Exercise Capacity Improvement by Conduction System Pacing in heArt Failure patieNts Without Compelling CRT inDication
Recruiting now · Not applicable
Conditions studied: Heart Failure With Reduced Ejection Fraction, Heart Failure With Preserved Ejection Fraction, Heart Conduction Disorder
In brief
This randomized controlled trial aims to investigate the impact of conduction system pacing in comparison to right ventricular apical pacing on exercise capacity, as measured by peak oxygen uptake (VO2peak), in heart failure patients with indication for pacing but no compelling indication for cardiac resynchronization therapy (CRT). The mechanisms of exercise intolerance in heart failure patients influenced by conduction system pacing will be assessed.
Key facts
- Study ID
- NCT06278844
- Run by
- University Hospital, Antwerp
- People needed
- 75
- Starts
- 2023-12-12
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2024-02-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- Universitair Ziekenhuis Antwerpen — Edegem, Antwerp, Belgium (enrolling)
Full record on ClinicalTrials.gov
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