Clinical trial NCT01989299: Ventricular Tachyarrhythmia Detection by Implantable Loop Recording in Patients With Heart Failure and Preserved Ejection Fraction
Official title: Ventricular Tachyarrhythmia Detection by Implantable Loop Recording in Patients With Heart Failure and Preserved Ejection Fraction (VIP-HF)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure With Preserved Ejection Fraction (HFpEF)
Keywords: Heart failure with preserved ejection fraction (HFpEF)
ILR
ventricular tachyarrhythmias
Safety
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: Abbott Medical Devices
First posted: 2013-11-20
Enrollment: 113
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 with heart failure with preserved ejection fraction (HFpEF)

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.


Eligibility criteria: 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

Primary outcomes:
measure: The incidence of sustained ventricular tachyarrhythmias.
timeFrame: 2 years after ILR implantation
Secondary outcomes:
measure: The incidence of atrial fibrillation (AF) in patients without baseline or history of AF
timeFrame: 2 years after ILR implantation
measure: The rate of progression of AF in patients without baseline or history of AF
timeFrame: 2 years after ILR implantation
measure: The incidence of HF hospitalizations, all cause mortality, cardiovascular mortality, and sudden cardiac death
timeFrame: 2 years after ILR implantation
measure: The incidence of non-sustained ventricular tachyarrhythmias
timeFrame: 2 years after ILR implantation
measure: Biomarkers (including ECG, Holter, echocardiography, CMR and blood biomarkers) for incident AF, and progression of AF in patients without baseline or history of AF
timeFrame: 2 years after ILR
measure: Biomarkers (including ECG, Holter, echocardiography, CMR and blood biomarkers) of sustained ventricular tachyarrhythmias
timeFrame: 2 years after ILR implantation
measure: Biomarkers (including ECG, Holter, echocardiography, CMR and blood biomarkers) of non-sustained ventricular tachyarrhythmias
timeFrame: 2 years after ILR implantation
measure: Biomarkers (including echocardiography, ECG and other arrhythmogenic markers and blood biomarkers) for development of HF hospitalizations, sudden death, arrhythmic death, and all-cause mortality
timeFrame: 2 years after ILR implantation
Other outcomes:
Locations:
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Tilburg
country: Netherlands
facility: Elisabeth-TweeSteden Ziekenhuis (ETZ)
Study officials:
affiliation: University Medical Center Groningen
name: Michiel Rienstra, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Center Groningen
name: Isabelle C van Gelder, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Center Groningen
name: Alexander H Maass, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Center Groningen
name: Dirk J Veldhuisen, van, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.