Premature Ventricular ComplexesNCT07396597
Physical Impairments in Premature Ventricular Complex
An observational study of Premature Ventricular Complexes, run by Izmir Democracy University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Premature Ventricular Complexes
- What is being tested?
- Physical Evaluations of Patients with Premature Ventricular Complex and Physical Evaluations of Healthy Individuals
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Aug 2026to 1 Mar 2028
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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):
- Left ventricular ejection fraction (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)
Show all 19Show fewer
- Progressive decline in LVEF within the last 4 months, regardless of etiology
- Severe heart failure classified as New York Heart Association (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
- Life expectancy <12 months
- Presence of angina pectoris
- Diagnosis of chronic obstructive pulmonary disease (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%
Who cannot join
- Presence of premature ventricular complexes
- Presence of any acute or chronic medical condition
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
ESRA SUDE AKIN contact
Turkey (Türkiye)1 site
Izmir Democracy University
Izmir, 35140
GÜLŞAH BARĞI, 0232 299 0739
ESRA SUDE AKIN
About this study
Official title: Investigation of Respiratory Functions, Muscle Strength, Physical Activity Level, and Quality of Life in Individuals With Premature Ventricular Complexes
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.
- Conditions
- Premature Ventricular Complexes
- Being tested
- Physical Evaluations of Patients with Premature Ventricular Complex, Physical Evaluations of Healthy Individuals
- Keywords
- cough, muscle strength, quality of life, pulmonary function, ventricular premature complexes,
- Medical subject headings
- Ventricular Premature Complexes, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Evaluations of Patients with Premature Ventricular ComplexOther
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.
Physical Evaluations of Healthy IndividualsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Ventricular premature complexes group | This group will consist of individuals with premature ventricular complex. Receives: Other: Physical Evaluations of Patients with Premature Ventricular Complex | |
| Control Group | This group will consist of healthy individuals. Receives: Other: Physical Evaluations of Healthy Individuals |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 1 year
Secondary outcomes (9)
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.
Measured: through study completion, an average of 1 year
Forced vital capacity (FVC)
Pulmonary function (Forced vital capacity (FVC)) will be evaluated with a spirometer.
Measured: through study completion, an average of 1 year
Forced expiratory volume in the first second (FEV1)
Pulmonary function (Forced expiratory volume in the first second (FEV1)) will be evaluated with a spirometer.
Measured: through study completion, an average of 1 year
FEV1 / FVC
Pulmonary function (Forced expiratory volume in the first second/Forced vital capacity (FEV1 / FVC)) will be evaluated with a spirometer.
Measured: through study completion, an average of 1 year
Peak flow rate (PEF)
Pulmonary function (Peak flow rate (PEF)) will be evaluated with a spirometer.
Measured: through study completion, an average of 1 year
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.
Measured: through study completion, an average of 1 year
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.
Measured: through study completion, an average of 1 year
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).
Measured: through study completion, an average of 1 year
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start30 Aug 2026 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Democracy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulsah Bargi, Izmir Democracy University
- Investigators
- GÜLŞAH BARĞI, Study director, Izmir Democracy UniversityESRA SUDE AKIN, Principal investigator, Izmir Democracy UniversityDEFNE FİL, Principal investigator, Izmir Democracy UniversityERKAN ALPASLAN, Principal investigator, Izmir Democracy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07396597
- Sponsor's protocol ID
- Premature Ventricular Complex
- Status last verified
- Jul 2026
- First submitted
- 1 Feb 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 36017572Aktan 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
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Respiratory Functions, Muscle Strength, Physical Activity Level, and Quality of Life in Individuals With Premature Ventricular Complexes
- ClinicalTrials.gov ID
- NCT07396597
- Acronym / sponsor ID
- Premature Ventricular Complex
- Conditions
- Premature Ventricular Complexes
- Keywords
- cough, muscle strength, quality of life, pulmonary function, ventricular premature complexes,
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Izmir Democracy UniversityUniversity, hospital or other
- Study start
- 30 Aug 2026 (estimated)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 9 Feb 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.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ventricular premature complexes group | – | Other: Physical Evaluations of Patients with Premature Ventricular ComplexThis group will consist of individuals with premature ventricular complex. |
| Control Group | – | Other: Physical Evaluations of Healthy IndividualsThis group will consist of healthy individuals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (19 listed)
- Aged between 18 and 80 years
- Healthy individuals
- Willingness to participate in the study
- Physically able to participate in all study assessments
- Left ventricular ejection fraction (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)
Key exclusion criteria (2 listed)
- Presence of premature ventricular complexes
- Presence of any acute or chronic medical condition
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 |
|---|---|---|
| Physical Evaluations of Patients with Premature Ventricular ComplexIn 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. | Other | Ventricular premature complexes group |
| Physical Evaluations of Healthy IndividualsIn 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. | Other | Control Group |
Primary outcome
Maximal inspiratory pressure (MIP)
Time frame: through study completion, an average of 1 year
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.
9 secondary outcomes
Maximal expiratory pressure (MEP)
Time frame: through study completion, an average of 1 year
Forced vital capacity (FVC)
Time frame: through study completion, an average of 1 year
Forced expiratory volume in the first second (FEV1)
Time frame: through study completion, an average of 1 year
FEV1 / FVC
Time frame: through study completion, an average of 1 year
Peak flow rate (PEF)
Time frame: through study completion, an average of 1 year
Cough Strength
Time frame: through study completion, an average of 1 year
Handgrip Strength
Time frame: through study completion, an average of 1 year
Assessment of Physical Activity
Time frame: through study completion, an average of 1 year
Assessment of Quality of Life
Time frame: through study completion, an average of 1 year
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 7 Jul 2026.
- Background: PubMed 36017572Zeppenfeld 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.
- Background: PubMed 40960384Aktan 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.
- Individual participant dataSharing planned: No
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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.
ESRA SUDE AKIN contact
GÜLŞAH BARĞI study director
Izmir Democracy University
ESRA SUDE AKIN principal investigator
Izmir Democracy University
DEFNE FİL 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, 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 19 inclusion and 2 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 7 Jul 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 GÜLŞAH BARĞI (+90 232 299 0739, gulsahbargi35@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal inspiratory pressure (MIP) (time frame: through study completion, an average of 1 year). 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 NCT07396597, which also lists 2 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 7 Jul 2026.