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

NCT07272395 | Recruiting

• 1 other identifier: 2025/619IUCIC
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Right Ventricular Dysfunction

Keywords

right ventricular dysfunction; right ventricular function; Cardiac Implantable Electronic Device; Implantable Cardioverter-Defibrillator; pacemaker; Cardiac Resynchronisation Therapy; Cardiac Magnetic Resonance Imaging; Echocardiography; VExUS; Venous Congestion; Fibroblast Growth Factor 23; Brain Natriuretic Peptide

Outcome Measures

Primary Outcomes (2)

• Change in Right Ventricular Ejection Fraction (RVEF) by Cardiac MRI

  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.

  Baseline (pre-implantation) to 6 months post-implantation

• Change in Tricuspid Regurgitation Severity

  Tricuspid regurgitation will be graded (none, mild, moderate, severe) using echocardiography and confirmed by CMR-derived regurgitant volume.

  Baseline to 6 months

Secondary Outcomes (6)

• Change in Right Ventricular End-Diastolic Volume (RVEDV) by Cardiac MRI

  Baseline to 6 months

• Change in VEXUS Score

  Baseline to 6 months

• Change in Right Ventricular Longitudinal Strain (RV-FWLS)

  Baseline to 6 months

• Change in Plasma FGF-23 Concentration

  Baseline to 6 months

• Change in BNP Concentration

  Baseline to 6 months

Study Arms (1)

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.

Other: Multimodal Right Ventricular Evaluation

Interventions

Multimodal Right Ventricular Evaluation 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.

CIED Implantation Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from the cardiology clinics and electrophysiology unit of Istanbul University-Cerrahpaşa Cardiology Institute. The study population consists of adult patients scheduled for implantation of a clinically indicated pacemaker, ICD, or CRT device. All participants represent a routine tertiary-care population referred for device therapy due to bradyarrhythmia, heart failure, or ventricular arrhythmia indications.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpasa Institute of Cardiology

Istanbul, FATIH, 34098, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• 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

  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.

  PMID: 37749114 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

EDTA plasma samples derived from venous whole blood; stored for biomarker analysis (FGF-23 and BNP). No DNA extraction will be performed.

MeSH Terms

Conditions

Ventricular Dysfunction, Right; Hyperemia

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• SAHRA ASENA BALCIOGLU

  ISTANBUL UNIVERSITY-CERRAHPASA INSTITUTE OF CARDIOLOGY

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SAHRA ASENA BALCIOGLU, MD

CONTACT

+905304433766; sahra.balcioglu@iuc.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician, Cardiology Department

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 9, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): October 21, 2026
• Study Completion (Estimated): November 25, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: IPD will be available from 12 months to 5 years after publication.
• Access Criteria: De-identified individual participant data (IPD) will be accessible to qualified researchers affiliated with recognised academic or clinical institutions. Access will be granted for the purpose of scientific analysis only, upon submission of a reasonable research proposal and approval by the study investigators. Data will be shared in an anonymised electronic format via secure data transfer. No identifiable information, imaging files, or raw MRI datasets will be provided.

Locations

TU (1)