Heart Failure With Reduced Ejection FractionESCPANDNCT06278844
Exercise Capacity Improvement by Conduction System Pacing in heArt Failure patieNts Without Compelling CRT inDication
A study testing Conduction system pacing and Right ventricular apical pacing in people with Heart Failure With Reduced Ejection Fraction and Heart Failure With Preserved Ejection Fraction, run by University Hospital, Antwerp at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction, Heart Failure With Preserved Ejection Fraction, Heart Conduction Disorder
- What is being tested?
- Conduction system pacing and Right ventricular apical pacing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Dec 2023to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 ...
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Universitair Ziekenhuis Antwerpen
Edegem, Antwerp, 2650
Faro Verelst, 038213538, faro.verelst@uza.be
About this study
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.
Read the 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.
- Conditions
- Heart Failure With Reduced Ejection Fraction, Heart Failure With Preserved Ejection Fraction, Heart Conduction Disorder
- Being tested
- Conduction system pacing, Right ventricular apical pacing
- Keywords
- conduction system pacing, exercise capacity, Cardiopulmonary exercise testing
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conduction system pacingDevice
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.
Right ventricular apical pacingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Conduction system pacing | Experimental | 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. Receives: Device: Conduction system pacing |
| Right ventricular apical pacing | Active comparator | Control group, in this group patients will receive a pacemaker with the ventricular lead in the right ventricle apex. Receives: Device: Right ventricular apical pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise capacity
Change of VO2 peak from baseline to 24 weeks
Measured: 24 weeks after pacemaker implantation
Secondary outcomes (5)
Exercise capacity
Change of VO2 peak from baseline to 4 weeks
Measured: 4 weeks after pacemaker implantation
Echocardiographic parameters (Ejection Fraction)
Change from baseline to 4,12 and 24 weeks (EF%)
Measured: 4, 12 and 24 weeks after pacemaker implantation
QRS width
Change from baseline to 4,12,24 weeks (msec)
Measured: 4, 12 and 24 weeks after pacemaker implantation
Biomarker, N-terminal pro B-type natriuretic peptide levels
Change from baseline to 4, 24 weeks (pg/ml)
Measured: 4 and 24 weeks after pacemaker implantation
Health-related quality of life scores
KCCQS - Kansas City cardiomyopathy quality score
Measured: 4,12 and 24 weeks after pacemaker implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start12 Dec 2023
- Primary completionSep 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas Gevaert, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06278844
- Sponsor's protocol ID
- 3020
- Acronym
- ESCPAND
- Status last verified
- Jan 2024
- First submitted
- 7 Feb 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Capacity Improvement by Conduction System Pacing in heArt Failure patieNts Without Compelling CRT inDication
- ClinicalTrials.gov ID
- NCT06278844
- Acronym / sponsor ID
- ESCPAND / 3020
- Conditions
- Heart Failure With Reduced Ejection Fraction, Heart Failure With Preserved Ejection Fraction, Heart Conduction Disorder
- Keywords
- conduction system pacing, exercise capacity, Cardiopulmonary exercise testing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 26 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conduction system pacing | Experimental | Device: Conduction system pacingIn 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. |
| Right ventricular apical pacing | Active comparator | Device: Right ventricular apical pacingControl group, in this group patients will receive a pacemaker with the ventricular lead in the right ventricle apex. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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 ...
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conduction system pacingIn 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. | Device | Conduction system pacing |
| Right ventricular apical pacingThis 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. | Device | Right ventricular apical pacing |
Primary outcome
Exercise capacity
Time frame: 24 weeks after pacemaker implantation
Change of VO2 peak from baseline to 24 weeks
5 secondary outcomes
Exercise capacity
Time frame: 4 weeks after pacemaker implantation
Echocardiographic parameters (Ejection Fraction)
Time frame: 4, 12 and 24 weeks after pacemaker implantation
QRS width
Time frame: 4, 12 and 24 weeks after pacemaker implantation
Biomarker, N-terminal pro B-type natriuretic peptide levels
Time frame: 4 and 24 weeks after pacemaker implantation
Health-related quality of life scores
Time frame: 4,12 and 24 weeks after pacemaker implantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andreas Gevaert principal investigator
University Hospital, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conduction system pacing and Right ventricular apical pacing in people with Heart Failure With Reduced Ejection Fraction and Heart Failure With Preserved Ejection Fraction, run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andreas Gevaert (038213538, Andreas.gevaert@uza.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise capacity (time frame: 24 weeks after pacemaker implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.