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

NCT01989299 | Completed DMC

• 1 other identifier: VIP-HF Registry
• Study Type: observational
• Target: 113
• Locations: 1 country
• Sites: 5

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.

Conditions

Heart Failure With Preserved Ejection Fraction (HFpEF)

Keywords

Heart failure with preserved ejection fraction (HFpEF); ILR; ventricular tachyarrhythmias; Safety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

Interventions

ILR implantation DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with heart failure with preserved ejection fraction (HFpEF)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Abbott Medical Devices: collaborator

Study Sites (5)

Medisch Spectrum Twente

Enschede, Netherlands

Location

University Medical Center Groningen

Groningen, Netherlands

Location

Maastricht University Medical Center

Maastricht, Netherlands

Location

Erasmus Medical Center

Rotterdam, 3015 CE, Netherlands

Location

Elisabeth-TweeSteden Ziekenhuis (ETZ)

Tilburg, 5022 GC, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 34935412 DERIVED

• 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.

  PMID: 32683763 DERIVED

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michiel Rienstra, MD, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

• Isabelle C van Gelder, 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr.

Study Record Dates

• First Submitted: November 14, 2013
• First Posted: November 20, 2013
• Study Start: November 1, 2014
• Primary Completion: December 1, 2019
• Study Completion: June 1, 2020
• Last Updated: May 23, 2022

Record last verified: 2022-05

Locations

NL (5)