Post-extrasystolic Potentiation (PESP)A PRIORYNCT03631303
Post-Extrasystolic Potentiation as a Predictor of Ventricular Arrhythmias
An observational study of Post-extrasystolic Potentiation (PESP) and Ventricular Tachycardia, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial summary
Background: Patients at increased risk for sudden cardiac death (SCD) may receive an implantable cardioverter defibrillator (ICD). The primary criterion for a primary prevention ICD implantation is a left ventricular ejection fraction (LVEF) below 35%, but refinement of ICD criteria is important since only a small… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-extrasystolic Potentiation (PESP), Ventricular Tachycardia
- What is being tested?
- Cardiac stimulation through the device leads
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Sep 2018to 1 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: 30 patients who are scheduled for device replacement or reposition, are eligible for this study; (1) 10 ICD patients who previously received appropriate device therapy (ATP/shock); (2) 10 ICD patients who are free from ADT and (3) 10 dual-chamber pacemaker patients (control group)
Who may be able to join
- Implanted with a dual-chamber device
- For ICD patients: a LVEF ≤35%, measured recently
- For Pacemaker patients: a LVEF > 50% measured both recently
- A device follow-up of at least one year must be available
- Optimal (stable) medical therapy
- Sinus rhythm
Who cannot join
- Age <18 or incapacitated adult
- Unknown left ventricular function prior to device implantation
- Patients unwilling to participate
- Documented atrial fibrillation
- Second or third degree atrioventricular (AV) conduction disorders;
- Patients with a cardiac resynchronization therapy (CRT-D) or one-chamber device
- Hypertrophic cardiomyopathy
- Conditions with insufficient blood flow to the fingers, e.g. M. Raynaud or conditions with extreme vasoconstriction
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
VU university medical center
Amsterdam, 1081HV
Anne-Lotte van der Lingen, MD, +31204443272, a.vanderlingen@vumc.nl
About this study
Background: Patients at increased risk for sudden cardiac death (SCD) may receive an implantable cardioverter defibrillator (ICD). The primary criterion for a primary prevention ICD implantation is a left ventricular ejection fraction (LVEF) below 35%, but refinement of ICD criteria is important since only a small proportion of ICD patients receives appropriate device therapy (ATP or a shock) during follow-up. Post-extrasystolic potentiation (PESP) may be a new risk marker for SCD. PESP is defined as a temporary increase in contractility that follows an extrasystolic beat (ESB) and is associated with myocardial calcium handling. In heart failure, changes in calcium homeostasis may lead to afterdepolarisations and thus predispose for SCD. PESP can be measured indirectly and non-invasively as post-extrasystolic blood pressure potentiation (PESP-BP). Abnormal PESP-BP was previously found to be an independent predictor of increased mortality in post-myocardial infarction patients with a reduced LVEF. However, it is unknown if this increased mortality in heart failure patients with abnormal PESP-BP is caused by an increased risk of SCD.
Hypothesis: The investigators hypothesize that PESP-BP might be a new predictor of the occurrence of SCD, and can be used to enhance patient selection for primary prevention ICD therapy.
Read more
Design: During scheduled device replacement ESB with various extrasystolic and post-extrasystolic coupling intervals will be evoked by electrical stimulation via the right atrial and ventricular device leads of the patient. Throughout the stimulation study blood pressure will be measured non-invasively a continuous electrocardiogram will be recorded. Either before or after the procedure, patients will undergo a 30-minutes assessment of spontaneous ESB, again with blood pressure and ECG recordings.
Study population: 30 patients who are scheduled for device replacement or reposition, are eligible for this study; (1) 10 ICD patients who previously received appropriate device therapy (ADT); (2) 10 ICD patients who are free from ADT and (3) 10 dual-chamber pacemaker patients (control group).
Outcomes: (1) Evoked PESP-BP (i.e. blood pressure differences between baseline, ESB and post-ESB); (2) Spontaneous PESP-BP (i.e. blood pressure differences between baseline, ESB and post-ESB); (3) Timing parameters (in ms): the basic cycle length interval; Extra-systolic interval (ESI); Post-extrasystolic interval (PESI).
- Being tested
- Cardiac stimulation through the device leads
- Keywords
- Implantable cardioverter defibrillator, Post-extrasystolic Potentiation, Sudden Cardiac Death
- Medical subject headings
- Tachycardia, Ventricular, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac stimulation through the device leadsDevice
During scheduled device replacement extra-systolic beats with various extrasystolic and post-extrasystolic coupling intervals will be evoked by electrical stimulation via the right atrial and ventricular device leads of the patient. Throughout the stimulation study blood pressure will be measured non-invasively using a finger arterial blood pressure photoplethysmographic device and a continuous electrocardiogram will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| ICD patients with ATP/shock | 10 primary prevention 2-chamber ICD patients (LVEF <35 percent) who received appropriate ICD therapy during follow-up. Receives: Device: Cardiac stimulation through the device leads | |
| ICD patients without ATP/Shock | 10 primary prevention 2-chamber ICD patients (LVEF <35 percent) who were free from appropriate ICD therapy during follow-up. Receives: Device: Cardiac stimulation through the device leads | |
| Pacemaker-patients | 10 2-chamber pacemaker-patients (LVEF >50%). Receives: Device: Cardiac stimulation through the device leads |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evoked PESP-BP
blood pressure differences between baseline, extrasystolic beat (ESB) and post-ESB
Measured: Measured during stimulation protocol
Spontaneous PESP-BP
blood pressure differences between baseline, extrasystolic beat (ESB) and post-ESB
Measured: Measured in rest, without cardiac stimulation with spontaneous ESB
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start1 Sep 2018
- Primary completion1 Sep 2019 (estimated)
- Study completion1 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post-extrasystolic Potentiation (PESP)Studies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cornelis P. Allaart, Amsterdam UMC, location VUmc
- Investigators
- Cornelis P. Allaart, MD, PhD, Principal investigator, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03631303
- Sponsor's protocol ID
- 2018.246
- Acronym
- A PRIORY
- Status last verified
- Nov 2018
- First submitted
- 12 Aug 2018
- Last updated
- 20 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Steger A, Sinnecker D, Barthel P, Muller A, Gebhardt J, Schmidt G. Post-extrasystolic Blood Pressure Potentiation as a Risk Predictor in Cardiac Patients. Arrhythm Electrophysiol Rev. 2016 May;5(1):27-30. doi: 10.15420/aer.2016.14.2.
PubMed 27403290Sinnecker D, Dirschinger RJ, Barthel P, Muller A, Morley-Davies A, Hapfelmeier A, Dommasch M, Huster KM, Hasenfuss G, Laugwitz KL, Malik M, Schmidt G. Postextrasystolic blood pressure potentiation predicts poor outcome of cardiac patients. J Am Heart Assoc. 2014 Jun 3;3(3):e000857. doi: 10.1161/JAHA.114.000857.
PubMed 24895163
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Extrasystolic Potentiation as a Predictor of Ventricular Arrhythmias
- ClinicalTrials.gov ID
- NCT03631303
- Acronym / sponsor ID
- A PRIORY / 2018.246
- Keywords
- Implantable cardioverter defibrillator, Post-extrasystolic Potentiation, Sudden Cardiac Death
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Sep 2019 (estimated)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 15 Aug 2018 (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.
Background: Patients at increased risk for sudden cardiac death (SCD) may receive an implantable cardioverter defibrillator (ICD). The primary criterion for a primary prevention ICD implantation is a left ventricular ejection fraction (LVEF) below 35%, but refinement of ICD criteria is important since only a small proportion of ICD patients receives appropriate device therapy (ATP or a shock) during follow-up. Post-extrasystolic potentiation (PESP) may be a new risk marker for SCD. PESP is defined as a temporary increase in contractility that follows an extrasystolic beat (ESB) and is associated with myocardial calcium handling. In heart failure, changes in calcium homeostasis may lead to afterdepolarisations and thus predispose for SCD. PESP can be measured indirectly and non-invasively as post-extrasystolic blood pressure potentiation (PESP-BP). Abnormal PESP-BP was previously found to be an independent predictor of increased mortality in post-myocardial infarction patients with a reduced LVEF. However, it is unknown if this increased mortality in heart failure patients with abnormal PESP-BP is caused by an increased risk of SCD.
Hypothesis: The investigators hypothesize that PESP-BP might be a new predictor of the occurrence of SCD, and can be used to enhance patient selection for primary prevention ICD therapy.
Design: During scheduled device replacement ESB with various extrasystolic and post-extrasystolic coupling intervals will be evoked by electrical stimulation via the right atrial and ventricular device leads of the patient. Throughout the stimulation study blood pressure will be measured non-invasively a continuous electrocardiogram will be recorded. Either before or after the procedure, patients will undergo a 30-minutes assessment of spontaneous ESB, again with blood pressure and ECG recordings.
Study population: 30 patients who are scheduled for device replacement or reposition, are eligible for this study; (1) 10 ICD patients who previously received appropriate device therapy (ADT); (2) 10 ICD patients who are free from ADT and (3) 10 dual-chamber pacemaker patients (control group).
Outcomes: (1) Evoked PESP-BP (i.e. blood pressure differences between baseline, ESB and post-ESB); (2) Spontaneous PESP-BP (i.e. blood pressure differences between baseline, ESB and post-ESB); (3) Timing parameters (in ms): the basic cycle length interval; Extra-systolic interval (ESI); Post-extrasystolic interval (PESI).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ICD patients with ATP/shock | – | Device: Cardiac stimulation through the device leads10 primary prevention 2-chamber ICD patients (LVEF <35 percent) who received appropriate ICD therapy during follow-up. |
| ICD patients without ATP/Shock | – | Device: Cardiac stimulation through the device leads10 primary prevention 2-chamber ICD patients (LVEF <35 percent) who were free from appropriate ICD therapy during follow-up. |
| Pacemaker-patients | – | Device: Cardiac stimulation through the device leads10 2-chamber pacemaker-patients (LVEF >50%). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 30 patients who are scheduled for device replacement or reposition, are eligible for this study; (1) 10 ICD patients who previously received appropriate device therapy (ATP/shock); (2) 10 ICD patients who are free from ADT and (3) 10 dual-chamber pacemaker patients (control group)
Key inclusion criteria (6 listed)
- Implanted with a dual-chamber device
- For ICD patients: a LVEF ≤35%, measured recently
- For Pacemaker patients: a LVEF > 50% measured both recently
- A device follow-up of at least one year must be available
- Optimal (stable) medical therapy
Key exclusion criteria (8 listed)
- Age <18 or incapacitated adult
- Unknown left ventricular function prior to device implantation
- Patients unwilling to participate
- Documented atrial fibrillation
- Second or third degree atrioventricular (AV) conduction disorders;
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 |
|---|---|---|
| Cardiac stimulation through the device leadsDuring scheduled device replacement extra-systolic beats with various extrasystolic and post-extrasystolic coupling intervals will be evoked by electrical stimulation via the right atrial and ventricular device leads of the patient. Throughout the stimulation study blood pressure will be measured non-invasively using a finger arterial blood pressure photoplethysmographic device and a continuous electrocardiogram will be recorded. | Device | ICD patients with ATP/shock, ICD patients without ATP/Shock, Pacemaker-patients |
Primary outcome
Evoked PESP-BP
Time frame: Measured during stimulation protocol
blood pressure differences between baseline, extrasystolic beat (ESB) and post-ESB
Spontaneous PESP-BP
Time frame: Measured in rest, without cardiac stimulation with spontaneous ESB
blood pressure differences between baseline, extrasystolic beat (ESB) and post-ESB
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
- Background: PubMed 27403290Steger A, Sinnecker D, Barthel P, Muller A, Gebhardt J, Schmidt G. Post-extrasystolic Blood Pressure Potentiation as a Risk Predictor in Cardiac Patients. Arrhythm Electrophysiol Rev. 2016 May;5(1):27-30. doi: 10.15420/aer.2016.14.2.
- Background: PubMed 24895163Sinnecker D, Dirschinger RJ, Barthel P, Muller A, Morley-Davies A, Hapfelmeier A, Dommasch M, Huster KM, Hasenfuss G, Laugwitz KL, Malik M, Schmidt G. Postextrasystolic blood pressure potentiation predicts poor outcome of cardiac patients. J Am Heart Assoc. 2014 Jun 3;3(3):e000857. doi: 10.1161/JAHA.114.000857.
- Individual participant dataSharing planned: Undecided
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. This study is not recruiting at the moment.
Cornelis P. Allaart, MD, PhD principal investigator
Amsterdam UMC, location VUmc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-extrasystolic Potentiation (PESP) and Ventricular Tachycardia, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 20 Nov 2018. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cornelis P Allaart, MD, PhD (+31 (0)20 4445043, cp.allaart@vumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evoked PESP-BP (time frame: Measured during stimulation protocol). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03631303, which also lists 2 linked publications.
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 20 Nov 2018.