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| Name | Class |
|---|---|
| Abbott Medical Devices | INDUSTRY |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ILR implantation | Device |
| 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 |
| 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 |
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Inclusion Criteria:
Clinical criteria:
Echocardiographic criteria:
Biomarker criteria:
Exclusion Criteria:
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Patients with heart failure with preserved ejection fraction (HFpEF)
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| Name | Affiliation | Role |
|---|---|---|
| Michiel Rienstra, MD, PhD | University Medical Center Groningen | Principal Investigator |
| Isabelle C van Gelder, MD, PhD | University Medical Center Groningen | Principal Investigator |
| Alexander H Maass, MD, PhD | University Medical Center Groningen | Principal Investigator |
| Dirk J Veldhuisen, van, MD, PhD | University Medical Center Groningen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medisch Spectrum Twente | Enschede | Netherlands | ||||
| University Medical Center Groningen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34935412 | Derived | van Woerden G, van Veldhuisen DJ, Manintveld OC, van Empel VPM, Willems TP, de Boer RA, Rienstra M, Westenbrink BD, Gorter TM. Epicardial Adipose Tissue and Outcome in Heart Failure With Mid-Range and Preserved Ejection Fraction. Circ Heart Fail. 2022 Mar;15(3):e009238. doi: 10.1161/CIRCHEARTFAILURE.121.009238. Epub 2021 Dec 22. | |
| 32683763 |
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| 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 |
| Groningen |
| Netherlands |
| Maastricht University Medical Center | Maastricht | Netherlands |
| Erasmus Medical Center | Rotterdam | 3015 CE | Netherlands |
| Elisabeth-TweeSteden Ziekenhuis (ETZ) | Tilburg | 5022 GC | Netherlands |
| van Veldhuisen DJ, van Woerden G, Gorter TM, van Empel VPM, Manintveld OC, Tieleman RG, Maass AH, Vernooy K, Westenbrink BD, van Gelder IC, Rienstra M. Ventricular tachyarrhythmia detection by implantable loop recording in patients with heart failure and preserved ejection fraction: the VIP-HF study. Eur J Heart Fail. 2020 Oct;22(10):1923-1929. doi: 10.1002/ejhf.1970. Epub 2020 Aug 21. |
| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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