NCT07253909

Upper Extremity Function in Patients With Reduced Ejection Fraction Heart Failure and Cardiac Implantable Electronic Devices

Investigation of Factors Determining Upper Extremity Function in Patients With Reduced Ejection Fraction Heart Failure and Cardiac Implantable Electronic Devices

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 72 (estimated)
• Sponsor: Hacettepe University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate in detail the factors that determine upper extremity function, determine its effect on prognosis, hospital admission, hospitalization, and mortality, and examine the results according to the use of different implantable cardiac implantable electronic devices.

Detailed description

In accordance with the inclusion and exclusion criteria appropriate to the purpose of the study, patients with a diagnosis of reduced ejection fraction heart failure and a cardiac implantable electronic device will be included. The demographic and clinical data of the individuals will be recorded. Their functional levels will be determined according to the New York Heart Association (NYHA) classification. Hand grip strength will be measured using a hand dynamometer, upper extremity anaerobic capacity will be assessed using a medicine ball throw test, upper extremity aerobic capacity will be evaluated using an arm ergometer test, and upper extremity functional exercise capacity will be assessed using the Unsupported Upper-limb Exercise Test (UULEX) and the Upper Limb Functional Test (ULIFT). Lower extremity functional capacity will be determined using the one-minute sit-to-stand test, and lower extremity performance will be determined using the 4-meter walk test. The Seattle Heart Failure Model will be used to estimate mortality risk and average life expectancy. Upper extremity functional status will be assessed using the Quick Disability of the Arm, Shoulder, and Hand Questionnaire, activities of daily living using the Katz Activities of Daily Living Scale, and quality of life using the Minnesota Quality of Life Scale. Comorbidity status will be determined using the Charlson Comorbidity Index.

Conditions

• Heart Failure
• Implantable Cardioverter Defibrillator (ICD)
• Cardiac Resynchronisation Therapy (CRT)
• Reduced Ejection Fraction Heart Failure

Interventions

Type	Name	Description
OTHER	Not applicable- observational study	Not applicable- observational study

Timeline

• Start date: 2025-05-30
• Primary completion: 2026-08-30
• Completion: 2027-05-30
• First posted: 2025-11-28
• Last updated: 2025-11-28

Locations

1 site across 1 country: Turkey (Türkiye)