Physical Impairments in Premature Ventricular Complex

NCT07396597 | Not Yet Recruiting

• 1 other identifier: Premature Ventricular Complex
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Premature Ventricular Complexes

Keywords

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

Outcome Measures

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.

  through study completion, an average of 1 year

Secondary Outcomes (9)

• Maximal expiratory pressure (MEP)

  through study completion, an average of 1 year

• Forced vital capacity (FVC)

  through study completion, an average of 1 year

• Forced expiratory volume in the first second (FEV1)

  through study completion, an average of 1 year

• FEV1 / FVC

  through study completion, an average of 1 year

• Peak flow rate (PEF)

  through study completion, an average of 1 year

Study Arms (2)

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

Physical Evaluations of Patients with Premature Ventricular Complex OTHER

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.

Ventricular premature complexes group

Physical Evaluations of Healthy Individuals OTHER

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.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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)
• 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%
• Presence of premature ventricular complexes

Sponsors & Collaborators

• Izmir Democracy University: lead

Study Sites (1)

Izmir Democracy University

Izmir, 35140, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 36017572 BACKGROUND

• 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.

  PMID: 40960384 BACKGROUND

MeSH Terms

Conditions

Ventricular Premature Complexes; Cough

Interventions

Polyvinyl Chloride

Condition Hierarchy (Ancestors)

Cardiac Complexes, Premature; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Plastics; Polymers; Macromolecular Substances; Elastomers; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• GÜLŞAH BARĞI

  Izmir Democracy University

  STUDY DIRECTOR

• ESRA SUDE AKIN

  Izmir Democracy University

  PRINCIPAL INVESTIGATOR

• DEFNE FİL

  Izmir Democracy University

  PRINCIPAL INVESTIGATOR

• ERKAN ALPASLAN

  Izmir Democracy University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

GÜLŞAH BARĞI

CONTACT

+90 232 299 0739; gulsahbargi35@gmail.com

ESRA SUDE AKIN

CONTACT

+90 232 299 0739

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 1, 2026
• First Posted: February 9, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)