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

Recruitingn/aAges 18 Years - anyAllIstanbul University - Cerrahpasa
NCT07272395 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 fo

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📋 Eligibility rules (as published)
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.
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What it tests

  • Multimodal Right Ventricular Evaluation
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Where

1 site
Istanbul University-Cerrahpasa Institute of Cardiology
Istanbul, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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