Post-Extrasystolic Potentiation as a Predictor of Ventricular Arrhythmias

NCT ID: NCT03631303

Last Updated: 2018-11-20

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2020-03-01

Brief 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 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).

Conditions

Post-extrasystolic Potentiation (PESP); Ventricular Tachycardia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

ICD patients with ATP/shock

10 primary prevention 2-chamber ICD patients (LVEF \<35 percent) who received appropriate ICD therapy during follow-up.

Cardiac stimulation through the device leads

Intervention Type: DEVICE

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.

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.

Cardiac stimulation through the device leads

Intervention Type: DEVICE

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.

Pacemaker-patients

10 2-chamber pacemaker-patients (LVEF \>50%).

Cardiac stimulation through the device leads

Intervention Type: DEVICE

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.

Interventions

Cardiac stimulation through the device leads

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amsterdam UMC, location VUmc

OTHER

Sponsor Role: lead

Responsible Party

Cornelis P. Allaart

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cornelis P. Allaart, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC, location VUmc

Locations

VU university medical center

Amsterdam, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Cornelis P Allaart, MD, PhD

Role: CONTACT

cp.allaart@vumc.nl

+31 (0)20 4445043

Anne-Lotte CJ van der Lingen, MD

Role: CONTACT

a.vanderlingen@vumc.nl

+31 (0)20-4443272

Facility Contacts

Anne-Lotte van der Lingen, MD

Role: primary

a.vanderlingen@vumc.nl

+31204443272

References

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.

Reference Type: BACKGROUND

PMID: 27403290 (View on PubMed)

Sinnecker 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.

Reference Type: BACKGROUND

PMID: 24895163 (View on PubMed)

Other Identifiers

2018.246

Identifier Type: -

Identifier Source: org_study_id