Heart Conduction Disorder, Heart Failure With Preserved Ejection Fraction, Heart Failure With Reduced Ejection Fraction
Conditions
Keywords
conduction system pacing, exercise capacity, Cardiopulmonary exercise testing
Brief summary
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.
Detailed description
Heart failure (HF) is a serious condition that affects a lot of people and places a significant burden on the healthcare system. Some HF patients also have issues with the natural electrical system of their heart, causing uneven heart contractions and worsening heart function. A treatment known as CRT has been helping such patients, but it does not work for everyone. A new technique called conduction system pacing (CSP) has emerged that might offer a more natural way of maintaining heart contractions. This study aims to determine if CSP can enhance the ability of HF patients to exercise, by looking at their maximum oxygen consumption (a measure of exercise capacity). It will also explore why some HF patients struggle with exercise more than others. Eligible patients will be randomly assigned to either the new CSP treatment or a standard pacing method (right ventricular apical pacing). Patients will be checked regularly over a follow-up period of 24 weeks. The main goal is to see if patients can exercise better with CSP after 24 weeks. The study will also look at other heart measures and safety concerns related to the devices. This study might show that CSP can help improve exercise capacity and heart function in certain HF patients. The results could guide health care professionals in offering better, tailored treatments for their patients.
Interventions
DEVICEConduction system pacing
In the conduction system pacing group, the right ventricular lead will be placed in a septal position to achieve conduction system pacing, either His bundle pacing (HBP) or left bundle branch area (LBBA) pacing. In the usual care group, the right ventricular lead will be placed in the right ventricle apex as usual.
This is the usual care group. Patients will receive a pacemaker device with the right ventricular lead inserted in the apex and not in the septal position.
Sponsors
University Hospital, Antwerp
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 ...
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exercise capacity | 24 weeks after pacemaker implantation | Change of VO2 peak from baseline to 24 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exercise capacity | 4 weeks after pacemaker implantation | Change of VO2 peak from baseline to 4 weeks |
| Echocardiographic parameters (Ejection Fraction) | 4, 12 and 24 weeks after pacemaker implantation | Change from baseline to 4,12 and 24 weeks (EF%) |
| QRS width | 4, 12 and 24 weeks after pacemaker implantation | Change from baseline to 4,12,24 weeks (msec) |
| Biomarker, N-terminal pro B-type natriuretic peptide levels | 4 and 24 weeks after pacemaker implantation | Change from baseline to 4, 24 weeks (pg/ml) |
| Health-related quality of life scores | 4,12 and 24 weeks after pacemaker implantation | KCCQS - Kansas City cardiomyopathy quality score |
Countries
Belgium
Contacts
Primary ContactAndreas Gevaert
Backup ContactFaro Verelst
Outcome results
None listed