Premature Ventricular ContractionNCT03447002
Urine Levels of Metanephrin and Normetanephrin in Patients With Frequent Ventricular Premature Complex
An observational study of Premature Ventricular Contraction, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial 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 more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Premature Ventricular Contraction
- What is being tested?
- 24 hours urine levels metanephrine and normetanephrine
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2018to 30 Sep 2019
- 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 to 90 years
- All sexes
- Adult, Older adult
Study population: patients with % 5 or higher frequents premature ventricular complex in 24 hours rhythm recording will be taken our study.
Who may be able to join
- PVC's rate is more than % 5 in 24 hours rhythm recording
Who cannot join
- ischemic heart disease
- hyperthyroidism
- patients with low ejection fraction
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erciyes university Yilmaz- mehmet öztaşkın heart hospital
Kayseri
About this study
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.
- Conditions
- Premature Ventricular Contraction
- Being tested
- 24 hours urine levels metanephrine and normetanephrine
- Keywords
- premature, pvc
- Medical subject headings
- Ventricular Premature Complexes, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24 hours urine levels metanephrine and normetanephrineDiagnostic test
Also called rhythm recording
24 hours rhythm recording and 24 hours urine measurement
What is being measured
The primary outcome is the main question the study is designed to answer.
metanephrine and normetanephrine levels
metanephrine and normetanephrine levels asociated premature ventricular complex frequents
Measured: about 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start15 Feb 2018
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Premature Ventricular ContractionStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burak Cesur, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03447002
- Sponsor's protocol ID
- ErciyesU
- Status last verified
- Nov 2019
- First submitted
- 19 Feb 2018
- Last updated
- 14 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 27657474Bradfield 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 24657687Cesur 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.
PubMed 38035655
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urine Levels of Metanephrin and Normetanephrin in Patients With Frequent Ventricular Premature Complex
- ClinicalTrials.gov ID
- NCT03447002
- Acronym / sponsor ID
- ErciyesU
- Conditions
- Premature Ventricular Contraction
- Keywords
- premature, pvc
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 15 Feb 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 27 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients with % 5 or higher frequents premature ventricular complex in 24 hours rhythm recording will be taken our study.
Key inclusion criteria (1 listed)
- PVC's rate is more than % 5 in 24 hours rhythm recording
Key exclusion criteria (3 listed)
- ischemic heart disease
- hyperthyroidism
- patients with low ejection fraction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 24 hours urine levels metanephrine and normetanephrineAlso: rhythm recording24 hours rhythm recording and 24 hours urine measurement | Diagnostic test | – |
Primary outcome
metanephrine and normetanephrine levels
Time frame: about 10 months
metanephrine and normetanephrine levels asociated premature ventricular complex frequents
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2019.
- Background: PubMed 27657474Im 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.
- Background: PubMed 24657687Bradfield 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.
- Derived from this study: PubMed 38035655Cesur 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Ventricular Contraction, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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 1 inclusion and 3 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 14 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
metanephrine and normetanephrine levels (time frame: about 10 months). 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 NCT03447002, which also lists 3 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 14 Nov 2019.