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Clinical Trials in Turkey / NCT07272395
Recruiting Observational

Right Ventricular Function Changes After CIED Implantation: The RIGHT-CIED Study

NCT07272395 · tracked via the Priya Life Science Turkey tracker
Sponsor
Istanbul University - Cerrahpasa
Phase
Observational
Started
2025-08-15
Last updated
2025-12-16

Condition(s) studied

Right Ventricular Dysfunction

Investigational drug(s) / intervention(s)

Multimodal Right Ventricular Evaluation

Multimodal Right Ventricular Evaluation: Non-invasive assessments including transthoracic echocardiography, VEXUS ultrasound scoring, non-contrast cardiac MRI using 1.5T scanner, and venous blood sampling for EDTA plasma biomarker analysis (FGF-23 and BNP). These procedures are for research measurements only and do not alter or replace routine clinical care. No therapeutic intervention or assignment is performed.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria * Adults aged 18 years or older. * Scheduled to undergo 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. Exclusion Criteria * Contraindication to cardiac MRI (e.g., severe claustrophobia or MRI-unsafe implanted material). * Inability to undergo echocardiography or ultrasound assessment. * Known pulmonary arterial hypertension (Group 1 PH). * Significant congenital heart disease. * Patients with mechanical or bioprosthetic heart valve replacement * Severe left-sided valvular disease (severe AS or severe MR). * 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 orthopaedic surgery within the past 3 months. * Active systemic inflammatory or autoimmune disease. * Active malignancy or malignancy requiring ongoing treatment. * Active infection at the time of enrolment. * Pregnancy or breastfeeding. * Haemodynamic instability at the time of enrolment. * Expected survival less than 6 months due to non-cardiac conditions. * Inability to provide informed consent.

Primary outcome measure(s)

  • Change in Right Ventricular Ejection Fraction (RVEF) by Cardiac MRI — Baseline (pre-implantation) to 6 months post-implantation
    RVEF will be quantified using non-contrast 1.5T cardiac MRI cine imaging. The primary endpoint is the absolute change in RVEF between pre-implantation and 6-month follow-up.
  • Change in Tricuspid Regurgitation Severity — Baseline to 6 months
    Tricuspid regurgitation will be graded (none, mild, moderate, severe) using echocardiography and confirmed by CMR-derived regurgitant volume.

Trial sites (1)

FacilityCityRegionStatus
Istanbul University-Cerrahpasa Institute of Cardiology Istanbul FATIH Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07272395 on ClinicalTrials.gov ↗ ← All trials in Turkey