Right-side heart function after pacemaker, ICD, or CRT implantation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective observational cohort of adults scheduled for clinically indicated pacemaker, ICD, or CRT implantation, with evaluations immediately before implantation and at six months. At each visit participants undergo transthoracic echocardiography with quantitative RV measures, a standardized VEXUS ultrasound score for systemic venous congestion, non-contrast cardiac MRI for RV volumetry and tissue characterization, and a blood draw for the biomarker FGF-23. No experimental devices or therapies are used; imaging and blood sampling are performed for research only and carry minimal additional risk. The study aims to quantify short-term changes in RV size and function after device implantation and to explore whether imaging changes correlate with venous congestion or biomarker shifts.

Why it matters

Who can join: the full rules

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.

Where it's running

• Istanbul University-Cerrahpasa Institute of Cardiology
  Istanbul, Fatih, Turkey (Türkiye) Recruiting

Study contacts

• Principal investigator: Sahra Asena Balcioglu — Istanbul University-Cerrahpasa Institute of Cardiology
• Study coordinator: Sahra Asena Balcioglu, Md
• Email: sahra.balcioglu@iuc.edu.tr
• Phone: +905304433766

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.