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

Completed

• Conditions: Heart Failure With Preserved Ejection Fraction (HFpEF)

• Registration Number: NCT01989299
• Lead Sponsor: University Medical Center Groningen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-14
• Study First Submitted QC: 2013-11-19
• Study First Posted: 2013-11-20
• Study Start: 2014-11
• Primary Completion: 2019-12
• Study Completion: 2020-06
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-19
• Last Update Posted: 2022-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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
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 non-sustained ventricular tachyarrhythmias	2 years after ILR implantation

Trial Locations

Locations (5)

Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands

Medisch Spectrum Twente; 🇳🇱 Enschede, Netherlands

Elisabeth-TweeSteden Ziekenhuis (ETZ); 🇳🇱 Tilburg, Netherlands

Maastricht University Medical Center; 🇳🇱 Maastricht, Netherlands