Actively Recruiting
Right Ventricular Function Changes After CIED Implantation: The RIGHT-CIED Study
Led by Istanbul University - Cerrahpasa · Updated on 2025-12-16
40
Participants Needed
1
Research Sites
66 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to understand how the right side of the heart changes in people who receive an implantable cardiac electronic device (CIED), such as a pacemaker, ICD, or CRT device. The right ventricle (RV) can sometimes be affected after these devices are placed, but the reasons and timing are not well understood. To investigate this, we will examine participants at two time-points: before their device is implanted and again six months later. At each visit, we will assess heart function using echocardiography, a non-contrast cardiac MRI scan, and an ultrasound score of venous congestion called the VEXUS score. We will also take a small blood sample to measure a biomarker called FGF-23, which may reflect changes in heart function. The study does not involve any experimental treatment, and all implanted devices are part of routine medical care. The imaging tests and blood samples are for research purposes only. By comparing the measurements before and after device implantation, we hope to better understand how CIEDs influence right-sided heart function and whether imaging findings are related to changes in blood biomarkers.
CONDITIONS
Official Title
Right Ventricular Function Changes After CIED Implantation: The RIGHT-CIED Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Scheduled for implantation of a clinically indicated pacemaker, ICD, or CRT device
- Able to undergo transthoracic echocardiography, VEXUS ultrasound assessment, and non-contrast cardiac MRI
- Able to provide written informed consent
You will not qualify if you...
- Contraindication to cardiac MRI (e.g., severe claustrophobia, MRI-unsafe implanted material)
- Unable to undergo echocardiography or ultrasound assessment
- Known pulmonary arterial hypertension (Group 1 PH)
- Significant congenital heart disease
- Mechanical or bioprosthetic heart valve replacement
- Severe left-sided valvular disease (severe aortic stenosis or severe mitral regurgitation)
- Chronic kidney disease stage 4 or 5 (eGFR < 30 mL/min/1.73m²)
- End-stage renal disease requiring dialysis
- Primary hyperparathyroidism
- Hypophosphataemia or hyperphosphataemia requiring treatment
- Active or uncontrolled bone metabolism disorders (e.g., osteomalacia, Paget's disease)
- Recent fracture or major orthopedic surgery within past 3 months
- Active systemic inflammatory or autoimmune disease
- Active malignancy or malignancy requiring ongoing treatment
- Active infection at enrollment
- Pregnancy or breastfeeding
- Hemodynamic instability at enrollment
- Expected survival less than 6 months due to non-cardiac conditions
- Inability to provide informed consent
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Istanbul University-Cerrahpasa Institute of Cardiology
Istanbul, FATIH, Turkey (Türkiye), 34098
Actively Recruiting
Research Team
S
SAHRA ASENA BALCIOGLU, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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