NCT03447002

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2018

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 19, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 27, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

November 14, 2019

Status Verified

November 1, 2019

Enrollment Period

1.6 years

First QC Date

February 19, 2018

Last Update Submit

November 12, 2019

Conditions

Keywords

prematurepvc

Outcome Measures

Primary Outcomes (1)

  • metanephrine and normetanephrine levels

    metanephrine and normetanephrine levels asociated premature ventricular complex frequents

    about 10 months

Interventions

24 hours rhythm recording and 24 hours urine measurement

Also known as: rhythm recording

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • ischemic heart disease
  • hyperthyroidism
  • patients with low ejection fraction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes university Yilmaz- mehmet öztaşkın heart hospital

Kayseri, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 27657474BACKGROUND
  • 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.

    PMID: 24657687BACKGROUND
  • Cesur B, Elcik D, Cetinkaya Z, Kelesoglu S, Karabiyik U, Inanc MT, Kalay N, Ergin A, Topsakal R. Association between excess catecholamine synthesis and polymorphic premature ventricular contraction. J Electrocardiol. 2024 Jan-Feb;82:59-63. doi: 10.1016/j.jelectrocard.2023.11.010. Epub 2023 Nov 26.

MeSH Terms

Conditions

Ventricular Premature ComplexesPremature Birth

Condition Hierarchy (Ancestors)

Cardiac Complexes, PrematureArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and SymptomsObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
burak cesur

Study Record Dates

First Submitted

February 19, 2018

First Posted

February 27, 2018

Study Start

February 15, 2018

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

November 14, 2019

Record last verified: 2019-11

Locations