Right Ventricular Function Changes After CIED Implantation: The RIGHT-CIED Study (NCT07272395) | Clinical Trial Compass
RecruitingNot Applicable
Right Ventricular Function Changes After CIED Implantation: The RIGHT-CIED Study
Turkey (Türkiye)40 participantsStarted 2025-08-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Right Ventricular Ejection Fraction (RVEF) by Cardiac MRI
Timeframe: Baseline (pre-implantation) to 6 months post-implantation