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

Heart Failure With Preserved Ejection Fraction (HFpEF) Clinical Trial

— VIP-HF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01989299
• Other study ID #: VIP-HF Registry
• Status: Completed
• Start date: November 2014
• Est. completion date: June 2020

Study information

• Verified date: May 2022
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: June 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Preserved Ejection Fraction (HFpEF)
• Tachycardia
• Tachycardia, Ventricular

Intervention

Device:
• ILR implantation

Locations

Country	Name	City	State
Netherlands	Medisch Spectrum Twente	Enschede
Netherlands	University Medical Center Groningen	Groningen
Netherlands	Maastricht University Medical Center	Maastricht
Netherlands	Erasmus Medical Center	Rotterdam
Netherlands	Elisabeth-TweeSteden Ziekenhuis (ETZ)	Tilburg

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Center Groningen	Abbott Medical Devices

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The incidence of atrial fibrillation (AF) in patients without baseline or history of AF		2 years after ILR implantation
Secondary	The rate of progression of AF in patients without baseline or history of AF		2 years after ILR implantation
Secondary	The incidence of HF hospitalizations, all cause mortality, cardiovascular mortality, and sudden cardiac death		2 years after ILR implantation
Secondary	The incidence of non-sustained ventricular tachyarrhythmias		2 years after ILR implantation
Secondary	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
Secondary	Biomarkers (including ECG, Holter, echocardiography, CMR and blood biomarkers) of sustained ventricular tachyarrhythmias		2 years after ILR implantation
Secondary	Biomarkers (including ECG, Holter, echocardiography, CMR and blood biomarkers) of non-sustained ventricular tachyarrhythmias		2 years after ILR implantation
Secondary	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