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RecruitingNCT07396597Updated Nov 5, 2026

Physical Impairments in Premature Ventricular Complex

An observational study in Premature Ventricular Complexes, sponsored by Izmir Democracy University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by Izmir Democracy University · Observational

From the registry’s dates

  • Started Jul 2026; still recruiting 3 months later.
Updated Nov 5, 2026Now RecruitingSite recruiting status changed+1 moreGo to Updates ↓
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
52
Ages
18 Years and older
Sex
All
01

Study summary

Premature ventricular complexes may be observed in individuals without underlying disease due to factors such as physical inactivity, advanced age, smoking, male sex, and psychosocial disturbances, and in some cases may result in sudden cardiac death. Therefore, the aim of this study is to investigate respiratory function, respiratory muscle strength, cough strength, handgrip strength, physical activity level, and quality of life in individuals with premature ventricular complexes.

Read the detailed description

The primary aim of this study is to comprehensively investigate respiratory function, respiratory muscle strength, cough strength, handgrip strength, physical activity level, and quality of life in individuals with premature ventricular complexes. Additionally, an important secondary aim is to identify potential differences in these parameters between individuals with premature ventricular complexes and healthy controls and to contribute original findings to the existing literature.Participants will be evaluated in terms of these parameters through clinical assessments, questionnaires, and measurements.

02

Conditions studied

  • Premature Ventricular Complexes

Keywords

  • cough
  • muscle strength
  • quality of life
  • pulmonary function
  • ventricular premature complexes,
03

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 planned enrollment of 52 is below the median of 125 across 39 observational studies indexed under Ventricular Premature Complexes.

Browse Ventricular Premature Complexes studies →

Lead sponsor

Izmir Democracy University is the lead sponsor of 78 studies on the registry; 32 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The study population consists of adults including individuals diagnosed with symptomatic premature ventricular complexes and healthy control participants. Participants will be recruited from patients presenting to the Cardiology Department of Buca Seyfi Demirsoy Training and Research Hospital and volunteers without premature ventricular complexes.

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 for Individuals with Premature Ventricular Complexes (PVCs):

  • Aged between 18 and 80 years
  • Presence of symptomatic premature ventricular complexes resistant to ≥1 antiarrhythmic medication (including β-blockers and calcium channel blockers)
  • Premature ventricular complex burden ≥10%
  • Ventricular arrhythmias originating from any focus within the right or left ventricle
  • Physically able to participate in all study assessments
  • Willingness to participate in the study by providing written

Inclusion criteria

Inclusion Criteria for Control Group Participants:

  • Aged between 18 and 80 years
  • Healthy individuals
  • Willingness to participate in the study
  • Physically able to participate in all study assessments

Exclusion Criteria for Individuals with Premature Ventricular Complexes (PVCs):

  • (LVEF) \<45% unless PVC-induced cardiomyopathy is documented (defined as a >15% improvement in LVEF following reduction of PVC burden through pharmacological therapy or ablation)
  • Progressive decline in LVEF within the last 4 months, regardless of etiology
  • Severe heart failure classified as (NYHA) Class ≥III
  • Ventricular arrhythmias attributed to underlying structural heart disease, known myocardial scar, or myocarditis
  • Change in the dosage of antiarrhythmic medications (including β-blockers and calcium channel blockers) within 2 months prior to enrollment
  • Failed catheter ablation within 3 months prior to enrollment
  • Known thyroid disorders or individuals undergoing renal dialysis
  • \<12 months
  • Presence of angina pectoris
  • Diagnosis of (COPD) or asthma
  • Resting heart rate >120 beats/min
  • Resting systolic blood pressure ≥180 mmHg
  • Resting diastolic blood pressure ≥100 mmHg
  • Resting peripheral oxygen saturation ≤90%

Exclusion criteria

Exclusion Criteria for Control Group Participants:

  • Presence of premature ventricular complexes
  • Presence of any acute or chronic medical condition
Terms in these criteria, in plain language(5)

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.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
52 participants (estimated)
Patient registry
No

Groups and cohorts

  • Ventricular premature complexes group

    This group will consist of individuals with premature ventricular complex.

    Other: Physical Evaluations of Patients with Premature Ventricular Complex

  • Control Group

    This group will consist of healthy individuals.

    Other: Physical Evaluations of Healthy Individuals

Interventions

  • OtherPhysical Evaluations of Patients with Premature Ventricular Complex

    In this study, data from individuals with premature ventricular complex will be collected through face-to-face assessments. Respiratory functions, respiratory and peripheral muscle strength, cough strength, physical activity level, and quality of life will be assessed in these individuals who meet the inclusion criteria. All data obtained through these assessments will be collected from participants face-to-face at one time and for a maximum of approximately 1 hour.

  • OtherPhysical Evaluations of Healthy Individuals

    In this study, data from healthy individuals will be collected through face-to-face assessments. Respiratory functions, respiratory and peripheral muscle strength, cough strength, physical activity level, and quality of life will be assessed in these individuals who meet the inclusion criteria.All data obtained through these assessments will be collected from participants face-to-face at one time and for a maximum of approximately 1 hour.

06

What researchers measure

Primary outcomes

  1. Maximal inspiratory pressure (MIP)

    The MIP which shows respiratory muscle strength will be evaluated using a portable mouth pressure measuring device based on American Thoracic Society and European Respiratory Society criteria.

    Time frame: through study completion, an average of 1 year

Secondary outcomes

  1. Maximal expiratory pressure (MEP)

    The MEP which shows respiratory muscle strength will be evaluated using a portable mouth pressure measuring device based on American Thoracic Society and European Respiratory Society criteria.

    Time frame: through study completion, an average of 1 year

  2. Forced vital capacity (FVC)

    Pulmonary function (Forced vital capacity (FVC)) will be evaluated with a spirometer.

    Time frame: through study completion, an average of 1 year

  3. Forced expiratory volume in the first second (FEV1)

    Pulmonary function (Forced expiratory volume in the first second (FEV1)) will be evaluated with a spirometer.

    Time frame: through study completion, an average of 1 year

  4. FEV1 / FVC

    Pulmonary function (Forced expiratory volume in the first second/Forced vital capacity (FEV1 / FVC)) will be evaluated with a spirometer.

    Time frame: through study completion, an average of 1 year

  5. Peak flow rate (PEF)

    Pulmonary function (Peak flow rate (PEF)) will be evaluated with a spirometer.

    Time frame: through study completion, an average of 1 year

  6. Cough Strength

    Participants' peak cough expiratory flow (PCEF) values will be assessed in an upright sitting position using a peak cough flow meter (ExpiRite Peak Flow Meter, China). Following a deep inspiration, participants will be instructed to cough as forcefully as possible into the device. The best value obtained from at least three trials will be recorded.

    Time frame: through study completion, an average of 1 year

  7. Handgrip Strength

    Maximum isometric strength of the hand and forearm muscles will be measured using a hydraulic hand dynamometer.Measurements will be performed in an upright sitting position in accordance with guidelines. The mean of the three measurements for the right and left hands will be used for analysis.

    Time frame: through study completion, an average of 1 year

  8. Assessment of Physical Activity

    Participants' physical activity levels over the previous seven days will be assessed using the International Physical Activity Questionnaire-Short Form. The questionnaire consists of 7 items that assess time spent walking, and moderate- and vigorous-intensity physical activities over the last seven days. Total physical activity scores will be calculated by summing the duration (minutes) and frequency (days) of walking, moderate-intensity, and vigorous-intensity activities. Total physical activity score will be expressed as metabolic equivalent task minutes per week (MET-min/week).

    Time frame: through study completion, an average of 1 year

  9. Assessment of Quality of Life

    Participants' quality of life will be evaluated using the Short Form-36 Health Survey (SF-36). The SF-36 assesses eight health domains: general health, physical functioning, role limitations due to physical problems, role limitations due to emotional problems, social functioning, bodily pain, vitality, and mental health, along with one additional item assessing health transition. Participants will be instructed to respond to each question in a manner that best reflects their current condition, and researchers will provide clarifying guidance when necessary.

    Time frame: through study completion, an average of 1 year

07

Study locations

1 of 1 sites recruiting
  • Izmir Democracy University
    Izmir, 35140, Turkey (Türkiye)
    Recruiting
    • GÜLŞAH BARĞI · Contact0232 299 0739
    • ESRA SUDE AKIN · Contact
08

References and documents

Publications

  • Zeppenfeld K, Tfelt-Hansen J, de Riva M, Winkel BG, Behr ER, Blom NA, Charron P, Corrado D, Dagres N, de Chillou C, Eckardt L, Friede T, Haugaa KH, Hocini M, Lambiase PD, Marijon E, Merino JL, Peichl P, Priori SG, Reichlin T, Schulz-Menger J, Sticherling C, Tzeis S, Verstrael A, Volterrani M; ESC Scientific Document Group. 2022 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death. Eur Heart J. 2022 Oct 21;43(40):3997-4126. doi: 10.1093/eurheartj/ehac262. No abstract available. PubMed 36017572 ↗
  • Aktan R, Ocaker Aktan O, Ozalevli S, Dursun H. Impact of Inspiratory Muscle Strength and Lung Function on Functional Exercise Capacity in Post-myocardial Infarction Patients: A Cross-sectional Study. Thorac Res Pract. 2025 Oct 24;26(6):307-313. doi: 10.4274/ThoracResPract.2025.2025-7-5. Epub 2025 Sep 18. PubMed 40960384 ↗

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Started Jul 2026 (actual). Primary completion is estimated for Mar 2028, 19 months after the start.

Start moved once since we started tracking on Sep 25, 2026: Aug 2026 → Jul 2026, on Nov 5, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

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

Registered
Feb 1, 2026
First posted
Feb 9, 2026
StartActual
Jul 27, 2026was Aug 2026
Primary completionEst.
Mar 1, 2028
CompletionEst.
Mar 1, 2028
Last update
Nov 5, 2026
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.
Status
Not yet recruiting→Recruiting
changed Nov 5, 2026
Sites
Izmir Democracy University is now Recruiting
Nov 5, 2026
Start date
Aug 30, 2026→Jul 27, 2026 (actual)
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    Not yet recruiting→Recruiting
    Izmir Democracy University is now Recruiting
    Start date Aug 30, 2026→Jul 27, 2026 (now actual)
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07396597
Lead sponsor
Izmir Democracy University
Responsible party
Gulsah Bargi (Principal Investigator, Izmir Democracy University) — Principal investigator
First posted
Feb 9, 2026
Start date
Jul 27, 2026
Primary completion
Mar 1, 2028 (estimated)
Completion
Mar 1, 2028 (estimated)
Last update
Nov 5, 2026

Study contacts

GÜLŞAH BARĞI
Contact
gulsahbargi35@gmail.com
+90 232 299 0739
ESRA SUDE AKIN
Contact
+90 232 299 0739
GÜLŞAH BARĞI
study director · Izmir Democracy University
ESRA SUDE AKIN
principal investigator · Izmir Democracy University
DEFNE FİL
principal investigator · Izmir Democracy University
ERKAN ALPASLAN
principal investigator · Izmir Democracy University

Oversight

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

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