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CompletedNCT03447002Updated Nov 14, 2019

Urine Levels of Metanephrin and Normetanephrin in Patients With Frequent Ventricular Premature Complex

An observational study in Premature Ventricular Contraction, sponsored by TC Erciyes University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-11-14.

Sponsored by TC Erciyes University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 90 Years
Sex
All
01

Study summary

Enhanced automaticity process is the underlying mechanism for arrhythmias due to excess catecholamines. Catecholamines may increase in patients with PVC. Metabolites of catecholamines are metanephrine and normetanephrine. Our aim is to measure 24 hours urine levels of metanephrine and normetanephrine.

Read the detailed description

Premature ventricular complex is a very frequent arrhythmia. Suggested mechanisms for PVCs are reentry, triggered activity, and enhanced automaticity. Enhanced automaticity process is the underlying mechanism for arrhythmias due to excess catecholamines. Catecholamines may increase in patients with PVC. Half-lives of catecholamines are very short and rather changeable. Therefore, 24 hours urine levels of catecholamines are the more sensitive than plasma levels. Metabolites of catecholamines are metanephrine and normetanephrine. Our aim is to measure 24 hours urine levels of metanephrine and normetanephrine.

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Conditions studied

  • Premature Ventricular Contraction

Keywords

  • premature
  • pvc
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In context

Ventricular Premature Complexes

102 studies on the registry are indexed under Ventricular Premature Complexes; 32 are open to participants now.

This study's enrollment of 100 is below the median of 125 across 39 observational studies indexed under Ventricular Premature Complexes.

Browse Ventricular Premature Complexes studies →

Lead sponsor

TC Erciyes University is the lead sponsor of 349 studies on the registry; 74 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

patients with % 5 or higher frequents premature ventricular complex in 24 hours rhythm recording will be taken our study.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • PVC's rate is more than % 5 in 24 hours rhythm recording

Exclusion criteria

Exclusion Criteria:

  • ischemic heart disease
  • hyperthyroidism
  • patients with low
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No

Interventions

  • Diagnostic test24 hours urine levels metanephrine and normetanephrine

    24 hours rhythm recording and 24 hours urine measurement

    Also known as: rhythm recording

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What researchers measure

Primary outcomes

  1. metanephrine and normetanephrine levels

    metanephrine and normetanephrine levels asociated premature ventricular complex frequents

    Time frame: about 10 months

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Study locations

1 site
  • Erciyes university Yilmaz- mehmet öztaşkın heart hospital
    Kayseri, Turkey
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References and documents

Publications

  • Im SI, Park KM, Park SJ, Kim JS, On YK. New electrocardiographic criteria for predicting successful ablation of premature ventricular contractions from the right coronary cusp. Int J Cardiol. 2016 Dec 1;224:199-205. doi: 10.1016/j.ijcard.2016.09.029. Epub 2016 Sep 16. PubMed 27657474 ↗
  • Bradfield JS, Homsi M, Shivkumar K, Miller JM. Coupling interval variability differentiates ventricular ectopic complexes arising in the aortic sinus of valsalva and great cardiac vein from other sources: mechanistic and arrhythmic risk implications. J Am Coll Cardiol. 2014 May 27;63(20):2151-2158. doi: 10.1016/j.jacc.2014.02.551. Epub 2014 Mar 19. PubMed 24657687 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2018 to primary completion in Sep 2019, 19 months.

Of 23 observational studies under Ventricular Premature Complexes, half reached primary completion within 51 months of starting (the median), counting those still running; a quarter within 28. This study's 19 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 19, 2018
First posted
Feb 27, 2018
StartActual
Feb 15, 2018
Primary completionActual
Sep 30, 2019
CompletionActual
Sep 30, 2019
Last update
Nov 14, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 14, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03447002
Responsible party
Burak Cesur (burak cesur, TC Erciyes University) — Principal investigator
First posted
Feb 27, 2018
Start date
Feb 15, 2018
Primary completion
Sep 30, 2019
Completion
Sep 30, 2019
Last update
Nov 14, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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