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

Sponsor
University Medical Center Groningen (Other)
Overall Status
Completed
CT.gov ID
NCT01989299
Collaborator
Abbott Medical Devices (Industry)
113
Enrollment
5
Locations
67
Actual Duration (Months)
22.6
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: ILR implantation

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
113 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Ventricular Tachyarrhythmia Detection by Implantable Loop Recording in Patients With Heart Failure and Preserved Ejection Fraction (VIP-HF)
Actual Study Start Date :
Nov 1, 2014
Actual Primary Completion Date :
Dec 1, 2019
Actual Study Completion Date :
Jun 1, 2020

Outcome Measures

Primary Outcome Measures

  1. 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

  1. The incidence of atrial fibrillation (AF) in patients without baseline or history of AF [2 years after ILR implantation]

  2. The rate of progression of AF in patients without baseline or history of AF [2 years after ILR implantation]

  3. The incidence of HF hospitalizations, all cause mortality, cardiovascular mortality, and sudden cardiac death [2 years after ILR implantation]

  4. The incidence of non-sustained ventricular tachyarrhythmias [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 [2 years after ILR]

  6. Biomarkers (including ECG, Holter, echocardiography, CMR and blood biomarkers) of sustained ventricular tachyarrhythmias [2 years after ILR implantation]

  7. Biomarkers (including ECG, Holter, echocardiography, CMR and blood biomarkers) of non-sustained ventricular tachyarrhythmias [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 [2 years after ILR implantation]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medisch Spectrum Twente Enschede Netherlands
2 University Medical Center Groningen Groningen Netherlands
3 Maastricht University Medical Center Maastricht Netherlands
4 Erasmus Medical Center Rotterdam Netherlands 3015 CE
5 Elisabeth-TweeSteden Ziekenhuis (ETZ) Tilburg Netherlands 5022 GC

Sponsors and Collaborators

  • University Medical Center Groningen
  • Abbott Medical Devices

Investigators

  • Principal Investigator: 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
M. Rienstra, dr., University Medical Center Groningen
ClinicalTrials.gov Identifier:
NCT01989299
Other Study ID Numbers:
  • VIP-HF Registry
First Posted:
Nov 20, 2013
Last Update Posted:
May 23, 2022
Last Verified:
May 1, 2022
Keywords provided by M. Rienstra, dr., University Medical Center Groningen
Heart failure with preserved ejection fraction (HFpEF)
ILR
ventricular tachyarrhythmias
Safety
Additional relevant MeSH terms:
Heart Failure
Tachycardia
Tachycardia, Ventricular

Study Results

No Results Posted as of May 23, 2022