NCT07272395 Right Ventricular Function Changes After CIED Implantation: The RIGHT-CIED Study
| NCT ID | NCT07272395 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istanbul University - Cerrahpasa |
| Condition | Right Ventricular Dysfunction |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-08-15 |
| Primary Completion | 2026-10-21 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2025-08-15 with a primary completion date of 2026-10-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
SAHRA ASENA BALCIOGLU
PRINCIPAL INVESTIGATOR
ISTANBUL UNIVERSITY-CERRAHPASA INSTITUTE OF CARDIOLOGY
Frequently Asked Questions
Who can join the NCT07272395 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Right Ventricular Dysfunction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07272395 currently recruiting?
Yes, NCT07272395 is actively recruiting participants. Contact the research team at sahra.balcioglu@iuc.edu.tr for enrollment information.
Where is the NCT07272395 trial being conducted?
This trial is being conducted at Istanbul, Turkey (Türkiye).
Who is sponsoring the NCT07272395 clinical trial?
NCT07272395 is sponsored by Istanbul University - Cerrahpasa. The principal investigator is SAHRA ASENA BALCIOGLU at ISTANBUL UNIVERSITY-CERRAHPASA INSTITUTE OF CARDIOLOGY. The trial plans to enroll 40 participants.