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

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ClinicalTrials.gov Identifier: NCT01989299
Recruitment Status : Enrolling by invitation
First Posted : November 20, 2013
Last Update Posted : September 25, 2019
Sponsor:
Collaborator:
Abbott Medical Devices
Information provided by (Responsible Party):
M. Rienstra, 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.

Condition or disease Intervention/treatment
Heart Failure With Preserved Ejection Fraction (HFpEF) Device: ILR implantation

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Ventricular Tachyarrhythmia Detection by Implantable Loop Recording in Patients With Heart Failure and Preserved Ejection Fraction (VIP-HF)
Actual Study Start Date : November 2014
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with heart failure with preserved ejection fraction (HFpEF)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01989299


Locations
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Netherlands
Medisch Spectrum Twente
Enschede, Netherlands
University Medical Center Groningen
Groningen, Netherlands
Maastricht University Medical Center
Maastricht, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands, 3015 CE
Elisabeth-TweeSteden Ziekenhuis (ETZ)
Tilburg, Netherlands, 5022 GC
Sponsors and Collaborators
University Medical Center Groningen
Abbott Medical Devices
Investigators
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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

Additional Information:

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Responsible Party: M. Rienstra, dr., University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT01989299     History of Changes
Other Study ID Numbers: VIP-HF Registry
First Posted: November 20, 2013    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Keywords provided by M. Rienstra, University Medical Center Groningen:
Heart failure with preserved ejection fraction (HFpEF)
ILR
ventricular tachyarrhythmias
Safety
Additional relevant MeSH terms:
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Heart Failure
Tachycardia
Tachycardia, Ventricular
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Cardiac Conduction System Disease
Pathologic Processes