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

NCT ID: NCT07272395

Last Updated: 2025-12-16

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-15
• Study Completion Date: 2026-11-25

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.

Detailed Description

Right ventricular (RV) dysfunction and tricuspid valve changes are increasingly recognised in patients who receive implantable cardiac electronic devices (CIEDs). Potential mechanisms include lead-leaflet interaction, pacing-related alterations in RV mechanics and changes in venous haemodynamics. However, prospective data integrating advanced imaging, ultrasound-based congestion assessment and circulating biomarkers remain limited.

This prospective observational cohort study will evaluate RV structure and function at two predefined time-points: immediately before CIED implantation and at six months after implantation. Assessments will include (1) transthoracic echocardiography with quantitative RV parameters, (2) a standardised VEXUS ultrasound score for systemic venous congestion, (3) non-contrast cardiac magnetic resonance (CMR) imaging for RV volumetry and tissue characterisation and (4) plasma measurement of FGF-23 as a biomarker potentially associated with RV remodelling.

All implanted devices are clinically indicated and form part of routine care; no experimental device or therapeutic intervention is used. Imaging and blood sampling performed for the study are non-interventional and carry minimal risk. The purpose of the study is to quantify changes in RV size and function over six months and to explore whether alterations in imaging findings correspond to changes in venous congestion or biomarker levels. The results may help identify patients at risk of adverse RV remodelling following CIED implantation.

Conditions

Right Ventricular Dysfunction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

CIED Implantation Cohort

Participants with an indication for the implantation of an implantable cardiac electronic device (pacemaker, ICD, or CRT) as part of routine clinical care. All participants will undergo detailed assessment of right ventricular structure and function immediately before device implantation and again at 6 months after implantation. Assessments include transthoracic echocardiography, VEXUS ultrasound scoring, non-contrast cardiac MRI, and blood sampling for biomarker analysis (FGF-23 and BNP). No experimental intervention is administered; all implanted devices are clinically indicated.

Multimodal Right Ventricular Evaluation

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: lead

Responsible Party

Sahra Asena Balcioglu

Resident Physician, Cardiology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

SAHRA ASENA BALCIOGLU

Role: PRINCIPAL_INVESTIGATOR

ISTANBUL UNIVERSITY-CERRAHPASA INSTITUTE OF CARDIOLOGY

Locations

Istanbul University-Cerrahpasa Institute of Cardiology

Istanbul, FATIH, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

SAHRA ASENA BALCIOGLU, MD

Role: CONTACT

sahra.balcioglu@iuc.edu.tr

+905304433766

Facility Contacts

SAHRA ASENA BALCIOGLU, MD

Role: primary

sahra.balcioglu@iuc.edu.tr

+905304433766

References

Zoghbi WA, Addetia K, Bhave PD, et al. Tricuspid Regurgitation in Patients With Cardiac Implantable Electronic Devices: JACC Scientific Expert Panel. J Am Coll Cardiol. 2023;82(13):1284-1302. PMID: 37708963

Reference Type: RESULT

Benes J, Kroupova K, Kotrc M, Petrak J, Jarolim P, Novosadova V, Kautzner J, Melenovsky V. FGF-23 is a biomarker of RV dysfunction and congestion in patients with HFrEF. Sci Rep. 2023 Sep 25;13(1):16004. doi: 10.1038/s41598-023-42558-4.

Reference Type: RESULT

PMID: 37749114 (View on PubMed)

Other Identifiers

2025/619IUCIC

Identifier Type: -

Identifier Source: org_study_id