Improving exercise capacity in heart failure patients using conduction system pacing

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 randomized controlled trial investigates the effects of conduction system pacing (CSP) compared to right ventricular apical pacing on exercise capacity in heart failure patients who require pacing but do not have a compelling indication for cardiac resynchronization therapy (CRT). The study will measure peak oxygen uptake (VO2peak) to assess improvements in exercise capacity over a 24-week follow-up period. Additionally, it aims to explore the mechanisms behind exercise intolerance in these patients. Eligible participants will be randomly assigned to receive either CSP or standard pacing, with regular evaluations to monitor heart function and safety concerns related to the pacing devices.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Patients with heart failure as defined by European Society of Cardiology guidelines

* Signs and/or symptoms of heart failure
* AND LVEF \<50% OR LVEF ≥50% and objective evidence of cardiac structural and/or functional abnormalities consistent with the presence of LV diastolic dysfunction/raised filling pressures
* AND indication for cardiac pacing as defined by European Society of Cardiology guidelines

Exclusion Criteria:

* Age under 18 years old
* Pregnancy
* Inability to provide consent or to undergo follow-up
* Class 1A indication for classical CRT as defined by European Society of Cardiology guidelines. Patients with a class 2A or higher indication for CRT can be included. However, patients with Class 1A indication for classical CRT but failure or suboptimal result of CS lead placement can be included.
* Significant cardiac or extracardiac comorbidity precluding maximal exercise testing, examples: Recent (\<4 weeks) decompensation of heart failure, angina pectoris class ≥2 , uncontrolled hypertension or arrhythmia , severe valvular heart disease, significant peripheral vascular disease, orthopaedic limitation ...
* Comorbidity that may influence 6-month prognosis, examples:

Severe chronic kidney disease (eGFR ≤20 mL/kg/min or dialysis) , severe chronic obstructive pulmonary disease (≥GOLD 3) , active malignancy ...

Where it's running

• Universitair Ziekenhuis Antwerpen
  Edegem, Antwerp, Belgium Recruiting

Study contacts

• Principal investigator: Andreas Gevaert — University Hospital, Antwerp
• Study coordinator: Andreas Gevaert
• Email: Andreas.gevaert@uza.be
• Phone: 038213538

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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.