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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03631303
Other study ID # 2018.246
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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