Heart Failure With Preserved Ejection Fraction Clinical Trial
— ESCPANDOfficial title:
Exercise Capacity Improvement by Conduction System Pacing in heArt Failure patieNts Without Compelling CRT inDication
NCT number | NCT06278844 |
Other study ID # | 3020 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | December 12, 2023 |
Est. completion date | December 2027 |
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.
Status | Recruiting |
Enrollment | 75 |
Est. completion date | December 2027 |
Est. primary completion date | September 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 ... |
Country | Name | City | State |
---|---|---|---|
Belgium | Universitair Ziekenhuis Antwerpen | Edegem | Antwerp |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Antwerp |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Exercise capacity | Change of VO2 peak from baseline to 24 weeks | 24 weeks after pacemaker implantation | |
Secondary | Exercise capacity | Change of VO2 peak from baseline to 4 weeks | 4 weeks after pacemaker implantation | |
Secondary | Echocardiographic parameters (Ejection Fraction) | Change from baseline to 4,12 and 24 weeks (EF%) | 4, 12 and 24 weeks after pacemaker implantation | |
Secondary | QRS width | Change from baseline to 4,12,24 weeks (msec) | 4, 12 and 24 weeks after pacemaker implantation | |
Secondary | Biomarker, N-terminal pro B-type natriuretic peptide levels | Change from baseline to 4, 24 weeks (pg/ml) | 4 and 24 weeks after pacemaker implantation | |
Secondary | Health-related quality of life scores | KCCQS - Kansas City cardiomyopathy quality score | 4,12 and 24 weeks after pacemaker implantation |
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