Post-Extrasystolic Potentiation as a Predictor of Ventricular Arrhythmias

Ventricular Tachycardia Clinical Trial

— A PRIORY  

Official title:

Post-Extrasystolic Potentiation as a Predictor of Ventricular Arrhythmias

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03631303
• Other study ID #: 2018.246
• Status: Recruiting
• Start date: September 1, 2018
• Est. completion date: March 1, 2020

Study information

• Verified date: November 2018
• Source: VU University Medical Center
• Contact: Cornelis P Allaart, MD, PhD
• Phone: +31 (0)20 4445043
• Email: cp.allaart[@]vumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 1, 2020
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Post-extrasystolic Potentiation (PESP)
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Netherlands	VU university medical center	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
VU University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

Sinnecker D, Dirschinger RJ, Barthel P, Müller 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. — View Citation

Steger A, Sinnecker D, Barthel P, Müller 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evoked PESP-BP	blood pressure differences between baseline, extrasystolic beat (ESB) and post-ESB	Measured during stimulation protocol
Primary	Spontaneous PESP-BP	blood pressure differences between baseline, extrasystolic beat (ESB) and post-ESB	Measured in rest, without cardiac stimulation with spontaneous ESB