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

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure With Preserved Ejection Fraction (HFpEF)
• Intervention / Treatment: Device: ILR implantation

• Study Type: Observational
• Enrollment (Actual): 113

Contacts and Locations

Study Locations

• Netherlands
  • Enschede, Netherlands
    • Medisch Spectrum Twente
  • Groningen, Netherlands
    • University Medical Center Groningen
  • Maastricht, Netherlands
    • Maastricht University Medical Center
  • Rotterdam, Netherlands, 3015 CE
    • Erasmus Medical Center
  • Tilburg, Netherlands, 5022 GC
    • Elisabeth-TweeSteden Ziekenhuis (ETZ)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with heart failure with preserved ejection fraction (HFpEF)

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Collaborators: Abbott Medical Devices
• Investigators: Principal Investigator: Michiel Rienstra, 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

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2014
• Primary Completion (ACTUAL): December 1, 2019
• Study Completion (ACTUAL): June 1, 2020

Study Registration Dates

• First Submitted: November 14, 2013
• First Submitted That Met QC Criteria: November 19, 2013
• First Posted (ESTIMATE): November 20, 2013

Study Record Updates

• Last Update Posted (ACTUAL): May 23, 2022
• Last Update Submitted That Met QC Criteria: May 19, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Safety; Heart failure with preserved ejection fraction (HFpEF); ILR; ventricular tachyarrhythmias
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Heart Failure; Tachycardia; Tachycardia, Ventricular
• Other Study ID Numbers: VIP-HF Registry