of sustained ventricular tachyarrhythmias |  | 2 years after ILR implantation | 
| Biomarkers (including ECG, Holter, echocardiography, CMR and blood biomarkers) of non-sustained ventricular tachyarrhythmias |  | 2 years after ILR implantation | 
| Biomarkers (including echocardiography, ECG and other arrhythmogenic markers and blood biomarkers) for development of HF hospitalizations, sudden death, arrhythmic death, and all-cause mortality |  | 2 years after ILR implantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ILR, Heart failure with preserved ejection fraction (HFpEF), ventricular tachyarrhythmias, Safety