Heart Failure With Preserved Ejection Fraction (HFpEF)
Conditions
Keywords
Heart failure with preserved ejection fraction (HFpEF), ILR, ventricular tachyarrhythmias, Safety
Brief summary
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.
Interventions
DEVICEILR implantation
Sponsors
Abbott Medical Devices
University Medical Center Groningen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Clinical criteria: 1. Age \>18 years 2. Written informed consent 3. HF with moderate to severe symptoms NYHA II or III 4. Hospitalization or emergency room visit for HF or symptom relief with diuretics within 12 months 5. Sinus rhythm or AF Echocardiographic criteria: 1. LVEF \>40% 2. 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: 1. BNP \>100ng/L or NT-pro-BNP\>400ng/L if sinus rhythm 2. BNP \>300ng/L or NT-pro-BNP\>1200ng/L if atrial fibrillation
Exclusion criteria
1. Patients unwilling or unable to sign informed consent 2. Patients with a pacemaker or ICD 3. Indication for ICD therapy according to the ESC guidelines 4. Life expectancy of less than one year 5. Significant coronary artery disease or myocardial infarction \< 3 months 6. Complex congenital heart disease 7. Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of sustained ventricular tachyarrhythmias. | 2 years after ILR implantation | To study the incidence of ventricular tachyarrhythmias in patients with HFPEF at high-risk for arrhythmic mortality. |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| The incidence of atrial fibrillation (AF) in patients without baseline or history of AF | 2 years after ILR implantation |
| 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 |
| 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 |
Countries
Netherlands
Outcome results
None listed