Right Ventricular DysfunctionRIGHT-CIEDNCT07272395
Right Ventricular Function Changes After CIED Implantation: The RIGHT-CIED Study
An observational study of Right Ventricular Dysfunction, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Right Ventricular Dysfunction
- What is being tested?
- Multimodal Right Ventricular Evaluation
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2025to 25 Nov 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University-Cerrahpasa Institute of Cardiology
Istanbul, FATIH, 34098
SAHRA ASENA BALCIOGLU, MD, +905304433766, sahra.balcioglu@iuc.edu.tr
About this study
Official title: Monitoring Right Ventricular Function in Patients Undergoing Implantable Cardiac Electronic Device (CIED) Therapy: A Multimodal Imaging and Biomarker-Based Approach
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.
Read the 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
- Being tested
- Multimodal Right Ventricular Evaluation
- 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
- Medical subject headings
- Ventricular Dysfunction, Right, Hyperemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal Right Ventricular EvaluationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Multimodal Right Ventricular Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to 6 months
Secondary outcomes (6)
Change in Right Ventricular End-Diastolic Volume (RVEDV) by Cardiac MRI
RVEDV will be measured from short-axis cine stacks. The endpoint is the change in volume between baseline and 6 months.
Measured: Baseline to 6 months
Change in VEXUS Score
VEXUS venous congestion score (IVC, hepatic vein Doppler, portal vein pulsatility, renal vein Doppler) will be calculated at each visit.
Measured: Baseline to 6 months
Change in Right Ventricular Longitudinal Strain (RV-FWLS)
Measured via speckle-tracking echocardiography.
Measured: Baseline to 6 months
Change in Plasma FGF-23 Concentration
EDTA plasma FGF-23 will be measured via ELISA. The endpoint is the change in concentration from baseline to 6 months.
Measured: Baseline to 6 months
Change in BNP Concentration
Plasma BNP levels will be measured as a secondary biochemical marker.
Measured: Baseline to 6 months
Lead-related Tricuspid Valve Interaction
Based on CMR evaluation of lead-leaflet relationship (septal, posteroseptal, anterior leaflet proximity or impingement).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start15 Aug 2025
- Primary completion21 Oct 2026 (estimated)
- Study completion25 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Right Ventricular DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sahra Asena Balcioglu, Istanbul University - Cerrahpasa
- Investigators
- SAHRA ASENA BALCIOGLU, Principal investigator, ISTANBUL UNIVERSITY-CERRAHPASA INSTITUTE OF CARDIOLOGY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07272395
- Sponsor's protocol ID
- 2025/619IUCIC
- Acronym
- RIGHT-CIED
- Status last verified
- Aug 2025
- First submitted
- 27 Nov 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) related to right ventricular measurements, echocardiographic parameters, VEXUS scores, cardiac MRI-derived volumetric results, and biomarker values (FGF-23 and BNP) may be shared. No direct identifiers, imaging files, or raw MRI data will be provided. Only anonymised numerical data used for statistical analysis will be available.
Publications
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
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.
PubMed 37749114
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Right Ventricular Function in Patients Undergoing Implantable Cardiac Electronic Device (CIED) Therapy: A Multimodal Imaging and Biomarker-Based Approach
- ClinicalTrials.gov ID
- NCT07272395
- Acronym / sponsor ID
- RIGHT-CIED / 2025/619IUCIC
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 21 Oct 2026 (estimated)
- Study completion
- 25 Nov 2026 (estimated)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CIED Implantation Cohort | – | Other: Multimodal Right Ventricular EvaluationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal Right Ventricular EvaluationNon-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. | Other | CIED Implantation Cohort |
Primary outcome
Change in Right Ventricular Ejection Fraction (RVEF) by Cardiac MRI
Time frame: Baseline (pre-implantation) to 6 months post-implantation
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.
Change in Tricuspid Regurgitation Severity
Time frame: Baseline to 6 months
Tricuspid regurgitation will be graded (none, mild, moderate, severe) using echocardiography and confirmed by CMR-derived regurgitant volume.
6 secondary outcomes
Change in Right Ventricular End-Diastolic Volume (RVEDV) by Cardiac MRI
Time frame: Baseline to 6 months
Change in VEXUS Score
Time frame: Baseline to 6 months
Change in Right Ventricular Longitudinal Strain (RV-FWLS)
Time frame: Baseline to 6 months
Change in Plasma FGF-23 Concentration
Time frame: Baseline to 6 months
Change in BNP Concentration
Time frame: Baseline to 6 months
Lead-related Tricuspid Valve Interaction
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Results publicationZoghbi 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
- Results publication: PubMed 37749114Benes 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) related to right ventricular measurements, echocardiographic parameters, VEXUS scores, cardiac MRI-derived volumetric results, and biomarker values (FGF-23 and BNP) may be shared. No direct identifiers, imaging files, or raw MRI data will be provided. Only anonymised numerical data used for statistical analysis will be available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
SAHRA ASENA BALCIOGLU principal investigator
ISTANBUL UNIVERSITY-CERRAHPASA INSTITUTE OF CARDIOLOGY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Right Ventricular Dysfunction, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SAHRA ASENA BALCIOGLU, MD (+905304433766, sahra.balcioglu@iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Right Ventricular Ejection Fraction (RVEF) by Cardiac MRI (time frame: Baseline (pre-implantation) to 6 months post-implantation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07272395, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.