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OpenTrials
Completed

NCT Number: NCT01989299

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

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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Key information

Conditions

Heart Failure With Preserved Ejection Fraction (HFpEF) Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Ventricular

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medisch Spectrum Twente, Enschede, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Clinical criteria:

  • Age >18 years
  • Written informed consent
  • HF with moderate to severe symptoms NYHA II or III
  • Hospitalization or emergency room visit for HF or symptom relief with diuretics within 12 months
  • Sinus rhythm or AF

Echocardiographic criteria:

  • LVEF >40%
  • 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:

  • BNP >100ng/L or NT-pro-BNP>400ng/L if sinus rhythm
  • BNP >300ng/L or NT-pro-BNP>1200ng/L if atrial fibrillation

Exclusion criteria

  • Patients unwilling or unable to sign informed consent
  • Patients with a pacemaker or ICD
  • Indication for ICD therapy according to the ESC guidelines
  • Life expectancy of less than one year
  • Significant coronary artery disease or myocardial infarction < 3 months
  • Complex congenital heart disease
  • Pregnancy

Treatment and study plan

ILR implantation

Device

Primary outcomes

  1. The incidence of sustained ventricular tachyarrhythmias.

    Time frame: 2 years after ILR implantation

    To study the incidence of ventricular tachyarrhythmias in patients with HFPEF at high-risk for arrhythmic mortality.

Secondary outcomes

  1. The incidence of atrial fibrillation (AF) in patients without baseline or history of AF

    Time frame: 2 years after ILR implantation

  2. The rate of progression of AF in patients without baseline or history of AF

    Time frame: 2 years after ILR implantation

  3. The incidence of HF hospitalizations, all cause mortality, cardiovascular mortality, and sudden cardiac death

    Time frame: 2 years after ILR implantation

  4. The incidence of non-sustained ventricular tachyarrhythmias

    Time frame: 2 years after ILR implantation

  5. Biomarkers (including ECG, Holter, echocardiography, CMR and blood biomarkers) for incident AF, and progression of AF in patients without baseline or history of AF

    Time frame: 2 years after ILR

  6. Biomarkers (including ECG, Holter, echocardiography, CMR and blood biomarkers) of sustained ventricular tachyarrhythmias

    Time frame: 2 years after ILR implantation

  7. Biomarkers (including ECG, Holter, echocardiography, CMR and blood biomarkers) of non-sustained ventricular tachyarrhythmias

    Time frame: 2 years after ILR implantation

  8. Biomarkers (including echocardiography, ECG and other arrhythmogenic markers and blood biomarkers) for development of HF hospitalizations, sudden death, arrhythmic death, and all-cause mortality

    Time frame: 2 years after ILR implantation

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Collaborators

  • Abbott Medical Devices

Registry information

Official study title

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

Acronym: VIP-HF

Important dates

Study start
2014
Primary completion
2019
Study completion
2020
First posted
Nov 20, 2013
Registry last updated
May 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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