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Heart Failure With Preserved Ejection Fraction (HFpEF)VIP-HFNCT01989299

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

An observational study of Heart Failure With Preserved Ejection Fraction (HFpEF), run by University Medical Center Groningen at 5 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ILR implantation
Type of treatment
Medical device
How many people
113 participants
Where
5 sitesNetherlands
Study dates
Nov 2014to Jun 2020
How long will I take part?
2 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with heart failure with preserved ejection fraction (HFpEF)

Who may be able to join

  • 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
Show all 12Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Netherlands5 sites

  • Medisch Spectrum Twente

    Enschede

  • University Medical Center Groningen

    Groningen

  • Maastricht University Medical Center

    Maastricht

  • Erasmus Medical Center

    Rotterdam, 3015 CE

  • Elisabeth-TweeSteden Ziekenhuis (ETZ)

    Tilburg, 5022 GC

Other trials in Netherlands

About this study

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

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.

Being tested
ILR implantation
Keywords
Heart failure with preserved ejection fraction (HFpEF), ILR, ventricular tachyarrhythmias, Safety
Medical subject headings
Tachycardia, Ventricular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ILR implantationDevice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The incidence of sustained ventricular tachyarrhythmias.

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

    Measured: 2 years after ILR implantation

Secondary outcomes (8)

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

    Measured: 2 years after ILR implantation

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

    Measured: 2 years after ILR implantation

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

    Measured: 2 years after ILR implantation

  4. The incidence of non-sustained ventricular tachyarrhythmias

    Measured: 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

    Measured: 2 years after ILR

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

    Measured: 2 years after ILR implantation

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

    Measured: 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

    Measured: 2 years after ILR implantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2013 (estimated)
  2. Study startNov 2014
  3. Primary completionDec 2019
  4. Study completionJun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
113 participants (actual)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT01989299
Sponsor's protocol ID
VIP-HF Registry
Acronym
VIP-HF
Status last verified
May 2022
First submitted
14 Nov 2013
Last updated
23 May 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 34935412

  • 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.

    PubMed 32683763

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure With Preserved Ejection Fraction (HFpEF), run by University Medical Center Groningen at 5 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of sustained ventricular tachyarrhythmias. (time frame: 2 years after ILR implantation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01989299, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2022.

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