Premature Ventricular ComplexesPVTNCT07870109
Premature Ventricular Complex and Diet Inflamatuar Index
An observational study of Premature Ventricular Complexes and Diet Quality, run by Izmir Democracy University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate differences in energy, macro- and micronutrient intakes, dietary characteristics, quality of life, and biochemical parameters between individuals with and without premature ventricular complexes. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Premature Ventricular Complexes, Diet Quality, Biochemical Markers
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2026to 15 Nov 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will include 50 individuals with premature ventricular complexes (PVCs) and 50 healthy adults who present to the Cardiology Outpatient Clinic of Buca Seyfi Demirsoy Training and Research Hospital. Participants will be asked to discontinue caffeine-containing beverages, stimulants, and medications that may affect cardiac rhythm for 72 hours prior to Holter monitoring. The diagnosis of premature ventricular complexes will be established by a specialist cardiologist.
Who may be able to join
- Inclusion criteria for individuals with premature ventricular complexes (PVCs):
- Being between 18 and 80 years of age.
- Having >10,000 PVCs/day, as determined by 24-hour Holter monitoring.
- Being between 18 and 80 years of age.
- Having <10,000 PVCs/day, as determined by 24-hour Holter monitoring.
Who cannot join
- Exclusion criteria for individuals with premature ventricular complexes (PVC):
- Having an active infection,
- Having tachycardia due to secondary causes,
- Having congestive heart failure (including PVC-induced tachycardiomyopathy),
- Having symptomatic congenital heart disease,
- Having symptomatic valvular heart disease,
Show all 18Show fewer
- Having diagnosed coronary artery disease,
- Having a diagnosed psychiatric disorder,
- Having an eating disorder such as anorexia nervosa or bulimia nervosa.
- Being <18 or >80 years of age,
- Having an active infection,
- Having tachycardia due to secondary causes,
- Having congestive heart failure (including PVC-induced tachycardiomyopathy),
- Having symptomatic congenital heart disease,
- Having symptomatic valvular heart disease,
- Having diagnosed coronary artery disease,
- Having a diagnosed psychiatric disorder,
- Having an eating disorder such as anorexia nervosa or bulimia nervosa.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Buca Seyfi Demirsoy Training and Research Hospital
Izmir, 35310
Erkan ALPASLAN, PhD, 05057908262, erkan8721@gmail.com
About this study
Official title: Comparison of Dietary Inflammatory Index, Quality of Life, and Biochemical Parameters Between Individuals With and Without Premature Ventricular Complexes
The aim of this study is to evaluate differences in energy, macro- and micronutrient intakes, dietary characteristics, quality of life, and biochemical parameters between individuals with and without premature ventricular complexes. The study will include a total of 100 adults who present to the Cardiology Outpatient Clinic of Buca Seyfi Demirsoy Training and Research Hospital, comprising 50 individuals with premature ventricular complexes and 50 healthy individuals. Participants will be instructed to discontinue caffeine-containing beverages, stimulants, and medications that may affect cardiac rhythm for 72 hours prior to Holter monitoring. The diagnosis of premature ventricular complexes will be established by a specialist cardiologist. Dietary intake will be assessed using three non-consecutive 24-hour dietary recalls, including two weekdays and one weekend day. Dietary intake data will be collected by the researcher through face-to-face interviews and recorded on the study questionnaire. The Dietary Inflammatory Index (DII) and Healthy Eating Index will be calculated based on the participants' three-day dietary intake data. No additional blood samples or biochemical tests will be requested specifically for the purposes of this study. Instead, the participants' most recent biochemical parameters obtained as part of routine clinical care will be retrieved from their medical records. These parameters will include fasting blood glucose (mg/dL), glycated hemoglobin (HbA1c, %), total cholesterol (mg/dL), high-density lipoprotein cholesterol (HDL-C, mg/dL), low-density lipoprotein cholesterol (LDL-C, mg/dL), triglycerides (mg/dL), vitamin D, and other routinely assessed biochemical parameters. The results will be interpreted according to the reference ranges used by Buca Seyfi Demirsoy Training and Research Hospital. Participants' quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36).
Read the detailed description
Although premature ventricular contractions are among the most common types of arrhythmia in patients both with and without structural heart disease, they may lead to long-term left ventricular dysfunction in patients with structurally normal hearts. An increased frequency of premature ventricular complexes (PVCs) may be associated with mental and physical stress, lifestyle-related factors, as well as cardiovascular risk factors such as hypertension, dyslipidemia, diabetes mellitus, and coronary artery disease. Frequent PVCs may lead to tachycardiomyopathy and, consequently, increased morbidity and mortality. The aim of this study is to evaluate differences in energy, macro- and micronutrient intakes, dietary characteristics, quality of life, and biochemical parameters between individuals with and without premature ventricular complexes. The study will include a total of 100 adults who present to the Cardiology Outpatient Clinic of Buca Seyfi Demirsoy Training and Research Hospital, comprising 50 individuals with premature ventricular complexes and 50 healthy individuals. Participants will be instructed to discontinue caffeine-containing beverages, stimulants, and medications that may affect cardiac rhythm for 72 hours prior to Holter monitoring. The diagnosis of premature ventricular complexes will be established by a specialist cardiologist. Dietary intake will be assessed using three non-consecutive 24-hour dietary recalls, including two weekdays and one weekend day. Dietary intake data will be collected by the researcher through face-to-face interviews and recorded on the study questionnaire. The Dietary Inflammatory Index (DII) and Healthy Eating Index will be calculated based on the participants' three-day dietary intake data. No additional blood samples or biochemical tests will be requested specifically for the purposes of this study. Instead, the participants' most recent biochemical parameters obtained as part of routine clinical care will be retrieved from their medical records. These parameters will include fasting blood glucose (mg/dL), glycated hemoglobin (HbA1c, %), total cholesterol (mg/dL), high-density lipoprotein cholesterol (HDL-C, mg/dL), low-density lipoprotein cholesterol (LDL-C, mg/dL), triglycerides (mg/dL), vitamin D, and other routinely assessed biochemical parameters. The results will be interpreted according to the reference ranges used by Buca Seyfi Demirsoy Training and Research Hospital. Participants' quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36).
- Keywords
- Premature Ventricular Complex, Diet Inflammatory Index, Life Quality, Blood Parameters
- Medical subject headings
- Ventricular Premature Complexes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients of Premature Ventricular Complex | The study will include 50 individuals with premature ventricular complexes who present to the Cardiology Outpatient Clinic of Buca Seyfi Demirsoy Training and Research Hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diet Inflammatory Index
The Dietary Inflammatory Index will be calculated for patients with premature ventricular complexes
Measured: From enrollment to the end of treatment at 2 years
Secondary outcomes (10)
Diet Quality
Diet quality will be assessed using the Diet Quality Index-International (DQI-I) scoring system
Measured: From enrollment to the end of treatment at 2 years
Food Variety
Participants' dietary variety will be determined using 3-day dietary records
Measured: From enrollment to the end of treatment at 2 years
Glucose
Serum glucose will be obtained from the participants' routine blood parameters.
Measured: From enrollment to the end of treatment at 2 years
Hemoglobin A1c
The data will be obtained from the participants' routine blood test results.
Measured: From enrollment to the end of treatment at 2 years
Total Cholesterol
The data will be obtained from the participants' routine blood test results.
Measured: From enrollment to the end of treatment at 2 years
High Density Lipoprotein
The data will be obtained from the participants' routine blood test results.
Measured: From enrollment to the end of treatment at 2 years
Low Density Lipoprotein
The data will be obtained from the participants' routine blood test results.
Measured: From enrollment to the end of treatment at 2 years
Trygliseride
The data will be obtained from the participants' routine blood test results.
Measured: From enrollment to the end of treatment at 2 years
Vitamin D
The data will be obtained from the participants' routine blood test results.
Measured: From enrollment to the end of treatment at 2 years
Life Quality
The Short Form-36 Health Survey will be used to assess the participants' quality of life.
Measured: From enrollment to the end of treatment at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start15 Nov 2026 (estimated)
- Primary completion15 Nov 2027 (estimated)
- Study completion15 Nov 2027 (estimated)
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 ComplexesStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 100 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Izmir Democracy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerim Kaan Göküstün, Izmir Democracy University
- Investigators
- Kerim K GÖKÜSTÜN, PhD, Principal investigator, Izmir Democracy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07870109
- Sponsor's protocol ID
- Premature Ventricular Comp.
- Acronym
- PVT
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared to protect participant confidentiality and ensure compliance with data privacy requirements.
Publications
Shivappa N, Steck SE, Hurley TG, Hussey JR, Hebert JR. Designing and developing a literature-derived, population-based dietary inflammatory index. Public Health Nutr. 2014 Aug;17(8):1689-96. doi: 10.1017/S1368980013002115. Epub 2013 Aug 14.
PubMed 23941862Geelen A, Brouwer IA, Schouten EG, Maan AC, Katan MB, Zock PL. Effects of n-3 fatty acids from fish on premature ventricular complexes and heart rate in humans. Am J Clin Nutr. 2005 Feb;81(2):416-20. doi: 10.1093/ajcn.81.2.416.
PubMed 15699229Kuyumcu, M. S., & Kuyumcu, A. (2020). Mediterranean diet effects on ventricular premature complexes. Annals of Medical Research, 27(1), 79.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dietary Inflammatory Index, Quality of Life, and Biochemical Parameters Between Individuals With and Without Premature Ventricular Complexes
- ClinicalTrials.gov ID
- NCT07870109
- Acronym / sponsor ID
- PVT / Premature Ventricular Comp.
- Keywords
- Premature Ventricular Complex, Diet Inflammatory Index, Life Quality, Blood Parameters
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Izmir Democracy UniversityUniversity, hospital or other
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 15 Nov 2027 (estimated)
- Study completion
- 15 Nov 2027 (estimated)
- First posted
- 13 Oct 2026 (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.
The aim of this study is to evaluate differences in energy, macro- and micronutrient intakes, dietary characteristics, quality of life, and biochemical parameters between individuals with and without premature ventricular complexes. The study will include a total of 100 adults who present to the Cardiology Outpatient Clinic of Buca Seyfi Demirsoy Training and Research Hospital, comprising 50 individuals with premature ventricular complexes and 50 healthy individuals. Participants will be instructed to discontinue caffeine-containing beverages, stimulants, and medications that may affect cardiac rhythm for 72 hours prior to Holter monitoring. The diagnosis of premature ventricular complexes will be established by a specialist cardiologist. Dietary intake will be assessed using three non-consecutive 24-hour dietary recalls, including two weekdays and one weekend day. Dietary intake data will be collected by the researcher through face-to-face interviews and recorded on the study questionnaire. The Dietary Inflammatory Index (DII) and Healthy Eating Index will be calculated based on the participants' three-day dietary intake data. No additional blood samples or biochemical tests will be requested specifically for the purposes of this study. Instead, the participants' most recent biochemical parameters obtained as part of routine clinical care will be retrieved from their medical records. These parameters will include fasting blood glucose (mg/dL), glycated hemoglobin (HbA1c, %), total cholesterol (mg/dL), high-density lipoprotein cholesterol (HDL-C, mg/dL), low-density lipoprotein cholesterol (LDL-C, mg/dL), triglycerides (mg/dL), vitamin D, and other routinely assessed biochemical parameters. The results will be interpreted according to the reference ranges used by Buca Seyfi Demirsoy Training and Research Hospital. Participants' quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36).
Detailed description
Although premature ventricular contractions are among the most common types of arrhythmia in patients both with and without structural heart disease, they may lead to long-term left ventricular dysfunction in patients with structurally normal hearts. An increased frequency of premature ventricular complexes (PVCs) may be associated with mental and physical stress, lifestyle-related factors, as well as cardiovascular risk factors such as hypertension, dyslipidemia, diabetes mellitus, and coronary artery disease. Frequent PVCs may lead to tachycardiomyopathy and, consequently, increased morbidity and mortality. The aim of this study is to evaluate differences in energy, macro- and micronutrient intakes, dietary characteristics, quality of life, and biochemical parameters between individuals with and without premature ventricular complexes. The study will include a total of 100 adults who present to the Cardiology Outpatient Clinic of Buca Seyfi Demirsoy Training and Research Hospital, comprising 50 individuals with premature ventricular complexes and 50 healthy individuals. Participants will be instructed to discontinue caffeine-containing beverages, stimulants, and medications that may affect cardiac rhythm for 72 hours prior to Holter monitoring. The diagnosis of premature ventricular complexes will be established by a specialist cardiologist. Dietary intake will be assessed using three non-consecutive 24-hour dietary recalls, including two weekdays and one weekend day. Dietary intake data will be collected by the researcher through face-to-face interviews and recorded on the study questionnaire. The Dietary Inflammatory Index (DII) and Healthy Eating Index will be calculated based on the participants' three-day dietary intake data. No additional blood samples or biochemical tests will be requested specifically for the purposes of this study. Instead, the participants' most recent biochemical parameters obtained as part of routine clinical care will be retrieved from their medical records. These parameters will include fasting blood glucose (mg/dL), glycated hemoglobin (HbA1c, %), total cholesterol (mg/dL), high-density lipoprotein cholesterol (HDL-C, mg/dL), low-density lipoprotein cholesterol (LDL-C, mg/dL), triglycerides (mg/dL), vitamin D, and other routinely assessed biochemical parameters. The results will be interpreted according to the reference ranges used by Buca Seyfi Demirsoy Training and Research Hospital. Participants' quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients of Premature Ventricular Complex | – | –The study will include 50 individuals with premature ventricular complexes who present to the Cardiology Outpatient Clinic of Buca Seyfi Demirsoy Training and Research Hospital. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include 50 individuals with premature ventricular complexes (PVCs) and 50 healthy adults who present to the Cardiology Outpatient Clinic of Buca Seyfi Demirsoy Training and Research Hospital. Participants will be asked to discontinue caffeine-containing beverages, stimulants, and medications that may affect cardiac rhythm for 72 hours prior to Holter monitoring. The diagnosis of premature ventricular complexes will be established by a specialist cardiologist.
Key inclusion criteria (5 listed)
- Being between 18 and 80 years of age.
- Having >10,000 PVCs/day, as determined by 24-hour Holter monitoring.
- Being between 18 and 80 years of age.
- Having <10,000 PVCs/day, as determined by 24-hour Holter monitoring.
Key exclusion criteria (18 listed)
- Having an active infection,
- Having tachycardia due to secondary causes,
- Having congestive heart failure (including PVC-induced tachycardiomyopathy),
- Having symptomatic congenital heart disease,
- Having symptomatic valvular heart disease,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diet Inflammatory Index
Time frame: From enrollment to the end of treatment at 2 years
The Dietary Inflammatory Index will be calculated for patients with premature ventricular complexes
10 secondary outcomes
Diet Quality
Time frame: From enrollment to the end of treatment at 2 years
Food Variety
Time frame: From enrollment to the end of treatment at 2 years
Glucose
Time frame: From enrollment to the end of treatment at 2 years
Hemoglobin A1c
Time frame: From enrollment to the end of treatment at 2 years
Total Cholesterol
Time frame: From enrollment to the end of treatment at 2 years
High Density Lipoprotein
Time frame: From enrollment to the end of treatment at 2 years
Low Density Lipoprotein
Time frame: From enrollment to the end of treatment at 2 years
Trygliseride
Time frame: From enrollment to the end of treatment at 2 years
Vitamin D
Time frame: From enrollment to the end of treatment at 2 years
Life Quality
Time frame: From enrollment to the end of treatment at 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Background: PubMed 23941862Shivappa N, Steck SE, Hurley TG, Hussey JR, Hebert JR. Designing and developing a literature-derived, population-based dietary inflammatory index. Public Health Nutr. 2014 Aug;17(8):1689-96. doi: 10.1017/S1368980013002115. Epub 2013 Aug 14.
- Background: PubMed 15699229Geelen A, Brouwer IA, Schouten EG, Maan AC, Katan MB, Zock PL. Effects of n-3 fatty acids from fish on premature ventricular complexes and heart rate in humans. Am J Clin Nutr. 2005 Feb;81(2):416-20. doi: 10.1093/ajcn.81.2.416.
- BackgroundKuyumcu, M. S., & Kuyumcu, A. (2020). Mediterranean diet effects on ventricular premature complexes. Annals of Medical Research, 27(1), 79.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared to protect participant confidentiality and ensure compliance with data privacy requirements.
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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.
Kerim K GÖKÜSTÜN, PhD principal investigator
Izmir Democracy University
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 Complexes and Diet Quality, run by Izmir Democracy 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 5 inclusion and 18 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: opening soon, as of the sponsor's last update on 13 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kerim K GÖKÜSTÜN, PhD (05058699031, kerimkaangokustun@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diet Inflammatory Index (time frame: From enrollment to the end of treatment at 2 years). 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 NCT07870109, 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 13 Oct 2026.